Federalism accountability: "Agency-Forcing" measures

Duke Law Journal

Volumn 58, Issue 8, 2009, Pages 2125-2192

  Sharkey, Catherine M ^a  

^a NEW YORK UNIVERSITY SCHOOL OF LAW   (United States)

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EID: 68049092963     PISSN: 00127086     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (315)

1. See infra Part I.
2. See Wyeth v. Levine, 129 S. Ct. 1187, 1191 (2009) (holding that FDA approval of warnings on a pharmaceutical company's label did not provide a complete defense to state tort claims); Altria Group, Inc. v. Good, 129 S. Ct. 538, 551 (2008) (holding that a state fraud claim against a cigarette manufacturer was not preempted by federal law)
3. Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008), aff'g by an equally divided Court Desiano v. Warner-Lambert & Co., 467 F.3d 85, 87 (2d Cir. 2006) (holding that federal law did not preempt a state tort law providing a "fraud-on-the-FDA" exception to state immunity for drug manufacturers whose drugs are approved by the FDA); Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1011 (2008) (holding that a federal statute regulating medical devices preempts state tort law when the device at issue had received FDA premarket approval).
4. See Food and Drug Administration Globalization Act of 2009, H.R. 759, 111th Cong. § 2 (2009) (providing "savings" language to the FDCA to the effect that neither the Act nor any amendments thereto "may. .. be construed as modifying or otherwise affecting any action or the liability of any person. .. under the law of any State"); see also Medical Device Safety Act of 2009, H.R. 1346, 111th Cong. (introduced Mar. 5, 2009 and referred to the Subcommittee on Health Mar. 6, 2009); Medical Device Safety Act of 2008, S. 3398, 110th Cong. (2008) (providing a savings clause and effectively overturning Riegel); Medical Device Safety Act of 2008, H.R. 6381, 110th Cong. (2008) (same)
5. Barry Meier, Life, Death and Liability: An Effort to Restore the Right to Sue Device Makers, N.Y. TIMES, Feb. 20, 2009, at B1 ("Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision. A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.")
6. Letter from H. Thomas Wells, Jr., President, Am. Bar Ass'n, to Rep. Frank Pallone, Jr., Chairman, Subcomm. on Health, Comm. on Energy & Commerce, U.S. House of Representatives (Dec. 29, 2008), available at http://www.abanet.org/poladv/letters/tortlaw/2008dec29_medicaldeviceh_l.pdf (urging the sponsor of H.R. 6381 to reintroduce it in the next Congress).
7. See infra Part I.A.1.
8. Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49,603 (Aug. 22, 2008) (to be codified at 21 C.F.R. pts. 314, 601, 814).
9. E.g., Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach, 76 GEO. WASH. L. REV. 449, 452-53 (2008) [hereinafter Sharkey, Products Liability Preemption].
10. Id. at 477-502.
11. See id. at 520.
12. Wyeth v. Levine, 129 S. Ct. 1187, 1201 (2009). Wyeth stands as a prominent example of an indirect challenge to an agency regulation-in this case, the FDA's preemption preamble-with dire consequences for the defendant manufacturer. For discussion, see infra notes 247-52 and accompanying text.
13. Wyeth, 129 S. Ct. at 1201.
14. Catherine M. Sharkey, Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, 56 Depaul L. Rev. 227, 228 (2007) [hereinafter Sharkey, Preemption by Preamble].
15. Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels, 65 Fed. Reg. 81,082, 81,103 (proposed Dec. 22, 2000).
16. For a full discussion of Executive Order 13,132, see infra notes 122-27 and accompanying text
17. Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922, 3934 (Jan. 24, 2006) (codified at 21 C.F.R. pts. 201, 314, 601) ("FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.").
18. The main thrust of the FDA's federalism impact statement (FIS) was that the FDA had authority to preempt state law in this area. Id. at 3967-69. According to the FDA, "[i]f State authorities, including judges and juries applying State law, were permitted to reach conclusions about the safety and effectiveness [of labels]. .. the federal system for regulation of drugs would be disrupted." Id. at 3969. The FDA acknowledged its obligation under Executive Order 13,132 to preempt state law as minimally as possible, but claimed that "[t]his final rule meets the preceding requirement because. .. it preempts state law only to the extent required to preserve Federal interests." Id.
19. Id. at 3969.
20. Brief of the National Conference of State Legislatures as Amicus Curiae Supporting Respondents at 9-10, Wyeth v. Levine, 129 S. Ct. 1187 (2009) (No. 06-1249), 2008 WL 3851606.
21. Id. at 10 (quoting the Affidavit of Susan Parnas Frederick).
22. Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority?: Hearing Before the S. Comm. on the Judiciary, 110th Cong. 144 (2007) [hereinafter Sen. Hearing on Regulatory Preemption] (statement of Donna D. Stone, President, National Conference of State Legislatures), available at http://judiciary.senate.gov/hearings/testimony.cfm?id=2935&wit_id=6641. Stone further charged that "during this rule's 5-year dormancy period, the FDA had allowed certain large pharmaceutical companies to submit comments pertaining to preemption after the expiration of the comment period." Id. at 144-45.
23. Letter from Ill. State Senator Steven J. Rauschenberger, President, Nat'l Conference of State Legislatures, to Michael O. Leavitt, Sec'y, U.S. Dep't Health & Human Servs. (Jan. 13, 2006) (emphasis omitted), available at http://www.ncsl.org/programs/press/2006/060113Leavitt.htm. The letter also sharply criticized the FDA's justification of its action: NCSL understands that FDA now intends to finalize this rule and include a policy statement that provisions of the Labeling Rule would now preempt state product liability laws. NCSL recently asked FDA officials why it was including this harmful language. References to several recent court cases wherein FDA filed amicus briefs and in which FDA's position on federal preemption of state laws did not prevail were offered. FDA further informed NCSL it would not re-publish the Labeling Rule and open it up for comments based on this very significant change, nor would it share the proposed language with NCSL. Id.
24. Letter from Representative Henry A. Waxman et al., to Michael O. Leavitt, Sec'y, U.S. Dep't Health & Human Servs. (Feb. 23, 2006), available at http://dodd.senate.gov/index.php?q=node/3381.
25. see also Letter from Edward M. Kennedy & Christopher J. Dodd, Senators, U.S. Senate, to Michael O. Leavitt, Sec'y, U.S. Dep't Health & Human Servs. (Feb. 23, 2006), available at http://dodd.senate.gov/index.php?q=node/3381 ("We strongly believe that states have an important role to play in protecting consumers and patients from unsafe drugs, and question the notion that the FDA alone can provide this protection.").
26. The proposed regulation was published in the Federal Register on January 16, 2008, the FDA solicited comments, and the final rule was published on August 22, 2008 (effective September 22, 2008). Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49,603 (Aug. 22, 2008) (to be codified at 21 C.F.R. pts. 314, 601, 814).
27. Id. at 49,603-04.
28. Id. at 49,604. "Newly acquired information" is defined in the final rule as "data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA." Id. at 49,609.
29. Id. at 49,605 (quoting Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922, 3935 (Jan. 24, 2006) (to be codified at 21 CFR pts. 201, 314, 601) (drug labeling preemption preamble)).
30. Id. at 49,605-06; see also Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. at 3935 ("State-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product's risks, thereby potentially discouraging safe and effective use of approved products. .. .").
31. Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. at 49,604-05 ("FDA received approximately 20 comments to the January 2008 proposed rule.").
32. See, e.g., Letter from Henry A. Waxman, Chairman, House Comm. on Oversight & Gov't Reform, to Andrew C. von Eschenbach, Comm'r, FDA 1 (Jan. 23, 2008) [hereinafter Waxman Letter], available at http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480401a97&disposition=attachment&contentType=pdf (claiming the CBE rule was not "an isolated case, but part of a pattern of actions in the Bush Administration's final months to permanently insulate the drug and device industry from liability"). The letter was cosigned by a number of other congressmen, including Senator Edward M. Kennedy, Chairman of the Senate Committee on Health, Education, Labor, and Pensions. Id. at 6
33. see also Letter from Ronald Goldman, Esquire, Baum, Hedlund, Aristei & Goldman, to Div. of Dockets Mgmt., FDA 6 (Mar. 17, 2008), available at http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064803ff31e&disposition=attachment&contentType=pdf ("[S]ince the arrival of the Bush administration, FDA policy-makers seem to have forgotten the FDA's objectives and obligations. Rather, the agency appears to be more concerned with protecting the profits of the pharmaceutical industry.")
34. Letter from Peter Lurie, Deputy Dir., & Sydney M. Wolfe, Dir. of Health Research, Public Citizen, to Div. of Dockets Mgmt., FDA 3 (Mar. 17, 2008), available at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-N-0032 (noting that the FDA's propreemption policy stance emerged only in the last few years).
35. Letter from Bart Stupak et al., U.S. House of Reps., to Andrew C. von Eschenbach, Comm'r, FDA 1 (Feb. 29, 2008) [hereinafter House of Representatives Letter], available at http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480401990&disposition=attachment&contentType=pdf; see also Letter from Kathleen Flynn Peterson, President, Am. Ass'n for Justice, to Div. of Dockets Mgmt., FDA 3 (Mar. 17, 2008), available at http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064803fab4b&disposition=attachment&contentType=pdf (claiming that the FDA's proposal would limit dissemination of risk information "at a time when every independent evaluation has shown that the FDA is woefully incapable of acting timely to provide this information"); Waxman Letter, supra note 30, at 1 (questioning whether an agency would spend its already-strapped resources to promulgate a rule "that will serve only to deprive American consumers of critically important and timely information").
36. House of Representatives Letter, supra note 31, at 1-2.
37. Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49,603, 49,609 (Aug. 22, 2008) (to be codified at 21 C.F.R. pts. 314, 601, 814) ("FDA issued a 'Dear Colleague' letter. ... [t]he purpose of [which] was to alert officials in various organizations within the fifty States about the rulemaking, including officials with State pharmacy boards, State medical boards, health commissioners, and drug program directors.").
38. Letter from Jean Hoeffer Toal, President, Conf. of Chief Justices, to Div. of Docket Mgmt., FDA 1 (Mar. 17, 2008), available at http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064803ff415&disposition=attachment&contentType=pdf.
39. Id. at 2.
40. Id. at 3.
41. Here, I put to one side the fact that the FDA's decision to amend the CBE regulation seemed motivated by a desire to affect pending litigation in Wyeth v. Levine, 129 S. Ct. 1187 (2009). The FDA cited the U.S. government's amicus brief in Wyeth twice in promulgating its final rule. See Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. at 49,605-06. In Wyeth, the Solicitor General argued for a rule preempting any state law claims that "challenge labeling that FDA approved after being informed of the relevant risk." Id. at 49,606 (quoting Brief for the United States as Amicus Curiae Supporting Petitioner at 7, Wyeth v. Levine, 129 S. Ct. 1187 (2009) (No. 06-1249), 2008 WL 2308908).
42. Nina A. Mendelson, Chevron and Preemption, 102 Mich. L. Rev. 737, 783-84 (2004).
43. Id. at 783-84. Mendelson's figure is taken from H.R. 2245, The Federalism Act of 1999: Hearing Before the Subcomm. on Nat'l Econ. Growth, Natural Res., and Regulatory Affairs of the H. Comm. on Gov't Reform, 106th Cong. 101 (1999) (statement of Nye Stevens, Director, Federal Management and Workforce Issues, General Government Division, General Accounting Office).
44. Mendelson, supra note 39, at 784 n.192.
45. Id. at 783. Mendelson performed the following search: "Executive Order 13132" and not (%) ((no or not) /s federalism). Id. at 783 n.191. She then examined the remaining rules individually and found five that included an FIS of some sort and one which claimed an FIS would be available if requested. Id.
46. Id. at 783.
47. Id. at 784.
48. Id. ("Only one of the five [FISs]. .. even acknowledged the interests of states in protecting their in-state residents. .. .").
49. In a further study, Mendelson turned up six rules or proposed rules with preemptive effects in 2006. Of these, only three concluded that FISs were required, and only a single FIS was substantive. Nina A. Mendelson, A Presumption Against Agency Preemption, 102 Nw. U. L. Rev. 695, 719 (2008).
