Negotiated rulemaking: The next step in regulatory innovation at the Food and Drug Administration?

Food and Drug Law Journal

Volumn 65, Issue 2, 2010, Pages

  Kobick, Julia ^a  

^a HARVARD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER PARTICIPATION; HUMANS; NEGOTIATING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 83355175386     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (177)

1. Pub. L. No. 110-85, 121 Stat. 823-978.
2. Food and Drug Administration Amendments Act of 2007 (FDAAA), sec. 801(a)(2), §(j)(2)(A)(1), 121 Stat. 904 (2007).
3. Enhancing Drug Safety and Innovation Act of 2007, H.R. 1561, 110th Cong. (2007).
4. Food and Drug Administration Revitalization Act, S. 1082, 110th Cong. (2007).
5. The regulations that the negotiated rulemaking committee would proposed would have established, "(I) procedures to determine which clinical trials results information data elements shall be included in the registry data bank, taking into account the needs of different populations of users of the registry data bank; (II) a standard format for the submission of clinical trials results to the registry bank; (III) a standard procedure for the submission of clinical trial results information, including the timing of posting of results information, to the registry data bank, taking into account the possible impacts on publication of manuscripts based on the clinical trial; (IV) a standard procedure for the verification of clinical trial results information, including ensuring that free text data elements are non-promotional; and (V) an implementation plan for the prompt inclusion of clinical trials results information in the registry data bank." S. 1082, 110th Cong., sec. 231, §(j)(3)(C)(iv) (2007).
6. S. 1082, 110th Cong., sec. 231, §(j)(3)(C)(iii) (2007).
7. Letter from Secretary Michael O. Leavitt to Senator Edward M. Kennedy (Apr. 17, 2007) (on file with FDA and available by searching the FDA website).
8. FDAAA, sec. 801(a)(2), §(j)(3)(D), 121 Stat. 910-912 (2007).
9. 5 U.S.C. §§ 561-570 (2000); enacted Nov. 29, 1990 by Pub. L. No. 101-648, 104 Stat. 4, 969; amended by the Administrative Dispute Resolution Act of 1996, Pub. L. No. 104-320, §§ 1, 11, 110 Stat. 3870, 3873 (eliminating the sunset provision in the original 1990 act and permanently reauthorizing the Negotiated Rulemaking Act).
10. CORNELIUS M. KERWIN, RULEMAKING: HOW GOVERNMENT AGENCIES WRITE LAW AND MAKE POLICY 197 (3d ed. 2003).
11. See PETER BARTON HUTT, RICHARD A. MERRILL & LEWIS A. GROSSMAN, FOOD AND DRUG LAW: CASES AND MATERIALS 1556 (3rd ed. 2007).
12. Lubbers reports that between 1991 and 2007, the EPA has convened nine negotiated rulemakings, and OSHA has held three regulatory negotiations. The Department of Housing and Urban Development (HUD) has held seven, the Department of Transportation thirteen, the Department of Interior eleven, and the Agriculture Department two. Jeffrey S. Lubbers, Achieving Policymaking Consensus: The (Unfortunate) Waning of Negotiated Rulemaking, 49 S. TEX. L. REV. 987, Appendix (2008).
13. See, e.g., Joint Tribal and Federal Self-Governance Negotiated Rulemaking Committee, 65 Fed. Reg. 75,906 (Dec. 5, 2000) (Indian Health Service);
14. Health Care Programs, Fraud and Abuse; Intent to Form the Negotiated Rulemaking Committee for the Shared Risk Exception, 62 Fed. Reg. 28,410 (May 23, 1997) (OIG);
15. Hospice Services Under Medicare Program; Intent to Form Negotiated Rulemaking Committee, 59 Fed. Reg. 52,129 (Oct. 14, 1994) (HCFA).
16. See Lubbers, supra note 12, at 996-1005 (suggesting potential reasons for the waning of negotiated rulemaking between 2000 and 2007).
17. See, e.g., Thomas O. McGarity, Some Thoughts on "Deossifying" the Rulemaking Process, 41 DUKE L.J. 1385-1386 (1992);
18. Richard J. Pierce, Seven Ways to Deossify Agency Rulemaking, 47 ADMIN. L. REV. 59 (1995).
19. President Obama's first official memorandum expressed a commitment to "a system of transparency, public participation, and collaboration." Memorandum for the Heads of Executive Departments and Agencies, Transparency and Open Government, 74 Fed. Reg. 4,685 (Jan. 21, 2009). It made clear the President's intention to foster a collaborative regulatory environment: Knowledge is widely dispersed in society, and public officials benefit from having access to that dispersed knowledge. Executive departments and agencies should offer Americans increased opportunities to participate in policymaking and to provide their Government with the benefits of their collective expertise and information... Executive departments and agencies should use innovative tools, methods, and systems to cooperate among themselves, across all levels of Government, and with nonprofit organizations, businesses, and individuals in the private sector. Executive departments and agencies should solicit public feedback to assess and improve their level of collaboration and to identify new opportunities for cooperation.
20. Id. A month later, the President published a request for public comments for a new Executive Order on federal regulatory review. Federal Regulatory Review, 74 Fed. Reg. 8,819 (Feb. 26, 2009). In particular, he requested comments on "Encouraging public participation in agency regulatory processes; ... Methods of ensuring that regulatory review does not produce undue delay; ... [and t]he best tools for achieving public goals through regulatory process." Id.
21. See, e.g., Cass R. Sunstein, Trimming, 122 HARV. L. REV. 1049, 1053-54 (2009) (defending as honorable the practice of "trimming": compromising or identifying and preserving the best aspects of competing positions to "ensur[e] that no one is excluded, humiliated, or hurt ... [and] reduce social conflict and public outrage");
22. Cass R. Sunstein, Factions, Self-Interest, and the APA: Four Lessons Since 1946, 72 VA. L. REV. 271, 282-284 (1986) ("[T]he purpose of the regulatory process is to select and implement the values that underlie the governing statute and that, in the absence of statutory guidance, must be found through a process of deliberation.");
23. Cass R. Sunstein, Interest Groups in American Law, 38 STAN. L. REV. 29, 63-68 (1985) (identifying several aspects of the regulatory process designed to encourage deliberation and prevent powerful factions from influencing rules in a way that subverts public values).
24. The ACUS developed criteria for when negotiated rulemaking would be appropriate and effective (Recommendation 82-4, 1 CFR §305.82-4) and later recommended procedures that agencies could utilize (Recommendation 85-5, 1 CFR §305.85-5).
25. Philip J. Harter, Negotiating Regulations: A Cure for Malaise, 71 GEO. L. J. 1 (1982).
26. DAVID M. PRITZKER & DEBORAH S. DALTON, NEGOTIATED RULEMAKING SOURCEBOOK 1 (2d ed. 1995).
27. Notice and comment rulemaking is informal rulemaking, governed by 5 U.S.C. § 553 (2006). The agency must propose a rule, provide notice by publishing it in Federal Register, give people the opportunity to participate in the rulemaking through comments, and then issue the rule with a concise general statement of basis and purpose.
28. See JEFFREY S. LUBBERS, A GUIDE TO FEDERAL AGENCY RULEMAKING 128, 155-159 (1998) [hereinafter LUBBERS, A GUIDE TO FEDERAL AGENCY RULEMAKING]; see also Lubbers, supra note 14, at 991-994 (describing the negotiated rulemaking process).
29. See Harter, supra note 19, at 28.
30. The first agency to use negotiated rulemaking was the Federal Aviation Administration (FAA) in 1983. The FAA convened a committee consisting of themselves, airline representatives, pilot organizations, public interest groups, and other interested parties to negotiate a rule about flight and rest time requirements. PRITZKER & DALTON, supra note 20, at 9. Also in 1983, OSHA engaged in negotiations with industry and other relevant stakeholders over the standard for workplace exposure to benzene. OFFICE OF THE SOLICITOR, NEGOTIATED RULEMAKING HANDBOOK OF THE UNITED STATES DEPARTMENT OF LABOR i (1992). The negotiations did not result in a draft rule, but were useful in narrowing the issue. Id.