50. Id. at 720-21.
51. I am grateful to journalist Pete Yost of the Associated Press for providing me with a list of proposed and final rules containing preemption provisions-issued by the FDA, NHTSA, CPSC, Federal Railroad Administration, and Department of Homeland Security-which was a useful starting point for my research. See E-mail from Pete Yost to Catherine Sharkey, Professor of Law, New York Univ. Sch. of Law (May 5, 2008, 12:31 EST) (on file with Duke Law Journal).
52. Food Labeling: Health Claims; Soluble Dietary Fiber from Certain Foods and Coronary Heart Disease, 70 Fed. Reg. 76,150, 76,161 (interim final rule Dec. 23, 2005).
53. Food Labeling: Health Claims; Soluble Dietary Fiber from Certain Foods and Coronary Heart Disease, 71 Fed. Reg. 29,248, 29,250 (May 22, 2006) (codified at 21 C.F.R. pt. 101).
54. Compare Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph, 68 Fed. Reg. 46,133, 46,137 (proposed Aug. 5, 2003) (to be codified at 21 C.F.R. pts. 310, 334) (stating that the proposal did not contain policies that would affect the federal-state balance), with Laxative Drug Products for Over-the-Counter Human Use; Psyllium Ingredients in Granular Dosage Forms, 72 Fed. Reg. 14,669, 14,673 (Mar. 29, 2007) (codified at 21 C.F.R. pts. 201, 310) (asserting that the agency's policy decision carried preemptive effect); compare Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products, 69 Fed. Reg. 21,778, 21,792 (proposed Apr. 22, 2004) (to be codified at 21 C.F.R. pts. 201, 208, 209) (stating that the rule would not alter the federal-state balance), with Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products, 73 Fed. Reg. 63,886, 63,896 (Oct. 28, 2008) (to be codified at 21 C.F.R. pts. 201, 208, 209) (stating that the rule preempts state law); compare Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Proposed Amendment to the Monograph, 70 Fed. Reg. 73,178, 73,180 (proposed Dec. 9, 2005) (to be codified at 21 C.F.R. pts. 310, 358) (stating that the proposal did not have federalism implications), with Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Amendment to the Monograph, 72 Fed. Reg. 9849, 9851 (Mar. 6, 2007) (codified at 21 C.F.R. pts. 310, 358) (stating that the rule would preempt state law).
55. Compare Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim "Lean," 70 Fed. Reg. 71,041, 71,056 (proposed Nov. 25, 2005) (to be codified at 21 C.F.R. pt. 101) (stating that the rule "does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power" and "tentatively conclud[ing] that the rule [did] not contain policies that have federalism implications," thus negating the need for a federalism impact statement), with Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim "Lean," 72 Fed. Reg. 1455, 1459 (Jan. 12, 2007) (codified at 21 C.F.R. pt. 101) (prohibiting states from "promulgating any nutrient content claim labeling requirements for the claim 'lean' that are not identical" to those in the final rule); compare Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling, 68 Fed. Reg. 2254, 2261 (proposed Jan. 16., 2003) (to be codified at 21 C.F.R. pt. 201) (stating that the FDA "tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order [13,132]"), with Over-the-Counter Vaginal Contraceptive and Spermicide Drug Products Containing Nonoxynol 9; Required Labeling, 72 Fed. Reg. 71,769, 71,783-84 (Dec. 19, 2007) (codified at 21 C.F.R. pt. 201) (asserting preemptive effect using boilerplate language); compare Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Monograph for Over-the-Counter Nasal Decongestant Drug Products, 69 Fed. Reg. 63,482, 63,486 (proposed Nov. 2, 2004) (noting that the FDA "tentatively conclude[d] that the proposed rule [did] not contain policies that have federalism implications"), with Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products, 71 Fed. Reg. 43,358, 43,361 (Aug. 1, 2006) (codified at 21 C.F.R. pt. 341) (claiming preemption). In each of these cases, in the final rule, the FDA relies almost exclusively on the express preemption provisions of the FDCA pertaining to foods and overthe-counter drugs, respectively, 21 U.S.C. § 343-1 (2006) and 21 U.S.C. § 379r (2006). But even if that authority were airtight, it would still beg the question of why the FDA's earlier conclusions published in the proposed rules were only "tentative."
56. Federal Motor Vehicle Safety Standards; Head Restraints, 72 Fed. Reg. 25,484, 25,512 (May 4, 2007) (to be codified at 49 C.F.R. pts. 571, 585).
57. Federal Motor Vehicle Safety Standards; Head Restraints, 69 Fed. Reg. 74,848, 74,880 (Dec. 14, 2004) (codified at 49 C.F.R. pt. 571).
58. Federal Motor Vehicle Safety Standards; Head Restraints, 72 Fed. Reg. at 25,512. Further, the record displays no opportunity for comment on this point, nor does it indicate that the agency had disclosed its preemptive intent at any time prior to the final rule. See id. ("[N]o consultation is needed to discuss the preemptive effect of today's rule.").
59. Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000).
60. Id. at 867-69. Nor does NHTSA's add-on to the effect that "the Supreme Court has also recognized that State requirements. .. can stand as an obstacle to the accomplishment and execution of a NHTSA safety standard" rehabilitate NHTSA's stance. Federal Motor Vehicle Safety Standards; Head Restraints, 72 Fed. Reg. at 25,512 (citing Geier, 529 U.S. 861).
61. Geier, 529 U.S. at 867-68.
62. See, e.g., Federal Motor Vehicle Safety Standards; Occupant Crash Protection in Interior Impact, 72 Fed. Reg. 50,900, 50,905 (Sept. 5, 2007) (to be codified at 49 C.F.R. pt. 571) ("NHTSA has examined today's final rule pursuant to Executive Order 13132. .. and concluded that no additional consultation with States, local governments or their representatives is mandated beyond the rulemaking process. The agency has concluded that the rulemaking would not have federalism implications because a final rule, if issued, would not have 'substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.' Further, no consultation is needed to discuss the preemptive effect of today's rulemaking." (quoting Exec. Order No. 13,132, 64 Fed. Reg. 43,255, 43,255 (Aug. 4, 1999))). In the notice of proposed rulemaking, NHTSA stated that the rule "would not have any substantial impact on the States, or on the current Federal-State relationship," and that consultation with the states was not required. Federal Motor Vehicle Safety Standards; Occupant Protection in Interior Impact, 71 Fed. Reg. 20,932, 20,939-40 (proposed Apr. 24, 2006) (to be codified at 49 C.F.R. pt. 571). In the final rule, NHTSA also expressly reserved for itself the opportunity to comment on specific instances of preemption down the road. Federal Motor Vehicle Safety Standards; Occupant Crash Protection in Interior Impact, 72 Fed. Reg. at 50,905.
63. Federal Motor Vehicle Safety Standards; Cargo Carrying Capacity, 72 Fed. Reg. 68,442, 68,458 (Dec. 4, 2007) (to be codified at 49 C.F.R. pt. 571).
64. Federal Motor Vehicle Safety Standards; Cargo Carrying Capacity, 70 Fed. Reg. 51,707, 51,713-14 (proposed Aug. 31, 2005) (to be codified at 49 C.F.R. pt. 571).
65. Brief of Amicus Curiae Constitutional and Administrative Law Scholars in Support of Respondent at 32, Wyeth v. Levine, 129 S. Ct. 1187 (2009) (No. 06-1249), 2008 WL 3851604.
66. Brief of Amici Curiae Vermont et al. in Support of Respondent at 25, Wyeth, 129 S. Ct. 1187 (No. 06-1249), 2008 WL 3851613 [hereinafter States' Wyeth Amicus Brief].
67. Herbert Wechsler, The Political Safeguards of Federalism: The Role of the States in the Composition and Selection of National Government, 54 Colum. L. Rev. 543 (1954).
68. Brief of Torts Professors Mark P. Gergen and Michael D. Green as Amici Curiae in Support of Respondent at 33, Wyeth, 129 S. Ct. 1187 (No. 06-1249), 2008 WL 3851610.
69. Wechsler, supra note 67.
70. Id. at 548.
71. Id. at 546 (emphasis omitted).
72. Id. at 547. According to Wechsler, in both houses of Congress, "the states are the strategic yardsticks for the measurement of interest and opinion, the special centers of political activity, the separate geographical determinants of national as well as local politics." Id. at 546.
73. Larry Kramer, for example, argues that the safeguards of federalism are secured by political parties, not the structure of the electoral process. Larry D. Kramer, Putting the Politics Back into the Political Safeguards of Federalism, 100 COLUM. L. REV. 215, 215 (2000). According to Kramer, political parties are characterized by being neither programmatic nor centralized. Id. at 278-79. National politicians, therefore, often rely heavily on local and state politicians for getting out the vote and for other electoral benefits. See id. at 279 (describing America's "political culture in which members of local, state, and national networks are encouraged, indeed expected, to work for election of candidates at every level" that encourages "mutual dependency among party and elected officials at different levels"). In addition, political parties are the mechanism by which politicians translate their local and state experience to a national platform. See id. at 285 ("Fully half of the members of the House of Representatives, for example, began their careers as state legislators, and men and women recruited and trained at the state level are found throughout the federal bureaucracy."). In other words, Kramer substitutes the forces of localized political parties for the disciplining force of the electoral process of Wechsler's model.
74. See, e.g., Geier v. Am. Honda Motor Co., 529 U.S. 861, 907 (2000) (Stevens, J., dissenting) ("The signal virtues of this presumption [against preemption include] its placement of the power of pre-emption squarely in the hands of Congress, which is far more suited. .. to strike the appropriate state/federal balance (particularly in areas of traditional state regulation). .. .")
75. Mendelson, supra note 39, at 768 ("[T]he fact that members of Congress come from particular districts and states probably does give them a particular incentive to focus on state interests that have especially regional aspects.")
76. Mark D. Rosen, Contextualizing Preemption, 102 Nw. U. L. Rev. 781, 797 (2008) ("[W]hether state law should be preempted is best characterized as a subjective 'political' decision that is most appropriately made by Congress, the most politically representative branch.")
77. Peter J. Smith, Pennhurst, Chevron, and the Spending Power, 110 Yale L.J. 1187, 1202 (2001) (arguing that the reliance on state voter support makes federal congressional representatives, "whom the voters may remove from office if they fail adequately to respect state prerogatives," accountable to the states in federalism determinations); Ernest A. Young, Two Cheers for Process Federalism, 46 Vill. L. Rev. 1349, 1385 (2001) (asserting that the presumption against preemption protects federalism by "forc[ing] Congress to make a deliberative political decision about how far it wants to intrude on state autonomy, and. .. mak[ing] sure that all the states' potential defenders have notice of what is at stake," and by "reinforc[ing] institutional checks by requiring Congress to make the decision, with all the procedural hurdles and roadblocks that process entails").
78. In this vein, Kramer has challenged "those who would persist in defending judicial intervention. .. to explain why institutional arrangements that have worked for more than two centuries have suddenly ceased to do so." Kramer, supra note 73, at 290.
79. For such an argument in a different field, see Peter H. Schuck & John Williams, Removing Criminal Aliens: The Pitfalls and Promises of Federalism, 22 Harv. J.L. & Pub. Pol'y 367, 422-54 (1999).
80. Roderick M. Hills, Jr., Against Preemption: How Federalism Can Improve the National Legislative Process, 82 N.Y.U. L. Rev. 1, 10 (2007) (quoting Vincent Ostrom, Robert Bish & Elinor Ostrom, Local Government in the United STATES 97-98 (1988)). Hills argues that a large and politically diverse body can be prone to counterproductive gridlock on important issues. Id. at 10-16.
81. See id. at 1 (arguing that "an anti-preemption rule of statutory construction has benefits for the national lawmaking process"). But see Sharkey, Preemption by Preamble, supra note 11, at 255 n.140 ("As a theoretical matter. .. one could employ either a strong pro- or antipreemption default (or presumption) for court decisionmaking.. .. Ultimately, it is an empirical claim whether one or the other default position would lead to greater mobilization of the public, leading to some congressional action."); Sharkey, Products Liability Preemption, supra note 6, at 450-51 n.4 ("While Hills's account might explain issues that fail to reach the congressional agenda, such as bills that die in committee, it has far less explanatory power in the situation-dominant in products liability preemption-where the issue is squarely before Congress (on a repeat basis no less) and Congress manages to speak out of both sides of its mouth. Instead, it seems more plausible that Congress affirmatively punts the issue to courts and/or agencies.").