31. 5 U.S.C. §§ 551-559 (2006); see also 135 CONG. REC. S10060-01 (Aug. 3, 1989) (statement of Sen. Levin) ("[S]ome agencies have decided, despite what other agencies are doing, that they lack the authority to try negotiated rulemaking. A statute is needed to remove any doubt about these agencies' authority to use the process and to serve as Congress' endorsement of negotiated rulemaking activities.").
32. Pub. L. No. 101-648, 104 Stat. 4,969 (codified at 5 U.S.C. §§ 561-570 (2006)).
33. See Texas Office of Pub. Util. Counsel v. FCC, 265 F.3d 313, 327 (5th Cir. 2001) ("The plain language of the statute undermines the notion that the NRA's procedures are mandatory.").
34. 5 U.S.C. § 563.
35. 5 U.S.C. § 561 ("Nothing in this subchapter should be construed as an attempt to limit innovation and experimentation with the negotiated rulemaking process of with other innovative rulemaking procedures otherwise authorized by law.").
36. 5 U.S.C. §§ 563-568 (2006). For an excellent flow chart depicting the various stages of negotiated rulemaking at the EPA, see PRITZKER & DALTON, supra note 20, at 18-19.
37. 136 CONG. REC. S14580-01 (Oct. 4, 1990) (statement of Sen. Levin).
38. Statement on Signing the Negotiated Rulemaking Act of 1990, 2 PUB. PAPERS 1716 (Nov. 29, 1990).
39. NAT'L PERFORMANCE REVIEW, CREATING A GOVERNMENT THAT WORKS BETTER AND COSTS LESS: IMPROVING REGULATORY SYSTEMS 29, 32 (1993), http://govinfo.library. unt.edu/npr/library/reports/reg03.html (last visited Mar. 29, 2009).
40. Exec. Order No. 12,866: Regulatory Planning and Review, §6(a), 58 Fed. Reg. 51,735 (Sept. 30, 1993).
41. Memorandum for Heads of Departments and Agencies, Regulatory Reinvention Initiative, 1 PUB. PAPERS 304 (1995).
42. See Steven P. Croley, Practical Guidance on the Applicability of the Federal Advisory Committee Act, 10 ADMIN. L.J. AM. U. 111, 112-114 (1996).
43. Pub. L. No. 92-463, 86 Stat. 770 (1972) (codified at 5 U.S.C. App. 2).
44. See LUBBERS, A GUIDE TO FEDERAL AGENCY RULEMAKING, supra note 23, at 126 n.94, 131.
45. Pub. L. No. 104-320 §11, 110 Stat. 2870, 3873 (1996).
46. Id. This requirement was necessary because the ACUS had lost its funding in 1995 congressional budget-cuts, and so ceased to exist. See Toni M. Fine, A Legislative Analysis of the Demise of the Administrative Conference of the United States, 30 ARIZ. ST. L.J. 19, 23 (1998).
47. Administrative Dispute Resolution Act of 1996: Hearing on H.R. 4194 Before the Subcomm. on Commercial and Administrative Law of the H. Comm. on the Judiciary, 104th Cong. (1996) (statement of Joseph A. Dear, Assistant Secretary of Labor for Occupational Safety and Health).
48. Memorandum on Agency Use of Alternate Means of Dispute Resolution and Negotiated Rulemaking, 1 PUB. PAPERS 664 (May 1, 1998).
49. Lubbers, supra note 14, at 996.
50. See Exec. Order No. 13, 422, 72 Fed. Reg. 2,763 (Jan.23, 2007);
51. Exec. Order No. 13,258, 67 Fed. Reg. 9,385 (Feb. 28, 2002).
52. Lubbers, supra note 14, at 997.
53. See, e.g., FLA. STAT. §120.54(2)(d) (2009);
54. IDAHO CODE ANN. § 67-5220(2) (2009) ("The notice of intent to promulgate a rule is intended to facilitate negotiated rulemaking, a process in which all interested parties and the agency seek consensus on the content of a rule.");
55. MONT. CODE ANN. §§ 2-5-101 to -110 (2007); NEB. REV. STAT. §§ 84-921 to -932 (2008);
56. TEX. GOV'T CODE ANN. §§ 2008.001-.003, 2008.051-.058 (2007);
57. WASH. REV. CODE §34.05.310 (2009);
58. see also David S. Broder, Learning the Art of Horse Trading, WASH. POST, at B7, May 27, 1990 (describing the success of a mock negotiated rulemaking convened by North Dakota Governor George Sinner and Wyoming Governor Mike Sullivan to address various energy policy proposals).
59. J.W. Reitman & A.R. Gosline, Transportation Planning Model for the Future: Maine's Road from Referendum to Reform, Consensus (No. 22), at 1, Public Disputes Network, Harvard Program on Negotiation, Apr. 1994; see also PRITZKER & DALTON, supra note 20, at 370.
60. Idaho Water Antidegradation Successfully Mediated, 4 Northwest Renewable Resources Center Newsletter 1 (1988); see also PRITZKER & DALTON, supra note 20, at 372.
61. IDAHO CODE ANN. § 37-2725 (2009).
62. TEX. GOV'T CODE ANN. §531.0161 (2007).
63. See supra, note 15; but see William S. Jordan III, Ossification Revisited: Does Arbitrary and Capricious Review Significantly Interfere with Agency Ability to Achieve Regulatory Goals through Informal Rulemaking? 94 NW. U. L. REV. 393 (2000).
64. See Richard E. Levy & Sidney A. Shapiro, Administrative Procedure and the Decline of the Trial, 51 U. KAN. L. REV. 473, 487 (2003).
65. For instance, FDA used formal, on-the-record rulemaking procedures to determine the percentage of peanuts required before a product could be labeled "peanut butter." The agency wanted 90 percent peanuts, while the industry advocated for 87 percent peanuts. Proceedings on this issue last over 10 years. See STEPHEN G. BREYER, RICHARD B. STEWART, CASS R. SUNSTEIN, & ADRIAN VERMEULE, ADMINISTRATIVE LAW AND REGULATORY POLICY: PROBLEMS, TEXT AND CASES 518 (6th ed. 2006).
66. See Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, 435 U.S. 519 (1978) (holding that the APA precludes reviewing courts from requiring agencies to use additional procedures beyond those specified in the APA or other relevant statutes).
67. Todd Rakoff, The Choice Between Formal and Informal Modes of Administrative Regulation, 52 ADMIN. L. REV. 159, 165 (2000) ("[p]romulgating a major rule [under notice and comment proceedings] often takes years and represents a substantial commitment of an agency's resources").
68. Southeastern Minerals, Inc. v. Harris, 622 F.2d 758, 767 (5th Cir.1980) (describing the FDA's delay in responding to a food additive petition and failure to have made an industry-wide policy through rulemaking a "regrettable, needless waste of time");
69. see also CASS R. SUNSTEIN, FREE MARKETS AND SOCIAL JUSTICE 323 (1997) ("The Food and Drug Administration has delayed the entry of beneficial foods and drugs onto the market, significantly increasing risks to safety and health. The 'drug lag' has been a serious problem for Americans."); Rakoff, supra note 59, at 164-165, 168 (describing how the number of FDA rules produced decreased significantly from the 1970s to 2000, and have been replaced by innovations such as guidance documents).
70. See, e.g. Community Nutrition Institute v. Young, 818 F.2d 943 (D.C. Cir. 1987) (finding that FDA's "action levels" for unavoidable contaminants above which a food is deemed adulterated were unenforceable because they had been developed as general statements of agency policy, but should have been subject to notice and comment rulemaking because they had a present effect and were binding).