82. Hills, supra note 77, at 28; see also Einer Elhauge, Statutory Default Rules: How to Interpret Unclear Legislation 152-53 (2008) (advocating for the use of "preference-eliciting default rules")
83. Young, supra note 74, at 1361-62 (citing Bradford R. Clark, Federal Common Law: A Structural Reinterpretation, 144 U. PA. L. Rev. 1245, 1261 (1996))
84. Constitutional Compromise and the Supremacy Clause
85. See, e.g., Hills, supra note 77, at 28-36 (arguing in favor of a "presumption against preemption" to force Congress to act by mobilizing business groups to lobby Congress to act, leading to a robust national debate of preemption issues); Young, supra note 74, at 1389 (arguing that "resistance norms" such as requiring a clear statement rule before countenancing preemption will force Congress to debate what exactly is at stake, giving notice to those impacted); see also Mendelson, supra note 46, at 710 (making the point that requiring Congress to get involved will mitigate the risk that federalism interests would be eviscerated incidentally).
86. Mendelson, supra note 46, at 717.
87. Id. at 717-18; see also Mendelson, supra note 39, at 787-89 (arguing that agencies are not well equipped to evaluate the overall distribution of governmental authority as compared to Congress and the Judiciary); Robert R.M. Verchick & Nina Mendelson, Preemption and Theories of Federalism, in Preemption Choice 13, 27 (William W. Buzbee ed., 2009) ("[A]gencies lack the expertise to evaluate the federal-state balance. .. .").
88. Cass R. Sunstein, Nondelegation Canons, 67 U. CHI. L. REV. 315, 338 (2000). Sunstein also points out that "certain decisions are ordinarily expected to be made by the national legislature, with its various institutional safeguards, and not via the executive alone." Id. at 343
89. see also Lisa Schultz Bressman, Deference and Democracy, 75 GEO. Wash. L. Rev. 761, 765 (2007) (suggesting that courts should not defer to agencies for "extraordinary questions").
90. See Mendelson, supra note 39, at 782; see also id. at 741 ("Federalism values, such as ensuring core state regulatory authority and autonomy, are important and can be protected through political processes.").
91. Brief of the Center for State Enforcement of Antitrust and Consumer Protection Laws, Inc. as Amicus Curiae in Support of Respondent at 23, Wyeth v. Levine, 129 S. Ct. 1187 (2009) (No. 06-1249), 2008 WL 3851615.
92. Sharkey, Products Liability Preemption, supra note 6, at 450-51 n.4.
93. Id. at 450. Nor is there reason to be sanguine about the possibility that Congress, though initially ambiguous, will react more decisively following judicial decisions. See Note, New Evidence on the Presumption Against Preemption: An Empirical Study of Congressional Responses to Supreme Court Preemption Decisions, 120 Harv. L. Rev. 1604, 1612-13 (2007) (examining congressional responses to Supreme Court preemption decisions between 1983 and 2003 and finding that, of 127 Court cases pertaining to preemption of state law, Congress overruled only two of the decisions, and partially overruled a third). Whereas relatively unexplored (with a few notable exceptions) in the legal literature, congressional inaction, or calculated ambiguity, is a subject of robust discussion in the political science literature.
94. See, e.g., Daryl J. Levinson & Richard H. Pildes, Separation of Parties, Not Powers, 119 Harv. L. Rev. 2312, 2353-54 (2006) (describing how political parties encourage Congress to abstain from action when both the executive and legislative branches are controlled by the same party); Richard H. Pildes, Political Avoidance, Constitutional Theory, and the VRA, 117 Yale l.J. Pocket Part 148 (2007), http://thepocketpart.org/2007/12/10/pildes.html (arguing that reauthorization of the Voting Rights Act in 2006 was a prime example of congressional abdication); see also Morris P. Fiorina, Legislative Choice of Regulatory Forms: Legal Process or Administrative Process?, 39 Pub. Choice 33, 47 (1982) (examining congressional incentives to delegate decisionmaking power to agencies and noting that, under the "shift the responsibility model," "[b]y charging an agency with the implementation of a general regulatory mandate, legislators. .. avoid or at least disguise their responsibility for the consequences of the decisions ultimately made" (internal quotation marks omitted))
95. Kenneth A. Shepsle, The Strategy of Ambiguity: Uncertainty and Electoral Competition, 66 Am. Pol. Sci. Rev. 555, 567 (1972) (analyzing the argument that politicians are most likely to retain voter support by adopting equivocal platforms, and concluding that that theory may be true only when "a majority of voters is risk-acceptant (and. .. possesses intense preferences, thus rendering the issue 'critical')").
96. See Minority Staff of H. Comm. on Gov't Reform, Special Investigations DIV., 109th Cong., Congressional Preemption of State Laws and Regulations 17-38 (2006) (describing preemption provisions Congress has added to twenty-seven laws since 2001). The vast majority of the provisions cited in the survey simply provide absolute preemption of state action or common law. See, e.g., Law Enforcement Officers Safety Act of 2004, 18 U.S.C. §§ 926B-C (2006) (preempting concealed weapons laws for former and off-duty law enforcement officers); Public Readiness and Emergency Preparedness Act, 42 U.S.C. § 247d-6d (2006) (providing full immunity for producers of certain vaccines); Consolidated Appropriations Act, 2004, Pub. L. No. 108-199, 118 Stat. 418 (preempting certain standards for limiting pollution from small engines).
97. David Shapiro kindly supplied several early uses of the quip: The Book of Psalms: "Lord grant me the wisdom not to use a sledgehammer when the task bespeaketh the need of a scalpel." Hamlet to Polonius: "I can tell a sledgehammer from a scalpel when the wind is north, northwest." Hart & Wechsler's First Edition: "It is clear, is it not, that the occasion calls not for a sledgehammer but a scalpel?" E-mail from David Shapiro, William Nelson Cromwell Professor of Law Emeritus, Harvard Law Sch., to Catherine Sharkey, Professor of Law, New York Univ. Sch. of Law (Feb. 13, 2009, 15:11 EST) (on file with Duke Law Journal).
98. See, e.g., Medical Device Safety Act of 2008, S. 3398, 110th Cong. (2008) (explaining the proposed "savings clause" to overturn Riegel preemption for medical devices).
99. Cf. Peter Huber, Safety and the Second Best: The Hazards of Public Risk Management in the Courts, 85 Colum. L. Rev. 277, 334 (1985) ("Administrative agencies may find it politically convenient to disclaim final responsibility for [their] public risk choices. .. .")
100. Lars Noah, Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability, 88 Geo. L.J. 2147, 2158 (2000) (discussing the historic practice of the FDA not to oppose judicial review of agency standards because the tort system served as a convenient "'safety valve' for deflecting adverse publicity" when FDA-approved products were subsequently demonstrated to be defective).
101. See Lynn A. Baker, Putting the Safeguards Back into the Political Safeguards of Federalism, 46 Vill. L. Rev. 951, 956-61 (2001) (detailing the congressional interests in expanding federal power)
102. Lynn A. Baker & Ernest A. Young, Federalism and the Double Standard of Judicial Review, 51 Duke L.J. 75, 113-14 (2001) (arguing that congressional representatives may be hostile to state regulatory interests because federal representatives compete with state politicians for support from their shared constituency and "any official seeking to maximize his own support would seek to maximize his own [federal] regulatory jurisdiction at the expense of other [state] public officials seeking support from the same constituents").
103. See Brian Galle & Mark Seidenfeld, Administrative Law's Federalism: Preemption, Delegation, and Agencies at the Edge of Federal Power, 57 DUKE L.J. 1933, 1971 (2008) ("Agencies have the potential to be both deliberative and responsive to political preferences, both because of their relationship to the courts and the political branches and because of their composition and the motivation of their staff members."). Agency officials may have relevant backgrounds for taking state actors' concerns seriously. Agency officials may also have worked with or in state government, providing them with a state-side perspective of relevant regulatory issues. See id. at 1975 ("[T]o satisfy judicial review, agencies need staff members from a multitude of professions who can understand the views of all greatly affected interest groups.").
104. Real ID Act of 2005, Pub. L. No. 109-13, 119 Stat. 302 (codified in scattered sections of 8 and 49 U.S.C. (2006)).
105. 49 U.S.C. § 30301 note (2006) (Improved Security Requirements for Drivers' Licenses and Personal Identification Cards).
106. Id. ("All authority to issue regulations, set standards, and issue grants under this title shall be carried out by the Secretary, in consultation with the Secretary of Transportation and the States." (emphasis added)). A prior statute (which the 2005 Act replaced) had instead required a negotiated rulemaking procedure.
107. See id.
108. Minimum Standards for Driver's Licenses and Identification Cards Acceptable by Federal Agencies for Official Purposes, 73 Fed. Reg. 5272, 5329-30 (Jan. 29, 2008) (to be codified at 6 C.F.R. pt. 37).
109. Id. at 5330.
110. The transcript is available online at Regulations.gov. U.S. Dep't of Homeland Security, DHS-2006-0030-1839, Real Id Negotiated Rulemaking Comment Session (2007), available at http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648023072e.
111. See Nat'l Conference of State Legislatures, Count Down to Real ID, http://www.ncsl.org/RealID/ (last visited Mar. 7, 2009) (counting down to the date REAL ID becomes effective and providing a number of resources detailing state opposition to the law).
112. Sen. Hearing on Regulatory Preemption, supra note 21, at 148-49 (statement of Donna Stone, President, National Conference of State Legislatures).
113. Letter from Governors Tim Pawlenty & Edward G. Rendell to Senator Harry Reid, Majority Leader, U.S. Senate, et al. (Mar. 20, 2008), available at http://www.nga.org/portal/site/nga/menuitem.cb6e7818b34088d18a278110501010a0/?vgnextoid=e9986c653ecc8110VgnVCM1000001a01010aRCRD. The governors did, however, voice criticisms of Congress: Governors supported initial legislation to enhance driver's licenses through a cooperative negotiated rulemaking. When that legislation was repealed and replaced with REAL ID, governors objected and called on the Department of Homeland Security (DHS) and Congress to fix and fund REAL ID by fashioning reasonable rules and providing adequate funding to cover the cost of this new national mandate.. .. Now, if REAL ID is to become a reality, Congress and the Administration must provide sufficient funding to cover states' cost[s] and preserve flexibility for states to manage their unique systems. Id. That sizeable costs are imposed on the states is a significant issue. A study conducted by the NCSL, NGA, and the American Association of Motor Vehicle Administrators estimates that the cost to the states will exceed eleven billion dollars. Nat'l Governor's Ass'n, Nat'l Conference Of State Legislatures & Am. Ass'n of Motor Vehicle Mfrs., the Real id Act: National Impact Analysis 3 (2006), http://www.ncsl.org/print/statefed/Real_ID_Impact_Report_FINAL_Sept19.pdf.
114. Nat'l Conference of State Legislatures, The History of Federal Requirements for State Issued Driver's Licenses and Identification Cards, http://www.ncsl.org/standcomm/sctran/History_of_DL_Reform.htm (last visited Mar. 19, 2009)
115. see also Understanding the Realities of REAL ID: A Review of Efforts to Secure Drivers' Licenses and Identification Cards: Hearing Before the Subcomm. on Oversight of Government Management, the Federal Workforce, & the District of Columbia of the S. Comm. on Homeland Security and Governmental Affairs, 110th Cong. 22 (2007), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_senate_hearings&docid=f:34415.pdf (statement of Leticia Van de Putte, President, National Conference of State Legislatures, and State Senator, Texas) ("NCSL acknowledges that the draft regulations incorporate a number of our recommendations made in the September 2006 report.").
116. Sharkey, Products Liability Preemption, supra note 6, at 477.
117. Id. at 485.
118. Sharkey, Preemption by Preamble, supra note 11, at 252, 252-53 (sketching out a "federalism-inspired" model for agency participation in preemption decisions, based upon a "federal-state dialogue" pursuant to congressional and executive agency mandates to consult with state and local authorities)
119. See, e.g., Peter H. Schuck, Delegation and Democracy: Comments on David Schoenbrod, 20 Cardozo L. Rev. 775, 781-90 (1999) (arguing that agencies are superior venues for accountability in a number of important respects). Scholars-perhaps most prominently Cass Sunstein-have previously argued that the courts and Congress play essential roles in guiding and ensuring accountability on the part of agencies.