71. See, e.g., Lars Noah, Doubts About Direct Final Rulemaking, 51 ADMIN. L. REV. 401 (1999).
72. See Michael Asimow, Interim-Final Rules: Making Haste Slowly, 51 ADMIN. L. REV. 703, 704 (1999).
73. Guidance for FDA and Industry: Direct Final Rule Procedures, 21 C.F.R. § 10.40(e)(1) (2000) (interim-final rules);
74. 62 Fed. Reg. 62,466 (Nov. 21, 1997).
75. See supra, notes 27, 41.
76. See PRITZKER & DALTON, supra note 20, at 3; Harter, supra note 19, at 30.
77. See PRITZKER & DALTON, supra note 20, at 3; Harter, supra note 19, at 31.
78. Lee M. Thomas, The Successful Use of Regulatory Negotiation by EPA, 13 ADMIN. L. NEWS 1, 2 (1987).
79. See KERWIN, supra note 10, at 199; Harter, supra note 19, at 28, 31.
80. See Harter, supra note 19, at 31.
81. Id. at 29.
82. Compare Sangamon Valley Television Corp. v. United States, 269 F.2d 221 (D.C. Cir. 1959) (finding the FCC engaged in inappropriate ex parte communications during notice and comment proceedings),
83. and Home Box Office, Inc. v. FCC, 567 F.2d 9 (D.C. Cir. 1977) (same),
84. with Action for Children's Television v. FCC, 564 F.2d 548 (D.C. Cir. 1977) (finding the FCC's ex parte communications with the broadcast industry during notice and comment proceedings did not render subsequent regulations invalid). While FDA regulations permit unlimited contact between private individuals and agency officials, the content of significant communications must be disclosed. 21 C.F.R. §§ 10.65, 10.70, 10.80 (2006).
85. Jody Freeman & Laura I. Langbein, Regulatory Negotiation and the Legitimacy Benefit, 9 N.Y.U. ENVTL. L.J. 60, 63 (2000).
86. Id. at 67-68.
87. Id. at 68.
88. See also Laura I. Langbein & Cornelius M. Kerwin, Regulatory Negotiation Versus Conventional Rulemaking: Claims, Counterclaims, and Empirical Evidence, 10 J. PUB. ADMIN. RES. & THEORY 599, 599-632 (2000); KERWIN, supra note 10, at 201.
89. Cary Coglianese, Assessing Consensus: The Promise and Performance of Negotiated Rulemaking, 46 DUKE L.J. 1255, 1284-1286, 1309 (1997).
90. Philip J. Harter, Assessing the Assessors: The Actual Performance of Negotiated Rulemaking, 9 N.Y.U. ENVTL. L.J 32 (2000).
91. See, e.g., Cary Coglianese, Assessing the Advocacy of Negotiated Rulemaking: A Response to Philip Harter, 9 N.Y.U. ENVTL. L.J. 386 (2001);
92. Andrew P. Morriss, Bruce Yandle, & Andrew Dorchak, Choosing How to Regulate, 29 HARV. ENVTL. L. REV. 179, 195-202 (2005) (finding good arguments on both sides, but generally siding with Coglianese in his empirical debate with Harter);
93. Mark Seidenfeld, Empowering Stakeholders: Limits on Collaboration as the Basis for Flexible Regulation, 41 WM. & MARY L. REV. 411, 458 (2000) ("The collaborative process is most promising, however, if used as a tool to guide agency discretion, rather than as an alternative mechanism to promulgate regulations backed by the coercive power of the state.");
94. Siobhan Mee, Comment, Negotiated Rulemaking and Combined Sewer Overflows (CSOs): Consensus Saves Ossification?, 25 B.C. ENVTL. AFF. L. REV. 213 (1997) (lauding the success of this particular negotiated rulemaking).
95. William Funk, When Smoke Gets in Your Eyes: Regulatory Negotiation and the Public Interest - EPA's Woodstove Standards, 18 ENVTL. L. 55, 57 (1987) (arguing EPA's negotiated woodstove emissions rule went beyond the bounds of the Clean Air Act).