120. See, e.g., Cass R. Sunstein, Changing Conceptions of Administration, 1987 Byu l. Rev. 927, 941 (Congress is capable of providing "relatively clear guidelines" that ensure that agencies remain accountable and that "statutes [will not] be defeated in the implementation process"); Cass R. Sunstein, Factions, Self-Interest and the APA: Four Lessons Since 1946, 72 Va. L. Rev. 271, 272-77 (1986) (arguing that, since the passage of the Administrative Procedure Act, courts have taken advantage of an improved understanding of the purposes of regulation and the function of agencies to monitor and prod agencies in the direction of efficiency, effectiveness, and accountability)
121. Cass R. Sunstein, Law and Administration After Chevron, 90 Colum. L. Rev. 2071, 2110-12 (1990) (embracing courts' use of "[c]lear statement" Rules designed, as a quasi substitute for the nondelegation doctrine, either to ensure clear congressional statements on issues that have constitutional dimensions or to ensure that Congress deliberates on the issue).
122. Galle & Seidenfeld, supra note 94, at 1948-83. Mark Seidenfeld has long been an advocate of broad delegations of authority to agencies. See, e.g., Mark Seidenfeld, A Civic Republican Justification for the Bureaucratic State, 105 HARV. L. REV. 1511, 1551 (1992) ("I believe that civic republicanism provides a strong justification for the assignment of broad policymaking discretion to administrative agencies.").
123. Galle & Seidenfeld, supra note 94, at 1949-61.
124. Id. at 1962.
125. Id. at 1962-68.
126. Id. at 1971-79.
127. Id. at 1979-84.
128. Id. at 1980 n.194 (describing how voters' information is imperfect, causing legislators' positions to differ substantially from their constituents' preferences on any particular issue).
129. Id. at 1980-84 (generally describing the various mechanisms of executive and legislative control of agencies); see also Elena Kagan, Presidential Administration, 114 Harv. L. Rev. 2245, 2284-303 (2001) (describing three techniques of presidential control: "review," "directives," and "appropriation"); Charles Tiefer, Congressional Oversight of the Clinton Administration and Congressional Procedure, 50 Admin. L. Rev. 199, 205-15 (1998) (describing congressional controls over agencies including: Senate floor procedures, committee jurisdictions, appropriation procedures, and the congressional budget process).
130. Gillian E. Metzger, Administrative Law as the New Federalism, 57 Duke L.J. 2023, 2080-81 (2008).
131. This is a frequent claim in the legal literature. See, e.g., Einer Elhauge, Preference-Estimating Statutory Default Rules, 102 Colum. L. Rev. 2027, 2127 (2002) ("[A]gencies have certain biases (such as a bias in favor of expanding their power) that might distort their interpretations [of vague statutory delegations]."); Thomas W. Merrill, Preemption and Institutional Choice, 102 Nw. U. L. Rev. 727, 756 (2008) ("Not every agency is bent on empire building or is captured by the firms it regulates. But these phenomena are not unheard of and warrant caution before automatically deferring to agency judgments about the need for preemption. Agencies may also resent the implicit competition from other sources of regulatory authority like states."); Rosen, supra note 74, at 801-02 ("[T]here are good reasons to be skeptical of a bureaucracy's decision regarding its own powers."). But the claim of agency self-aggrandizement stands empirically on shaky ground; moreover, it does not appear to hold even in the preemption context.
132. See, e.g., Sharkey, Products Liability Preemption, supra note 6, at 475 ("Counterintuitively, federal agencies have been just as likely, if not more likely, to argue against preemption in the products liability realm."); id. at 475-77, 486-90 (discussing numerous examples)
133. see also Daryl J. Levinson, Empire-Building Government in Constitutional Law, 118 Harv. L. Rev. 915, 932-34 (2005) (pointing to a litany of scholarship that suggests that agency bureaucrats do not necessarily try to expand their own power but are rather controlled by a combination of self-interest, professionalism, and political oversight); Metzger, supra note 118, at 2078-79 ("Too many instances exist of federal agencies refusing to preempt or seeking to expand state regulatory autonomy to conclude that federal agencies are categorically insensitive or hostile to preserving a state regulatory role." (citing Michael S. Greve & Jonathan Klick, Preemption in the Rehnquist Court: A Preliminary Empirical Assessment, 14 Supreme CT. Econ. Rev. 43, 73 (2006))
134. Greve & Klick, supra, at 73 (observing that, during the Rehnquist Court, the Solicitor General took "a pro-preemption position in [only] 39 of 95 preemption cases, or about 40 percent.").
135. Metzger, supra note 118, at 2082
136. See Sharkey, Products Liability Preemption, supra note 6, at 477-502
137. Catherine M. Sharkey, What Riegel Portends for FDA Preemption of State Law Products Liability Claims, 103 Nw. U. L. Rev. 437, 440-62 (2009) [hereinafter Sharkey, What Riegel Portends] (extending the agency reference model by prescribing searching judicial review of evidence taken from the FDA's regulatory record to substantiate implied preemption findings). Moreover, the United States Supreme Court (I would argue) embraced this approach in Wyeth v. Levine. See infra notes 188-90 and accompanying text.
138. Exec. Order No. 13,132, 64 Fed. Reg. 43,255, 43,255 (Aug. 4, 1999). Executive Order 13,132 applies to all agencies, save independent agencies, such as the CPSC, which nonetheless are "encouraged to comply." Independent agencies, moreover, are subject to Executive Order 12,988, signed into effect by President Clinton in February 1996, which directs agencies to "specif[y] in clear language the preemptive effect, if any, to be given to the law." Exec. Order No. 12,988, 61 Fed. Reg. 4729, 4731 (Feb. 5, 1996).
139. Exec. Order No. 13,132, 64 Fed. Reg. at 43,255.
140. Id. at 43,256. Further, section 4(a) requires agencies to "construe. .. a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute." Id. at 43,257.
141. Id. at 43,257.
142. Id. at 43,256 (stating that agencies should, "to the extent practicable," consult with state and local authorities "before any such action is implemented").
143. It may also go a long way toward explaining the absence of any models of "cooperative federalism" in this realm. Cf. Philip J. Weiser, Federal Common Law, Cooperative Federalism, and the Enforcement of the Telecom Act, 76 N.Y.U. L. Rev. 1692, 1695-703 (2001) (presenting a model whereby state agencies play a role exercising discretion within a federal regulatory regime). In other words, a precondition for such cooperative federalism is likely the existence of intricately linked state and federal agencies, with built-in incentives and opportunities for communication as well as constructive collaboration.
144. The existence of state regulatory agencies by no means assures that their resistance to preemption will be successful; the more modest point is simply that it is easier to locate the representatives of competing state interests in that context
145. For an elaboration of "the two faces of tort law," see Sharkey, Products Liability Preemption, supra note 6, at 459-71
146. The Clean Air Act, for example, requires that states establish plans to help ensure that each state implements and enforces the statute's target emissions reductions. 42 U.S.C. § 7410(a)(1) (2006). State environmental agencies enforce these policies under this statutory mandate. And under the Clean Water Act, state environmental agencies can be deputized to issue federal permits in lieu of the EPA. 42 U.S.C. § 7410(a)(2)(a) (2006)
147. see also Denise Scheberle, Federalism and Environmental Policy: Trust and the Politics of Implementation 7-10 (1997) [hereinafter Scheberle, Federalism and Environmental Policy] (describing ways that states implement federal environmental statutes); Envr. Council of States, Delegation by Environmental Act, http://www.ecos.org/section/states/enviro_actlist(last visited May 13, 2009) (noting that "[a]s of 2001, over 75% of the federal environmental programs that can be delegated have been delegated to the States" and that the Clean Air Act has been delegated by the EPA to all fifty states). Congressional mandates in the environmental regulation context set the parameters of "a matrix composed of distributed powers and necessary interdependencies," through which "state and federal actors find bargaining and negotiation standard fare." Denise Scheberle, The Evolving Matrix of Environmental Federalism and Intergovernmental Relationships, 35 Publius 69, 70 (2005) [hereinafter Scheberle, The Evolving Matrix] (citing Daniel J. Elazar, American Federalism: A View from the States (3d ed. 1984)); id. ("[T]he collaborative matrix has not disappeared but has been reconstructed by the prevalence of bargaining, growing managerial sophistication on the part of state and local actors, the opening of more venues for collaboration, and real limits on federal enforcement ability."). The EPA's internal guidelines on Executive Order 13,132 make explicit reference to this federal-state interdependence. Epa's Action Development Process, Guidance on Executive Order 13132: Federalism 21 (2008), available at http://www.govexec.com/pdfs/111908rb1.pdf (emphasizing the importance of agency consultation with state and local government officials given that "[state and local] governments carry out most of the day-to-day administration of many national environmental programs.").
148. Brian Galle, Getting Spending: How to Replace Clear Statement Rules with Clear Thinking About Conditional Grants of Federal Funds, 37 Conn. L. Rev. 155, 193 (2004)
149. see also Brian D. Galle, Can Federal Agencies Authorize Private Suits Under Section 1983?: A Theoretical Approach, 69 BROOK. L. REV. 163, 198 (2003) (describing agency-state interaction as a "collaborative enterprise between federal and state bureaucrats")
150. David Freeman Engstrom, Drawing Lines Between Chevron and Pennhurst: A Functional Analysis of the Spending Power, Federalism, and the Administrative State, 82 Tex. L. Rev. 1197, 1235-36 (2004) (arguing that federal agencies may be soliticious of state interests given that field-level administrators frequently rely on participation by state agencies and personnel).
151. But see Roderick M. Hills, Jr., The Eleventh Amendment as Curb on Bureaucratic Power, 53 Stan. L. Rev. 1225, 1227 (2001) ("The state bureaucrat cannot be trusted to lobby vigorously against federal mandates in the federal administrative process."). Hills also explains that state and federal regulators "often share more in common with each other than they do with the level of government by which they are employed." Id.
152. Another distinguishing factor may be the culture within the agency. Apparently, in the late 1990s, the EPA highlighted the executive order on federalism, assigned an ombudsman-like role to a designated federalism liaison to oversee compliance with the order, held meetings about how to deal with the executive order, and developed internal guidelines for compliance. Telephone Interview with Susan Frederick, Fed. Affairs Counsel for the Nat'l Conference of State Legislatures (July 17, 2008). In 1993, the EPA formed the State/EPA Capacity Steering Committee to improve the federal-state partnership in environmental programs.
153. See Scheberle, Federalism and Environmental Policy, supra note 131, at 13; see also Scherberle, The Evolving Matrix, supra note 131, at 74-75 (noting the existence of the State/EPA Capacity Steering Committee, designed to "lead a federal-state dialog on creating and maintaining an environmental 'partnership' between state and federal officials"). Consistent with this past practice, the EPA issued internal guidelines on compliance with Executive Order 13,132 in November 2008.
154. See Epa's Action Development Process, Guidance on Executive Order 13132: Federalism, supra note 131, at 2 ("For some actions, including those which may not have federalism implications. .. EPA policy is broader than the Executive Order, reflecting EPA's commitment to early and meaningful intergovernmental consultation.").
155. Cal. Dep't of Pub. Health, Drug Safety Program, http://www.cdph.ca.gov/certlic/manfprocdistrib/Pages/Drug.aspx (last visited Mar. 19, 2009).
156. See generally New York State Dep't of Health, http://www.health.state.ny.us/ (last visited Apr. 22, 2009). Most of New York's health-related agencies seem more targeted toward providing services to patients, such as the state's drug pricing program, which provides consumers with information and pricing on the leading prescriptions for given ailments. See New York State Dep't of Health, Prescription Drug Price Website, http://rx.nyhealth.gov/pdpw/(last visited Apr. 22, 2009).
157. As the Department of Agriculture and Markets' largest division, New York's Division of Food Safety and Inspection monitors, among other things, food labeling and advertising, and hosts information seminars for the food industry on safety and labeling. N.Y. State Dep't of Agric. & Mkts., Div. of Food Safety & Inspection, http://www.agmkt.state.ny.us/FS/FSHome.html (last visited Mar. 19, 2009). It samples products for safety and provides services similar to those of the FDA's Center for Food Safety and Applied Nutrition. See Food & Drug Admin., Center for Food Safety and Applied Nutrition: Overview, http://www.cfsan.fda.gov/~lrd/cfsan4.html (last visited Apr. 22, 2009).