96. Id. at 66-78.
97. Id. at 97.
98. HUTT, MERRILL & GROSSMAN, supra note 11, at 1547-48.
99. 21 U.S.C. §§ 301 et seq. (2006).
100. Id. § 371.
101. 5 U.S.C. § 553 (2006).
102. See John C. Carey, Is Rulemaking Old Medicine at the FDA?, in FOOD AND DRUG LAW: AN ELECTRONIC BOOK OF STUDENT PAPERS (Peter Barton Hutt, ed., 1997), available at http://leda.law.harvard.edu/leda/data/173/jcarey.pdf (arguing that the rulemaking in the FDA has been heavily burdened by procedural requirements imposed by each governmental branch).
103. 21 C.F.R. §10.30(f) permits citizens to file a petition with FDA to "issue, amend, or revoke" an order or regulation.
104. 21 C.F.R. §101.12(h)(14) (2006).
105. Food Labeling; Serving Sizes, 55 Fed. Reg. 29,517-01 (Jul. 19, 1990) (to be codified at 21 C.F.R. § 101.12).
106. Pub. L. No. 101-535, 104 Stat. 2353 (1990).
107. Food Labeling; Serving Sizes, 56 Fed. Reg. 60,394-01 (Nov. 27, 1991) (to be codified at 21 C.F.R. § 101.12).
108. Id. ("Several food industry comments stated that FDA developed the 1990 proposal with no input from industry.").
109. Food Labeling; Serving Sizes, 58 Fed. Reg. 2,229-01 (Jan. 6, 1993);
110. Food Labeling; Serving Sizes; Technical Amendments, 58 Fed. Reg. 44,039-01 (Aug. 8, 1993).
111. Food Labeling; Serving Sizes; Reference Amount for "Salt, Salt Substitutes, Seasoning Salts (e.g., Garlic Salt)," 60 Fed. Reg. 37,616-01 (Jul. 21, 1995).
112. Akzo Salt, Inc., Citizen Petition 18 (Nov. 19, 1993) (received following a Freedom of Information Act request; on file with the author).
113. Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, Pectin, 62 Fed. Reg. 61,476-01 (Nov. 18, 1997).
114. See Church & Dwight Co., Inc., Citizen Petition 1-2 (June 23, 1994) (received following a Freedom of Information Act request; on file with the author). This particular RACC amendment would likely not have been appropriate for negotiated rulemaking, however, because of the small number of stakeholders. Indeed, FDA received no comments related to the proposed rule change. See Food Labeling; Serving Sizes; Reference Amounts for Baking Soda, Baking Powder, Pectin, 64 Fed. Reg. 12,887-01 (Mar. 16, 1999).
115. Food Labeling: Serving Sizes of Products That Can Reasonably Be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes, 70 Fed. Reg. 17,010-01 (Apr. 4, 2005).
116. Food Labeling; Serving Sizes and Nutrition Labeling (Section 610 Review), 73 Fed. Reg. 71,361-01 (Nov. 24, 2008).
117. The Food and Drug Administration's Development, Issuance, and Use of Guidance Documents, 62 Fed. Reg. 8,961-01 (Feb. 27, 1997).
118. First Amendment Issues, 67 Fed. Reg. 34,942 (May 16, 2002).
119. American Feed Industry Association, Docket No. 02N-0209; Request for Comment on First Amendment Issues - Response, at 2,3 n.2 (Oct. 28, 2002), http://www.fda.gov/ohrms/dockets/dockets/02n0209/02n-0209-c000091-vol19.pdf ("The extent to which FDA may restrict truthful, qualified information about products without violating the Constitution is an issue that may be especially amendable to consideration and resolution through the negotiated rulemaking process.")
120. Id. at 1, 4, 5 ("there is a consensus for changing the way FDA limits the dissemination of truthful, non-misleading information about the healthful qualities of pet foods, animal feeds, feed ingredients, and supplements").
121. GAO Report on FDA Blood Oversight Supported by Blood Centers, BUSINESS WIRE, Mar. 12, 1997, at 1.
122. Richard A. Merrill, Risk-Benefit Decisionmaking by the Food and Drug Administration, 45 GEO. WASH. L. REV. 994 (1977) ("Though [the FDCA] is quite lengthy, many of its most important provisions are couched in general language, which FDA has had the responsibility and opportunity to adapt to contemporary problems.").
123. 5 U.S.C. §§ 564, 568(a) (2006).
124. 5 U.S.C. § 568(c) (2006).
125. 5 U.S.C. § 565(c) (2006).
126. But see Coglianese, supra note 77, at 1284-1286, 1309 (disputing the conventional wisdom that negotiated rulemaking does save time and resources in the long run).
127. See supra, note 7, and accompanying text.
128. See supra, notes 94-97, and accompanying text.
129. See supra, notes 106-109, and accompanying text.
130. See infra notes 126-147 and accompanying text.
131. Pub. L. No. 92-463, 86 Stat. 770 (1972) (codified at 5 U.S.C App. 2.); see also Stephen P. Croley & William F. Funk, The Federal Advisory Committee Act and Good Government, 14 YALE J. REG. 451 (1997).
132. 5 U.S.C. App. 2, §5(b)(2) (2006); Public Citizen v. National Advisory Comm. on Microbiological Criteria for Foods, 886 F.2d 419, 425 (D.C. Cir. 1989) (finding that a public interest group challenge under FACA to a Department of Agriculture advisory committee failed to show that the committee was dominated or "inappropriately influenced" by food industry representatives).
133. 21 C.F.R. §14.1(b)(5) (2006).
134. See Whitt Steineker, Who's Guarding the Henhouse?: Conflicts of Interest and the FDA Advisory Committee Scheme, 20 GEO. J. LEGAL ETHICS 935, 941-942 (2007) ("[w]hile there have been instances where the FDA did not follow the recommendation of an advisory committee, such instances represent the minority of occasions"); see also Harter, supra note 19, at 25.
135. See INSTITUTE OF MEDICINE, FOOD AND DRUG ADMINISTRATION ADVISORY COMMITTEES 46-49 (1992); Richard Stewart, Regulation, Innovation, and Administrative Law: A Conceptual Framework, 69 CAL. L. REV. 1256, 1354-57 (1981) (discussing FDA use of advisory committees).
136. 21 C.F.R. §14.40(f)(5) (2006); see also Advisory Committees: Critical to the FDA's Product Review Process, FDA CONSUMER (Jan. 2006), http://www.fda.gov/fdac/special/testtubetopatient/advisory.html ("The FDA also insists on getting industry and public perspectives, and nearly all committees include industry and consumer representation.").
137. Pub. L. No. 94-295, 90 Stat. 539 (1976).
138. See INSTITUTE OF MEDICINE, supra note 130, at 124.
139. 21 C.F.R. § 330.10(a)(1) (2006).
140. FDA has used two Public Boards of Inquiry, reviewing complex scientific issues related to aspartame and Depo Provera. See Aspartame; Ruling on Objections and Notice of Hearing Before a Public Board of Inquiry, 44 Fed. Reg. 31,716 (Jun. 1, 1979);
141. Depo-Provera; Hearing on Proposal to Refuse Approval of Supplemental New Drug Application, 44 Fed. Reg. 44,274 (Jul. 27, 1979).
142. These evidentiary hearings are authorized under 21 U.S.C. § 701(e) (2006).
143. See Administrative Practices and Procedures, 40 Fed. Reg. 40,682 (Sept. 3, 1975) (codified at 21 C.F.R. § 12.32).
144. Sidney A. Shapiro, Scientific Issues and the Function of Hearing Procedures: Evaluating the FDA's Public Board of Inquiry, 1986 DUKE L.J. 288, 341 (1986).