158. For links to all state health departments, see State & Local Gov't on the Net, State Health Dep'ts and Servs., http://www.statelocalgov.net/50states-health.cfm (last visited Mar. 19, 2009). All states appear to have some agency body geared toward prescription drug tracking and monitoring. The health commissioner or director typically oversees the state's public health program, which may include a drug program and food inspection program. The title "drug program director" is a position usually held at the county level within certain states. Most state agencies, however, are primarily directed at enforcement; it is unclear whether they would have the incentive or resources to respond to requests from the FDA for comment on issues pertaining to preemption.
159. See Cornell W. Clayton, Law, Politics and the New Federalism: State Attorneys General as National Policymakers, 56 Rev. Pol. 525, 540 (1994) ("These committees encourage standardization of state enforcement standards under federal laws and draft model state statutes. Environmental protection, public land management, antitrust law, consumer protection, charitable trusts and solicitations. securities regulation, regulation of the insurance industry, and utility rate-making are some of the areas addressed by NAAG standing committees since 1980."). NAAG, moreover, also lobbies to affect national legislation. Judith Resnik provides one example whereby NAAG mobilized to influence the 2005 Class Action Fairness Act.
160. See Judith Resnik, Lessons in Federalism from the 1960s Class Action Rule and the 2005 Class Action Fairness Act: "The Political Safeguards" of Aggregate Translocal Actions, 156 U. Pa. L. Rev. 1929, 1961-63 (2008) (describing how NAAG's proposal to protect state actors and expand opportunities for state attorney general participation was implemented).
161. Resnik et al. have similarly argued in favor of giving such governmental entities, which they refer to as "TOGAS," or translocal organizations of government actors, regulatory power through consultation with agencies and inclusion in the policymaking process.
162. See Judith Resnik, Joshua Civin & Joseph Frueh, Ratifying Kyoto at the Local Level: Sovereigntism, Federalism, and Translocal Organizations of Government Actors (TOGAS), 50 Ariz. L. Rev. 709, 776-80 (2008). Resnik et al. come down decidedly against preemption, to spur local experimentation. Id. But so long as these powerful governmental bodies play an active role in regulatory policymaking, I see no reason why preemption need be taken off the table in all circumstances.
163. Collective actions taken by these state intergovernmental organizations have been described as "bottom up" federalism, through which local initiatives-once they reach a critical threshold-promote parallel action by state actors. See, e.g., Charles R. Shipan & Craig Volden, Bottom-Up Federalism: The Diffusion of Antismoking Policies from U.S. Cities to States, 50 Am. J. Pol. SCI. 825, 828, 840 (2006) (attributing the emergence of anti-smoking initiatives at the state and federal levels, in part, to strong anti-smoking advocacy at the local level)
164. Judith Resnik, The Internationalism of American Federalism: Missouri and Holland, 73 Mo. L. Rev. 1105, 1122 (2008) (discussing the more than eight hundred mayors who signed onto a U.S. Conference of Mayors' agreement that sets target dates for compliance with Kyoto Protocol air quality standards).
165. See Samuel Issacharoff & Catherine M. Sharkey, Backdoor Federalization, 53 Ucla L. Rev. 1353, 1370 (2006) ("Congress frequently regulates activities because state regulation, or lack of regulation, of those activities imposes external costs on neighboring states."). Critics counter that such an aggregate approach sacrifices local and state experimentation-a core principle of federalism. Moreover, some contend that such state intergovernmental organizations are prone to suppression of minority views as well as susceptible to capture by outside interests. Cf. Clayton, supra note 138, at 543-44
166. Michael S. Greve, Cartel Federalism?: Antitrust Enforcement by State Attorneys General, 72 U. Chi. L. Rev. 99, 100-01 (2005) (suggesting that the "extraordinary extent of state consensus" on antitrust actions has led to "a partial surrender of state regulatory autonomy" and a concomitant refusal to challenge sister states' anticompetitive conduct). 142. See, e.g., Clayton, supra note 138, at 548-52.
167. See generally States' Wyeth Amicus Brief, supra note 66, at *1 ("The forty-seven amici states, as separate sovereigns in our federal system. ... have a fundamental interest in preserving the appropriate balance of authority between the states and the federal government.. .. In our view, courts should only rarely infer that Congress, although silent on the issue, nonetheless intended to displace state law where it is possible to comply with both state and federal law.").
168. see also Dan Schweitzer, Supreme Court Counsel, Nat'l Ass'n of Att'ys Gen., Panelist Remarks at the New York University Annual Survey of American Law: Tort Law in the Shadow of Agency Preemption (Feb. 27, 2009) (noting that, over time, states have gotten increasingly interested in the preemption of state common law claims because of their experience with preemption in other realms, such as banking, where state agencies are explicitly at risk).
169. 5 U.S.C. § 553 (2006).
170. Jody Freeman, Collaborative Governance in the Administrative State, 45 Ucla L. Rev. 1, 11 n.27 (1997).
171. Richard J. Pierce, Jr., Rulemaking and the Administrative Procedure Act, 32 Tulsa L.J. 185, 192-93 (1996).
172. Exec. Order No. 13,132, 64 Fed. Reg. 43,255, 43,255 (Aug. 4, 1999).
173. Id. at 43,258.
174. The EPA stands as a counterexample. It has been at the forefront in terms of providing internal guidance on how to conduct a suitable FIS consistent with the principles embodied in Executive Order 13,132. See EPA'S Action Development Process, Guidance on Executive Order 13132: Federalism, supra note 131, at 9.
175. Food Labeling: Nutrition Labeling of Dietary Supplements on a "Per Day" Basis, 71 Fed. Reg. 74,785, 74,790 (Dec. 13, 2006) (codified at 21 C.F.R. pt. 101); Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim "Lean," 72 Fed. Reg. 1455, 1459 (Jan. 12, 2007) (to be codified at 21 C.F.R. pt. 101).
176. See supra notes 49-52 and accompanying text. For example, recall the FDA rule on nonoxynol/vaginal contraceptives, in which, contrary to the proposed rule's tentative disclaimer, the final rule asserted preemptive effect. In that case, the FDA solicited comments from the states on May 12, 2006, via fax and email to "elected officials of State governments and their representatives of national organization[s]." Over-the-Counter Vaginal Contraceptive and Spermicide Drug Products Containing Nonoxynol 9; Required Labeling, 72 Fed. Reg. 71,769, 71,783 (Dec. 19, 2007) (to be codified at 21 C.F.R. pt. 201)
177. see also Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment, 73 Fed. Reg. 6014, 6017 (Feb. 1, 2008) (to be codified at 21 C.F.R. pt. 347) (noting that no state commented during the public notice-and-comment period and that FDA reached out to states on December 10, 2007, but received no response).
178. Exec. Order No. 13,132, 64 Fed. Reg. at 43,257.
179. See, e.g., Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Overthe-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling, 71 Fed. Reg. 77,314, 77,345 (proposed Dec. 12, 2006) (to be codified at 21 C.F.R. pts. 201, 343) (asserting the preemptive effect of the proposed rule and noting that "FDA is providing an opportunity for State and local officials to comment on this rulemaking, and will conduct outreach to State and local government or organizations representing them")
180. see also Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim "Lean," 72 Fed. Reg. at 1459 (noting that states had been contacted in addition to the general notice provided to all stakeholders via publication in the Federal Register); Food Labeling: Health Claims; Soluble Dietary Fiber from Certain Foods and Heart Disease, 71 Fed. Reg. 29,248, 29,250 (May 22, 2006) (to be codified at 21 C.F.R. pt. 101) (noting that the agency contacted the states via fax and email about the intended amendment and gave nearly a two-month window to respond). In these latter two examples, however, the FDA had denied that there were federalism impacts under the proposed rules.
181. Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim "Lean," 72 Fed. Reg. at 1459; Food Labeling: Health Claims; Soluble Dietary Fiber from Certain Foods and Heart Disease, 71 Fed. Reg. at 29,250.
182. E.g., Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim "Lean," 72 Fed. Reg. at 1456; Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease, 73 Fed. Reg. 9938, 9946 (interim final rule Feb. 25, 2008) (codified at 21 C.F.R. pt. 101).
183. The barley rule is one of three instances mentioned by Mendelson in which agencies solicited comments from states. See Mendelson, supra note 46, at 719 n.127 (citing Food Labeling: Health Claims; Soluble Dietary Fiber from Certain Foods and Coronary Heart Disease, 71 Fed. Reg. 29,248, 29,250 (May 22, 2006) (codified at 21 C.F.R. pt. 101)); id. at 719 n.126 (citing Transportation Worker Identification Credential (TWIC) Implementation in the Maritime Sector; Hazardous Materials Endorsement for a Commercial Drivers' License, 71 Fed. Reg. 29,396 (proposed May 22, 2006)); id. at 719 n.127 (citing Taking of Marine Mammals Incidental to Commercial Fishing Operations; Atlantic Large Whale Take Reduction Plan (ALWTRP), 71 Fed. Reg. 26,702, 26,704 (temporary rule May 8, 2006)).
184. Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease, 72 Fed. Reg. 5367, 5373 (proposed Feb. 6, 2007) (to be codified at 21 C.F.R. pt. 101).
185. Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease, 73 Fed. Reg. at 9946 (Feb. 25, 2008).
186. The Secretary thanked the FDA for the opportunity to participate in the process and responded that "Kentucky conducts all labeling reviews in accordance with the [FDCA]; therefore, this ruling will not adversely affect our state's actions or conflict with any state laws." Letter from Janie Miller, Sec'y, Cabinet for Health and Family Servs., Ky., to Div. of Dockets Mgmt., FDA 1 (Mar. 14, 2008), available at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-N-0032.
187. Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis, 72 Fed. Reg. 497, 516 (proposed Jan. 5, 2007) (to be codified at 21 C.F.R. pt. 101).
188. Letter from Carl Tubbesing, Deputy Exec. Dir., Nat'l Conference of State Legislatures, to William Schoonover, Docket Operations, U.S. Dep't of Transp. (May 16, 2008) (on file with Duke Law Journal).
189. A subsection of NAAG, the National Association of Medicaid Fraud Control Unit, sent out an alert that the proposed regulation had been published in the Federal Register. The state attorneys general were concerned that the regulation would undermine their ability to enforce the Medicaid program requirements; many state attorneys general have ongoing investigations concerning the rebate program and the three-year time window seemed unduly short. See Letter from Peter Heed, Att'y Gen. of N.H. et al. to Tommy G. Thompson, Sec'y, Dep't of Health & Human Servs., et al. (Oct. 28, 2003) [hereinafter Heed Letter] (on file with Duke Law Journal) (raising concerns that a three-year recordkeeping requirement would be too short for the purposes of state law enforcement); see also Medicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program, 69 Fed. Reg. 508, 511 (interim final rule Jan. 6, 2004) (to be codified at 42 C.F.R. pt. 447) (recognizing concerns raised in NAAG letter and agreeing to change policy from a three-year requirement to a ten-year requirement). My research assistant, Benjamin Heidlage, deserves credit for bringing this example to my attention.
190. Heed Letter, supra note 166.
191. Medicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program, 69 Fed. Reg. at 508 ("In this interim final rule with comment period we are removing the 3-year recordkeeping requirements, replacing them with 10-year recordkeeping requirements on a temporary basis, and soliciting comments on the 10-year requirements.").
192. Federal Motor Vehicle Safety Standards; Roof Crush Resistance, 70 Fed. Reg. 49,223, 49,245 (proposed Aug. 23, 2005) (codified at 49 C.F.R. pt. 571).
193. See Ted R. Miller & Eduard Zaloshnja, Pacific Institute for Research and Evaluation, State, Local, and Tribal Governments' Benefits and Costs from Nhtsa's Proposed Rulemaking on Roof Crush Resistance 2 (2006) ("[T]he preemption of all conflicting State common law requirements, including rules of tort law, would prevent some permanently disabled victims in rollover crashes from recovering losses. As a result, the more seriously disabled could end up on Medicaid, which is partially funded by States.").
194. Susan Frederick, Dir. of the Law & Justice Comm., Nat'l Conference of State Legislatures, Panelist Remarks at the New York University Annual Survey of American Law: Tort Law in the Shadow of Agency Preemption (Feb. 27, 2009).
195. During the Bush II administration, the pattern of nonconsultation coupled with the informal nature of the agency decisions, see supra note 30, made it extraordinarily difficult even for state groups that were in contact with an agency to keep abreast of pre-emption determinations
196. This is part and parcel of the Executive Order's direction that "no agency shall promulgate any regulation that has federalism implications and that preempts State law, unless the agency, prior to the formal promulgation of the regulation. .. consulted with State and local officials early in the process of developing the proposed regulation." Exec. Order No. 13,132, 64 Fed. Reg. 43,255, 43,258 (Aug. 4, 1999). The EPA Guidelines elaborate: "Your consultation should be 'meaningful and timely.' Generally, we interpret 'meaningful and timely' to mean that consultation should begin as early as possible and continue as you develop the proposed rule." Epa's Action Development Process, Guidance on Executive Order 13132: Federalism, supra note 131, at 9. EPA's Office of Congressional and Intergovernmental Relations (OCIR) offers logistical support: "OCIR staff can help you assess issues of concern to other government entities, identify interested government officials, suggest ways for achieving their education and involvement, tailor information about rules for [state and local] government audiences, and develop and implement consultation plans." Id. at 19.
197. Again, the EPA is exemplary. On several occasions, it has engaged in such consultation with the states. See, e.g., Water Quality Standards for Puerto Rico, 72 Fed. Reg. 70,517, 70,523 (Dec. 12, 2007) (to be codified at 40 C.F.R. pt. 131) ("Although. .. Executive Order 13132 does not apply to this final rule, EPA did consult with the Commonwealth of Puerto Rico in developing this rule. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicited comment on the proposed rule from State and local officials."); Component Durability Procedures for New Light-Duty Vehicles, Light-Duty Trucks and Heavy-Duty Vehicles, 71 Fed. Reg. 2843, 2852 (proposed Jan. 17, 2006) (to be codified at 40 C.F.R. pt. 86) ("In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials.")
198. see also Epa's Action Development Process, Guidance on Executive Order 13132: Federalism, supra note 131, at 11 ("In the spirit of EO 13132, it is EPA's policy to promote communications between EPA and [state and local] governments and solicit input from [state and local] government representatives when developing a regulation that will have any adverse impact above a minimal level on [state and local] governments. This internal policy is broader than EO 13132.").
199. Notice-and-comment rulemaking has been subject to a more generalized critique along these lines. See, e.g., Freeman, supra note 145, at 12 ("[T]he notice and comment process often fails to make the best use of available data and information. This is in part a product of timing: only after the Notice of Proposed Rule Making (NPRM) do parties supply detailed arguments about the technical and practical difficulties of implementing a rule, instead of much earlier when the information might be more valuable to the agency in formulating the proposed rule."). 178. Exec. Order No. 13,132, 64 Fed. Reg. at 43,256.
200. One idea, suggested to me by Phil Weiser, would be for each federal agency to have some type of ombudsperson committed to state outreach. Executive Order 13,132 in fact requires agencies to designate a "federalism official," who is charged with certifying compliance with the order. See infra note 206 and accompanying text; see also Epa's Action Development Process, Guidance on Executive Order 13132: Federalism, supra note 131, at 19 n.7 (highlighting the role of the "Regulatory Steering Committee Representative" of EPA's Office of Congressional and Intergovernmental Relations in assisting with outreach to EPA's intergovernmental partners). Another idea, suggested by my student Christopher Terranova, is for each agency to create a working group of interested parties with which it can consult. See Christopher Terranova, Challenging Agency Preemption 19-20 (May 12, 2009) (unpublished manuscript, on file with Duke Law Journal). The Federal Railroad Administration regularly consulted with such a working group before issuing its preemptive rules. See id. (manuscript at 9-10).
201. Federal Motor Vehicle Safety Standards; Seating Systems, Occupant Crash Protection, Seat Belt Assembly Anchorages, School Bus Passenger Seating and Crash Protection, 72 Fed. Reg. 65,509, 65,511 (proposed Nov. 21, 2007) (to be codified at 49 C.F.R. pt. 571).
202. Several of the reforms posited here, moreover, fit within a broader regulatory reform agenda. Cf. Philip J. Weiser, Institutional Design, FCC Reform, and the Hidden Side of the Administrative State 38 (Univ. of Colo. Law Sch. Legal Studies Research Paper Series, Working Paper No. 09-01, 2009), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1336820(outlining a reform agenda for the FCC to "seek to obtain better information, elicit more effective public input, and, finally, enable the public to play a more constructive role in the agency's work").
203. Exec. Order No. 13,132, § 11, 64 Fed. Reg. at 43,259 (stating that the Executive Order "is intended only to improve the internal management of the executive branch, and is not intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, its officers, or any person").
204. See, e.g., Nicholas Bagley & Richard L. Revesz, Centralized Oversight of the Regulatory State, 106 Colum. L. Rev. 1260, 1276 (2006) ("[C]ourts generally cannot spur agency action."). Agency inaction is notoriously difficult to police. Heckler v. Chaney, 470 U.S. 821 (1985), established that an agency's refusal to initiate enforcement proceedings is not ordinarily subject to judicial review. Id. at 831. Agencies, moreover, enjoy a wide berth of discretion "to choose how best to marshal [their] limited resources and personnel to carry out [their] delegated responsibilities." Massachusetts v. EPA, 549 U.S. 497, 527 (2007) (citing Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-45 (1984)).
205. Wyeth v. Levine, 129 S. Ct. 1187 (2009).
206. Id. at 1201. For a description of the 2006 preamble, see supra Part I.A.1.
207. Wyeth, 129 S. Ct. at 1201.
208. There is surprisingly little academic commentary addressing the merits of congressional codification of Executive Order 13,132 (or its precursors). For at least a mention, see Nina A. Mendelson, The California Greenhouse Gas Waiver Decision and Agency Interpretation: A Response to Professors Galle and Seidenfeld, 57 Duke L.J. 2157, 2172 (2008). Professor Mendelson noted the unenforceability of Executive Order 13,132 and stated that "[c]ongressional action is clearly required here." Id. For a more pessimistic assessment, see Patricia L. Donze, Legislating Comity: Can Congress Enforce Federalism Constraints Through Restrictions on Preemption Doctrine?, 4 N.Y.U. J. LEGIS. & PUB. POL'Y 239, 275 (2000-01). As Ms. Donze notes, "Almost every single phrase of the proposed bills would conceivably spur litigation, and there is no assurance that the bills would do anything more than require boilerplate federalism assessments by agencies. .. already under stress due to scarce time and resources." Id.
209. Moreover, they have included more than simply a codification of Executive Order 13,132. For example, the proposed bill from the 106th Congress included a "rule of construction relating to preemption" for use by federal, state, and local court judges that tipped the balance decidedly against preemption-in essence codifying the presumption against preemption. S. 1214, 106th Cong. §§ 4, 6 (1999). But see Federalism Preservation Act of 1999, H.R. 2960, 106th Cong. §2(a) (codifying the terms of Executive Order 12,612).
210. S. 1214, 106th Cong. § 7 (1999). These provisions codified President Ronald Reagan's Executive Order 12,612, Executive Order 13,132's predecessor. Executive Order 12,612 (similar to E.O. 13,132) listed federalism principles for agencies to follow and required a designated federalism official to complete a "federalism assessment." President Clinton's proposed 1998 Executive Order 13,083 (to replace the Reagan order), "which was viewed as a significant retreat from previous executive orders regarding federal preemption," gave additional momentum to backers of the bills. John Dinan, Strengthening the Political Safeguards of Federalism: The Fate of Recent Federalism Legislation in the U.S. Congress, 34 Publius 55, 64 (2004). President Clinton suspended his order after a "firestorm of criticism"-including charges that, ironically, he failed to consult with state groups. Id. But "state and local officials were by this point convinced" that they could no longer rely on executive orders and needed statutory protection. Id.; see also David S. Broder, Executive Order Urged Consulting, but Didn't; State, Local Officials Want Federalism Say, Wash. Post, July 16, 1998, at A15. One day after the FAA cleared a Senate committee, President Clinton issued Executive Order 13,132, perhaps to quell the momentum from the bill's supporters.
211. See Donze, supra note 191, at 269-70 n.176; see also Nat'l Conference of State Legislatures, Summary of Executive Order 13132 on Federalism Issued by Clinton Administration, http://www.ncsl.org/statefed/federalism/exec13132.htm (last visited May 13, 2009) (describing "extensive negotiations between the White House and seven national organizations. .. representing state and local government officials").
212. S. 1214, 106th Cong. § 5.
213. S. REP. NO. 106-159, at 13 (1999). Among the original ten sponsors of the bill, five were Democrats (Bayh (Ind.), Robb (Va.), Breaux (La.), Levin (Mich.), and Lincoln (Ark.)). S. 1214, 106th Cong. The two dissenters in the Committee, however, were both Democrats-Senators Durbin (Ill.) and Cleland (Ga.). S. REP. NO. 106-159, at 13. The House bills, meanwhile, had a much stronger Republican tilt in terms of sponsorship. The Federalism Act, which closely tracked the 1999 FAA (S. 1214)-both included a rule of statutory construction against preemption, a requirement that agencies promulgate a federalism impact statement accompanying proposed rules, and requirements for Congress to state explicitly the preemptive consequences of bills in committee reports-ended up with thirty Republican sponsors and five Democratic sponsors (Condit (Cal.), Moran (Va.), McCarthy (Mo.), Danner (Mo.), and Shows (Miss.)). H.R. 2245, 106th Cong. (1999). The Federalism Preservation Act of 1999, which simply required all federal departments and agencies to comply with Executive Order 12,612, had twenty-four cosponsors-all Republicans. The chief sponsor of that bill was Bob Barr (Ga.). H.R. 2960, 106th Cong. (1999).
214. Neither of the House bill counterparts, H.R. 2245 and H.R. 2960, made it out of Committee.
215. Stephen Labaton, Anti-Federalism Measures Have Bipartisan Support, N.Y. TIMES, Sept. 6, 1999, at A12.
216. Id.; see also Dinan, supra note 193, at 66 ("[H]ealth, labor, and environmental groups. .. strongly opposed [the federalism bills] on the ground that they would prevent the enactment of numerous beneficial statutes and regulations.").
217. S. REP. NO. 106-159, at 27.
218. Sen. Hearing on Regulatory Preemption, supra note 21, at 7-8.
219. Telephone Interview with Susan Frederick, supra note 133. Ms. Frederick kindly provided a copy of the proposed draft bill, which was never introduced into Congress. Draft Bill (on file with the Duke Law Journal). The notice-and-comment provision is in section 7.
220. Draft Bill § 6(f)(4) ("Court Action")
221. See supra notes 95-105 and accompanying text.
222. See supra notes 131-33 and accompanying text.
223. In 2009, the Director of the OMB set out to "develop[] a set of recommendations to the President for a new Executive Order on Federal Regulatory Review" and, as part of the process, invited "public comments on how to improve the process and principles governing regulation." 74 Fed. Reg. 8819 (Feb. 26, 2009). The preexisting guidelines on implementation of Executive Order 13,132 are procedural in nature, focusing on "what agencies should do to comply with [the Order] and how they should document that compliance to OMB." Memorandum from Jacob J. Lew, Director, Office of Mgmt. & Budget, to the Heads of Executive Departments and Agencies, and Independent Regulatory Agencies, Guidance for Implementing E.O. 13132, "Federalism" (Oct. 28, 1999), available at http://www.whitehouse.gov/omb/memoranda/m00-02.pdf.