145. See 21 C.F.R. § 13.30 (2006).
146. Administrative Practices and Procedures, 40 Fed. Reg. 40,682 (Sept. 3, 1975).
147. See Shapiro, supra note 138, at 341.
148. Id. at 342.
149. Consumer Participation; Open Meeting, 44 Fed. Reg. 44,274 (Jul. 27, 1979).
150. See, e.g., Food Labeling: Use of Symbols to Communication Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing; Request for Comments, 72 Fed. Reg. 39,815 (Jul. 20, 2007);
151. Food and Drug Administration's Communication of Drug Safety Information; Public Hearing, 70 Fed. Reg. 57,607 (Oct. 3, 2005) ("The purpose of the public hearing is to obtain public input on CDER's current risk communication tools, identify stakeholders for collaboration and implementation of additional tools, and obtain greater understanding of the strengths and weaknesses of CDER's existing risk communication.").
152. BREYER, STEWART, SUNSTEIN, & VERMEULE, supra note 57, at 565.
153. See id.
154. See supra, note 104 and accompanying text.
155. KERWIN, supra note 10, at 170.
156. See HUTT, MERRILL, & GROSSMAN, supra note 11, at 1550 (describing incorporation of preambles into Federal Register postings as an "approach pioneered by FDA").
157. See Katherine M. Glaser, Comment, A Step Toward Preemption: The Effect of the FDA's 2006 Preamble, 80 TEMP. L. REV. 871, 885-888 (2007);
158. see also Cristina Rodriguez, The FDA Preamble: A Backdoor to Federalization of Prescription Warning Labels?, 41 J. MARSHALL L. REV. 161, 175-178 (2007) (discussing how much deference courts should give to FDA preambles).
159. HUTT, MERRILL, & GROSSMAN, supra note 11, at 1556.
160. See supra notes 16-17, and accompanying text.
161. See Administrative Dispute Resolution Act of 1996: Hearing on H.R. 4194 Before the Subcomm. on Commercial and Administrative Law of the H. Comm. on the Judiciary, 104th Cong. (1996) (statement of Joseph A. Dear, Assistant Secretary of Labor for Occupational Safety and Health).
162. See Freeman & Langbein, supra note 73, at 68-69; Langbein & Kerwin, supra note 76, at 599-632.
163. HUTT, MERRILL, & GROSSMAN, supra note 11, at 1556.
164. See, e.g., Community Nutrition Institute v. Young, 818 F.2d 943 (D.C. Cir. 1987).
165. National Resources Defense Council v. EPA, 859 F.2d 156, 194-195 (D.C. Cir. 1988).
166. 5 U.S.C. § 570 (2006). Additionally, the composition of the negotiated rulemaking committee is not subject to judicial review. Center for Law and Educ. v. U.S. Dept. of Edu., 209 F. Supp. 2d 102 (D.D.C. 2002).
167. This observation was confirmed in an interview with Jeffrey Senger, Deputy Chief Counsel at FDA. Telephone Interview with Jeffrey Senger, Deputy Chief Counsel, FDA, in Washington, DC, (Jan. 30, 2009).
168. See Harter, supra note 19, at 7.
169. Administrative Dispute Resolution Act of 1996: Hearing on H.R. 4194 Before the Subcomm. on Commercial and Administrative Law of the H. Comm. on the Judiciary, 104th Cong. (1996) (statement of Joseph A. Dear, Assistant Secretary of Labor for Occupational Safety and Health).
170. See Blair P. Bremberg, Pre-Rulemaking Regulatory Development Activities and Sources as Variables in the Rulemaking Fairness Calculus: Taking a Soft Look at the Ex-APA Side of Environmental Policy Rulemakings, 6 J. MIN. L. & POL'Y 1, at text accompanying footnotes 149-62 (1990/91) (comparing the FDA's FACA-chartered advisory committees with negotiated rulemaking).
171. Joseph G. Contrera, The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become?, 8 ADMIN. L. J. AM. U. 927, 937-939 (1995).
172. United States v. Nova Scotia Food Products Corp., 568 F.2d 240, 243 (2d Cir.1977).
173. 21 C.F.R. Part 122 (1977).
174. Nova Scotia, 568 F.2d at 245.
175. Id. at 252.
176. Id. at 253.
177. 5 U.S.C. § 561 (2006).