224. Exec. Order No. 13,132, 64 Fed. Reg. 43,255, 43,258-59 (Aug. 4, 1999).
225. Exec. Order No. 12,866, 58 Fed. Reg. 51,735 (Oct. 4, 1993), amended by Exec. Order No. 13,422, 72 Fed. Reg. 2763 (Jan. 18, 2007); see also Exec. Order No. 13,132, 64 Fed. Reg. 43,255, 43,258 (Aug. 4, 1999) (providing for certification of compliance to OMB when "transmitting any draft final regulation that has federalism implications to [OMB] pursuant to Executive Order 12866"). Executive Order 12,866 defines a "significant regulatory action" in terms of an "annual effect on the economy of $100 million or more." Exec. Order No. 12,866, § 3(f), 58 Fed. Reg. 51,735; id. at § 6(a)(3)(A), 58 Fed. Reg. 51,735 ("[Regulations] not designated as significant will not be subject to [OMB] review."). According to an empirical study by Steven Croley, only 5 percent of federal rules met this standard for OMB review during the period 1981-2000. Steven Croley, White House Review of Agency Rulemaking: An Empirical Investigation, 70 U. CHI. L. REV. 821, 846 (2003). The EPA's federalism guidelines propose a lower dollar figure ($25 million) for establishing reviewability under Executive Order 13,132. See Epa's Action Development Process, Guidance on Executive Order 13132: Federalism, supra note 131, at 6.
226. See supra note 147.
227. See, e.g., Richard L. Revesz & Michael A. Livermore, Inst. For Policy Integrity, N.Y.U. School of Law, Fixing Regulatory Review: Recommendations for the Next Administration 4-5 (2008) [hereinafter Revesz & Livermore, Recommendations].
228. see also Richard L. Revesz & Michael A. Livermore, Retaking Rationality: How Cost-Benefit Analysis CAN Better Protect the Environment and Our Health 31-32 (2008) (stating that the message of Executive Order 12,866 was that "centralized review and cost-benefit analysis could serve as a neutral tool").
229. Bagley & Revesz, supra note 187, at 1267 ("In recent years, the functional appropriateness of Executive Order 12,866 as a template for executive control of the administrative process has not been seriously challenged.").
230. See Office of Info. & Regulatory Affairs, Circular A-4 on Regulatory Analysis (2003), available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf.
231. Revesz & Livermore, Recommendations, supra note 209, at 7 ("The history of federal regulatory review has shown that OIRA's role easily shifts to reflect changing administrative ideologies: starting as a secretive and blunt instrument under President Reagan, changing to more of a facilitator under President Clinton, and reverting to a regulatory gatekeeper under President George W. Bush."); id. at 9 ("A 2003 study by the U.S. General Accounting Office (now called the Government Accountability Office) found that, over the last eight years, OIRA has acted more as a gatekeeper-aggressively imposing its will at the expense of reasoned analysis and science-whereas during the Clinton Administration it played the role of a facilitator."). Revesz and Livermore's recommendations are "geared towards making durable changes in OIRA's roles so that it can become a stabilizing force in regulatory review, rather than merely a mirror of the latest and mercurial administrative agenda." Id. at 7.
232. Wyeth v. Levine, 129 S. Ct. 1187, 1201 (2009) (Agencies have "a unique understanding of the statutes they administer and an attendant ability to make informed determinations about how state requirements may pose an 'obstacle to the accomplishment and execution of the full purposes and objectives of Congress.'" (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941))); id. ("[W]e have attended to an agency's explanation of how state law affects the regulatory scheme."). To be sure, the Court emphasized that preemption is a judicial decision that is informed by agency input. Id. at 1203 ("After conducting our own pre-emption analysis [in Geier], we considered the agency's explanation of how state law interfered with its regulation, regarding it as further support for our independent conclusion that the plaintiff's tort claim obstructed the federal regime.").
233. Id. at 1200.
234. Id. at 1203 ("By contrast, we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law.").
235. Id. at 1200 ("This Court has recognized that an agency regulation with the force of law can pre-empt conflicting state requirements." (citing Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000)); Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985))). Even in such situations, "the Court has performed its own conflict determination, relying on the substance of state and federal law and not on agency proclamations of pre-emption." Id. at 1200-01.
236. Id. at 1204 (Breyer, J., concurring) ("[I]t is possible that such determinations would have pre-emptive effect.").
237. See infra text accompanying note 232
238. See, e.g., Wyeth, 129 S. Ct. at 1201 (comparing Wyeth with 21 U.S.C. § 360k, which "authoriz[es] the FDA to determine the scope of the [Medical Device Amendment's] pre-emption clause"). In this respect, Brian Galle and Mark Seidenfeld have, in my view, interpreted Wyeth too broadly by suggesting that it holds that Congress must clearly delegate the power to preempt before an agency can exercise that power.
239. See Brian Galle & Mark Seidenfeld, Preemption and Federal Administrative Law, 34 Admin. & Reg. L. News (2009) (abstract).
240. Wyeth, 129 S. Ct. at 1201.
241. Medtronic, Inc. v. Lohr, 518 U.S. 470, 505-06 (1996) (Breyer, J., concurring); id. at 495-96 (majority opinion) ("The FDA regulations interpreting the scope of [the statute's] preemptive effect support the [antipreemption] view, and our interpretation of the pre-emption statute is substantially informed by those regulations." (emphasis added)); see also Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 883 (2000) ("We place some weight upon DOT's interpretation of [the regulation's] objectives and its conclusion, as set forth in the Government's brief, that a tort suit such as this one would stand as an obstacle to the accomplishment and execution of those objectives."). In these cases, the Court studiously avoided specifying the level of deference owed agency interpretations on preemption. Several lower courts gave Chevron, or mandatory, deference to the FDA's preemption preamble. See, e.g., Sharkey, Products Liability Preemption, supra note 6, at 512 n.304 (citing cases).
242. See Sharkey, Products Liability Preemption, supra note 6, at 491-98
243. Wyeth, 129 S. Ct. at 1201 ("The weight we accord the agency's explanation of state law's impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness.") (comparing United States v. Mead Corp., 533 U.S. 218, 234-35 (2001) and Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944)).
244. Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983).
245. Id. at 34.
246. United States v. Nova Scotia Food Prods. Corp., 568 F.2d 240 (2d Cir. 1977).
247. State Farm, 463 U.S. at 42-44.
248. Nova Scotia, 568 F.2d at 252. An agency is not expected to respond to each and every comment. See, e.g., MCI WorldCom, Inc. v. FCC, 209 F.3d 760, 765 (D.C. Cir. 2000) ("An agency is not obliged to respond to every comment, only those that can be thought to challenge a fundamental premise.").
249. See, e.g., Letter from Henry A. Waxman, Chairman of Comm. on Oversight & Gov. Reform, to Stephen L. Johnson, Administrator of EPA 3 (Oct. 21, 2008), available at http://oversight.house.gov/documents/20081021110039.pdf (reporting that during the Bush II Administration, the D.C. Circuit and the U.S. Supreme Court rejected an EPA regulation in 18 of 27 Clean Air Act cases); Chris Bowman, Bush Team Battered by Courts on Environment, SAC. BEE, May 19, 2008, at A1 ("[T]he Bush administration won just one" case out of "78 federal court rulings and settlements in [Endangered Species Act] cases resolved since January 2001").
250. See supra note 220.
251. Consider in this regard the vociferous outcry by the states regarding the REAL ID Act. See supra notes 99-101 and accompanying text; see also supra note 104 and accompanying text.
252. Certain state legislative tort reform measures-such as caps on punitive and noneconomic damages-have made strong inroads. See, e.g., Jonathan Klick & Catherine M. Sharkey, What Drives the Passage of Damage Caps?, in Empirical Studies of Judicial Systems Around the Globe (forthcoming 2009) ("A number of states have passed caps on non-economic and punitive damage awards in civil cases."); Catherine M. Sharkey, Unintended Consequences of Medical Malpractice Damages Caps, 80 N.Y.U. L. REV. 391, 396 (2005) ("A majority of states have imposed some kind of cap or limitation on the amount of damages that plaintiffs can recover in a lawsuit."). By contrast, however, tort reform efforts to establish regulatory compliance as an absolute defense to state tort claims have been an abject failure.
253. See Catherine M. Sharkey, Federalism in Action: FDA Regulatory Preemption in Pharmaceutical Cases in State Versus Federal Courts, 15 J.L. & POL'Y 1013, 1022-23 (2007) ("It is hardly an exaggeration to claim that the push for a strong regulatory compliance defense to tort liability. .. advocated by a host of scholars and policymakers has been an abject failure. Today, Michigan stands alone in having adopted, by statute, blanket immunity based upon federal regulatory compliance." (footnote omitted)).
254. The United States has taken the position that "[n]either the Administrative Procedure Act nor Executive Order 13,132 requires FDA to provide notice of and an opportunity to comment on responses to public comments about a proposed rule, setting forth the agency's view of principles of implied conflict preemption in a preamble that is not part of the codified final rule." Brief for Amicus Curiae the United States of America at 19 n.8, Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006) (Civ. No. 05-CV-05500-MMB), 2006 WL 1724170.
255. [21] U.S.C. § 337 (2006); see also In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781, 788 (3d Cir. 1999) ("It is well settled. .. that the FDCA creates no private right of action).
256. For an insightful discussion of these standing and ripeness challenges, see Terranova, supra note 181 (manuscript at 28-30). My discussion in this paragraph borrows from Terranova's discussion.
257. Kennecott Utah Copper Corp. v. U.S. Dep't of Interior, 88 F.3d 1191, 1223 (D.C. Cir. 1996). A preamble that was "an interpretation of an identified statutory provision, [or] a clarification of an otherwise binding regulation," would likely pass this test. Id.; see also NRDC v. EPA, 559 F.3d 561, 564-65 (D.C. Cir. 2009) ("While preamble statements may in some unique cases constitute binding, final agency action susceptible to judicial review, this is not the norm. Agency statements 'having general applicability and legal effect' are to be published in the Code of Federal Regulations." (quoting Federal Register Act, 44 U.S.C. § 1510(a) (citation omitted))).
258. In Kennecott, for example, the D.C. Circuit dismissed the challenge on ripeness grounds, concluding that "[u]nless and until [the Department of the] Interior or another trustee invokes the preamble in an attempt to affect the outcome of a real dispute, there is little need for and no factual basis to inform our inquiry into its validity." Kennecott, 88 F.3d at 1223.
259. Massachusetts v. EPA, 549 U.S. 497 (2007).
260. Id. at 520.
261. Id. at 518.
262. See, e.g., Metzger, supra note 118, at 2062-63 ("[W]hat the majority intends by its invocation of 'special solicitude' for the states in standing analysis is not obvious; such solicitude might mean a generous stance in determining whether the traditional trio of requirements for standing is met, or exempting the states from the traditional analysis altogether when their sovereignty interests are implicated.").
263. Dru Stevenson links the Court's standing innovation with the evolving role of state attorneys general. See Dru Stevenson, Special Solicitude for State Standing: Massachusetts v. EPA, 112 Penn St. L. Rev. 1, 38 (2007) ("Standing is one additional obstacle that every AG must consider before commencing an action. Relaxing the standing requirements for states means that there will be one less hurdle-a significant hurdle that itself could otherwise consume costly litigation resources-for policy-oriented litigation by the state AG's. Now that the costs are lower and the chances of success are greater, proceeding to litigation will be a rational decision for AG's more frequently." (footnote omitted)).
264. Jody Freeman & Adrian Vermeule, Massachusetts v. EPA: From Politics to Expertise, 2007 Sup. Ct. Rev. 51, 52.
265. See Sharkey, Preemption by Preamble, supra note 11, at 256-57
266. See, e.g., Kellogg v. Wyeth, No. 2:07-cv-82, 2008 WL 5272715, at *10 (D. Vt. Dec. 10, 2008) (finding that procedural defects indicate that the FDA's position was not "promulgated in the exercise of [agency] authority" (quoting Gonzales v. Oregon, 546 U.S. 243, 256 (2006))); In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 275 (E.D.N.Y. 2007) ("The FDA cannot be allowed to usher in such a sweeping change in substantive law through the back door.")
267. Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964, 968 & n.3 (D. Neb. 2006) ("The FDA failed to comply with its requirements [under Executive Order 13,132] to communicate with the states and to allow the states an opportunity to participate in the proceedings prior to a pre-emption decision.")
268. McNellis ex rel. DeAngelis v. Pfizer, Inc., No. Civ. 05-1286 (JBS), 2006 WL 2819046, at *9 (D.N.J. Sept. 29, 2006) ("[T]he 2006 [FDA Drug Labeling] Preamble was a novation, not subjected to prior public notice or comment. .. ."), rev'd sub nom. Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008), cert. granted, vacated, and remanded, 129 S. Ct. 1578 (2009) (mem.). But see Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289, 315 n.27 (E.D. Pa. 2007) (rejecting the court's reasoning in Jackson v. Pfizer, Inc.); In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. M: 05-1699 CRB, 2006 WL 2374742, at *7 (N.D. Cal. Aug. 16, 2006) ("[T]he FDA's failure to comply with Executive Order 13132 regarding consultation with local officials about a possible conflict with state law does not mean that this Court cannot consider the FDA's view of how certain state laws stand as an obstacle to the accomplishment of the objectives of Federal law.").
269. Sharkey, Products Liability Preemption, supra note 6, at 498
270. But see Mendelson, supra note 191, at 2164 n.42 (suggesting that the Nova Scotia "obligation to respond to 'significant comments' that courts have imposed as a gloss on Section 553 of the APA" would not seem to extend outside of the rulemaking context proper).
271. The majority relies upon the trial court's finding that "the agency had paid no more than passing attention to the question whether to warn against IV-push administration of Phenergan." Wyeth v. Levine, 129 S. Ct. 1187, 1193 (2009); see also id. at 1199 ("[T]he trial court found 'no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of' IV-push versus IV-drip administration." (quoting the appendix)). The majority in no way distances itself from similar agency reliance in Geier, indeed, the majority contrasts the situation in Wyeth with that in Geier, where the "contemporaneous record. .. revealed the factors the agency had weighed and the balance it had struck." Id. at 1203. The dissent responds that "[t]he FDA has long known about the risks associated with IV push in general and its use to administer Phenergan in particular." Id. at 1218 (Alito, J., dissenting). The majority, however, accuses the dissent of creative parsing and reconstruction of the record to "suggest greater agency attention to the question" Id. at 1199 n.6 (majority opinion). The majority concedes that the agency record is incomplete, commenting upon the "sparse correspondence between Wyeth and the FDA about Phenergan's labeling," id. at 1192, and the "limited" record regarding any newly acquired information in Wyeth's hands, id. at 1197 ("The record is limited concerning what newly required information Wyeth had or should have had about the risks of IV-push administration of Phenergan. .. ."). Furthermore, Wyeth has the "burden in establishing a pre-emption defense" Id. at 1196.
272. Wyeth makes clear that "[i]mpossibility pre-emption is a demanding defense" and "the mere fact that the FDA approved [the drug's] label does not establish" impossibility preemption. Id. at 1199. It provides far less constructive guidance on what would suffice. At times, the Court seems to suggest nothing short of an explicit rejection by the FDA of a proposed warning would do. See id. at 1198 ("[A]bsent clear evidence that the FDA would not have approved a change to Phenergan's label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements."); id. at 1203 n.14 ("[T]he FDA did not consider and reject a stronger warning against IV-push injection of Phenergan"). But, in other places, the Court proposes a lesser burden of coming forward with relevant information regarding the risks. See id. at 1199 ("Wyeth does not argue that it supplied the FDA with an evaluation or analysis concerning the specific dangers posed by the IV-push method."). Defining a necessary and sufficient agency record to establish impossibility pre-emption will dominate the next wave of litigation. In Colacicco, the Third Circuit Court of Appeals preempted state-law failure to warn claims against the manufacturer of selective serotonin reuptake inhibitors, or SSRI, drugs, finding that "a state-law obligation to include a warning asserting the existence of an association between SSRIs and suicidality directly conflicts with the FDA's oft-repeated conclusion that the evidence did not support such an association." Colacicco v. Apotex Inc., 521 F.3d 253, 271 (3d Cir. 2008). The court accorded the FDA's position Skidmore deference, finding it persuasive on account of the consistency, care, formality, and relative expertise of the agency. Id. at 275. The United States argued before the Third Circuit that it is not the preamble that preempts plaintiffs' claims, but rather the FDA's repeated findings that there was insufficient scientific evidence of an association between adult use of antidepressants and suicidality to permit a warning on the labeling for those drugs. Brief of the United States as Amicus Curiae in Support of Defendants-Appellants at 28-29, Colacicco, 521 F.3d 253 (No. 08-437), 2006 WL 5691532. The U.S. Supreme Court vacated and remanded Colacicco in light of Wyeth. Colacicco v. Apotex, Inc., 129 S. Ct. 1578 (2009) (mem.). The Third Circuit then remanded the consolidated cases back to their respective district courts. The U.S. has since rescinded its amicus brief in support of defendants-appellees, stating that "[t]he [FDA] has not yet conducted the sort of reexamination of various preemption issues following the Supreme Court's decision in Wyeth that would be necessary to inform a position of the United States in this case." Letter from Sharon Swingle, U.S. Dep't of Justice, Civil Div., Appellate Staff, to Marcia M. Waldron, Clerk, U.S. Court of Appeals for the Third Circuit (Apr. 28, 2009). Consistent with my argument here, the FDA's regulatory record with respect to SSRI drugs should be front and center. For a review of the FDA regulatory record with respect to SSRI drugs-including findings from internal scientific reviews and several advisory committees convened to study the matter as well as denials of numerous citizen petitions seeking review
273. see Richard A. Nagareda, FDA Preemption: When Tort Law Meets the Administrative State, 1 J. Tort L. 1, 27-30 (2006).
274. Wyeth, 129 S. Ct. at 1221 (Alito, J., dissenting).
275. Id. at 1201 (majority opinion) ("In prior cases, we have given 'some weight' to an agency's views about the impact of tort law on federal objectives when 'the subject matter is technica[l] and the relevant history and background are complex and extensive.'" (quoting Geier v. Am. Honda Motor Co., 529 U.S. 861, 883 (2000))).
276. Id. ("The weight we accord the agency's explanation of state law's impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness." (comparing United States v. Mead Corp., 533 U.S. 218, 234-35 (2001) and Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944))).
277. Id. at 1203 ("[T]he 'complex and extensive' regulatory history and background relevant to this case undercut the FDA's recent pronouncements of pre-emption, as they reveal the longstanding co-existence of state and federal law and the FDA's traditional recognition of state-law remedies-a recognition in place each time the agency reviewed Wyeth's Phenergan label." (citation omitted)).
278. Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49,603 (Aug. 22, 2008) (to be codified at 21 C.F.R. pts. 314, 601, 814); see also supra Part I.A.2.
279. Waxman Letter, supra note 30, at 4
280. Letter from Consumers Union to Div. of Dockets Mgmt., FDA 6 (Mar. 17, 2008), available at http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064803fb60f.
281. The FDA reports 2711, 550, and 789 CBEs for drugs, biologics, and medical devices, respectively. Letter from Stephen R. Mason, Acting Assistant Comm'r for Legislation, FDA to Hon. Edward M. Kennedy, Chairman, Comm. on Health, Educ., Labor, & Pensions, U.S. Senate 2-3 (Mar. 7, 2008), available at http://www.regulations.gov/fdmspublic/ContentViewer?bjectId=09000064804019ec&disposition=attachment&contentType=pdf.
282. See id. at 4. A 2008 report by Representative Waxman, moreover, suggests that FDA career officials raised this same objection internally. Majority Staff of H. Comm. on Oversight & Gov't Reform, 110th Cong., FDA Career Staff Objected To Agency Preemption Policies 14 (2008) [hereinafter Majority Staff Report on Preemption], available at http://oversight.house.gov/documents/20081029102934.pdf ("The rule is not, as it purports to be, consistent with the agency's role in protecting the public health. We have not experienced problems with sponsors' use of CBE supplements to over warn, and this rule tips the balance against early warnings by using vague and confusing terms such as 'causal association' and 'reasonable time' that will be difficult for staff and sponsors to apply." (quoting Email from Jane Axelrad to Dr. John Jenkins et al. (June 17, 2008))).
283. Letter from Kathy Schroeher, Assoc. General Counsel, Johnson & Johnson, to Div. of Dockets Mgmt., FDA, at 1 (Mar. 13, 2008), available at http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064803fbc40&disposition=attachment&contentType=pdf.
284. Id. at 4.
285. Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49,603, 49,607 (Aug. 22, 2008) (to be codified at 21 C.F.R. pts. 314, 601, 814) ("FDA disagrees with this comment [from Johnson & Johnson]. The comment failed to provide a compelling justification for this proposal.").
286. See Sharkey, Products Liability Preemption, supra note 6, at 491-502; Sharkey, What Riegel Portends, supra note 121, at 446-50
287. Jody Freeman and Adrian Vermeule have called "expertise-forcing" the attempt by courts to ensure that agencies exercise expert judgment free from outside political pressures from the White House or political appointees in agencies. Freeman & Vermeule, supra note 242, at 52 ("[T]he Court majority[] increasing[ly] worries about the politicization of administrative expertise. .. .")
288. see also David J. Barron, From Takeover to Merger: Reforming Administrative Law in an Age of Agency Politicization, 76 Geo. Wash. L. Rev. 1095, 1148 (2008) (arguing that judicial review should be "expertise forcing" to "preclude federal agencies from preempting state and local regulators without first demonstrating to the courts that such preemption decisions are not themselves strongly influenced by political considerations."). 263. See Majority Staff Report on Preemption, supra note 257, at 14-15 (noting that officials in the White House and political appointees in the FDA threatened to block the Physician Labeling Rule unless the preemption changes were included); Am. Ass'n for Justice, Get Out of Jail Free: How the Bush Administration Helps Corporations Escape Accountability 7-15 (2008), available at http://www.justice.org/resources/Preemption_Rpt.pdf (summarizing findings from Freedom of Information Act requests that allegedly show a concerted effort during the Bush II administration, in part organized by the Office of Management and Budget, to preempt state laws through agency action without consultation with the states)
289. see also James T. O'Reilly, Losing Deference in the FDA's Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise, 93 Cornell L. Rev. 939, 969 (2008) ("The FDA's [preemption preamble] was the culmination of the Bush Administration's lobbying effort."); David C. Vladeck, The FDA and Deference Lost: A Self-Inflicted Wound or the Product of a Wounded Agency? A Response to Professor O'Reilly, 93 Cornell L. Rev. 981, 991 (2008) ("[T]he Agency effected its dramatic change in position on preemption for political reasons, as opposed to scientific or public policy concerns.").
290. See O'Reilly, supra note 263. In a different context, Freeman and Vermeule have situated Massachusetts v. EPA as "part of a trend in which the Court has at least temporarily become disenchanted with executive power and the idea of political accountability, and is now concerned to protect administrative expertise from political intrusion." Freeman & Vermeule, supra note 242, at 54.
291. In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 273 (E.D.N.Y. 2007); Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964, 968 & n.3 (D. Neb. 2006); see also McNellis ex rel. DeAngelis v. Pfizer, Inc., No. Civ. 05-1286 (JBS), 2006 WL 2819046, at *9 (D.N.J. Sept. 29, 2006) (finding that the FDA preamble constitutes an "unexplained change in position"), rev'd sub nom. Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008), cert. granted, vacated, and remanded, 129 S. Ct. 1578 (2009) (mem.).
292. Wyeth v. Levine, 129 S. Ct. 1187, 1203 (2009) (emphasis added).
293. Id. at 1204.
294. The majority opinion calls the U.S. amicus brief "undeserving of deference" given that "[t]he Government's explanation of federal drug regulation departs markedly from the FDA's understanding at all times relevant to this case." Id. at 1203 n.13.
295. Id. at 1201 (emphasis added); see also id. at 1202 ("[T]he FDA traditionally regarded state law as a complementary form of drug regulation."). There is evidence of a prior antipreemption position: in 1998, the FDA stated that it was "establishing 'minimal standards' for drug labels [and] did not intend 'to preclude the states from imposing additional labelling requirements.'" Id. at 1202 & n. 10 (quoting 63 Fed. Reg. at 66,384) (citing 44 Fed. Reg. 37,437 (1979); 59 Fed. Reg. 3948 (1994)). The dissent, by contrast, interprets the FDA's change in position as a natural and expected shift away from a "decade-old and now-repudiated" statement. Id. at 1229 (Alito, J., dissenting).
296. Cf. Kagan, supra note 117, at 2248 (demonstrating the continuation of an expanded federal power from the Reagan and Bush years into the Clinton administration, albeit for different political ends).