Congress' new infrastructural model of medical privacy

Notre Dame Law Review

Volumn 84, Issue 2, 2009, Pages 585-654

  Evans, Barbara J ^a  

^a UNIVERSITY OF HOUSTON   (United States)

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EID: 62249114172     PISSN: 07453515     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (351)

1. U.S. Dep't of Health & Human Servs., Nationwide Health Information Network (NHIN): Background, http://www.hhs.gov/healthit/healthnetwork/ background/ (last visited Oct. 5, 2008).
2. Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (codified as amended in scattered sections of 21 U.S.C.).
3. sect;905, 121 Stat. at 944-49 (codified at 21 U.S.C.A. §355 (k)(3)-(4) (West Supp. 2008)).
4. U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., FDA's Sentinel Initiative, http://www.fda.gov/oc/initiatives/advance/sentinel/ (last visited Oct. 10, 2008); see also U.S. FOOD & DRUG ADMIN., U.S. DEP'T OF HEALTH & HUMAN SERVS., THE SENTINEL INITIATIVE 1 (2008), http://www.fda.gov/oc/initiatives/advance/ reports/report0508.pdf (discussing the goals and structure of the Sentinel Initiative).
5. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3)(B)(ii).
6. For persons with health coverage, odds of being in the system are even greater than one in one in three, since the system's initial 100 million inputs are expected to be drawn from Medicare and insurance claims data. See discussion infra Part I.
7. See Sharona Hoffman, Continued Concern: Human Subject Protection, The Institutional Review Board, and Continuing Review, 68 TENN. L. REV. 725, 728 (2001) (finding that an average of 4,237 human subjects are needed before a single new drug reaches the marketplace).
8. See U.S. FOOD & DRUG ADMIN., supra note 4, at 5; see also Barbara J. Evans, What Will It Take to Reap the Clinical Benefits of Pharmacogenomics?, 61 FOOD & DRUG L.J. 753, 783-85 (2006) (describing the risks and benefits of off-label uses); Margaret Z.Johns, Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest, 58 HASTINGS L.J. 967, 969 (2007) (discussing the health risks of off-label prescription use); David C. Radley et al., Off-label Prescribing Among Office-Based Physicians, 166 ARCHIVES OF INTERNAL MED. 1021 (2006) (reporting statistics on the prevalence of off-label use); Alastair J.J. Wood et al., Making Medicines Safer-The Need for an Independent Drug Safety Board, 339 NEW ENG. J. MED. 1851, 1851 (1998) (discussing several drugs that exhibited rare or late-emerging risks after FDA approval).
9. See Barbara J. Evans & David A. Flockhart, The Unfinished Business of U.S. Drug Safety Regulation, 61 FOOD & DRUG L.J. 45, 45-48 (2006) (summarizing late-emerging drug safety risks).
10. See id. at 47-54 (discussing problems with FDA's postmarket monitoring and reporting systems that emphasize collection of data which would have been relevant during premarket approval, but which are not necessarily relevant to safe clinical use); see also U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., Sentinel Network Public Meeting 4 (Mar. 7, 2007) [hereinafter FDA, March 7 Proceedings] (statement of Dr. Andrew von Eschenbach), http://www.fda.gov/ohrms/ dockets/dockets/07n0016/07n-0016-tr00001. pdf (discussing how developments in technology now afford FDA the opportunity to collect necessary information during the postmarket period).
11. See U.S. FOOD & DRUG ADMIN., supra note 4, at 11 (explaining that the HHS Secretary directed FDA to expand its current system for monitoring medical product performance by capitalizing on the emerging sciences of information technology and drug safety).
12. See generally U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., FDA's Critical Path Initiative, http://www.fda.gov/oc/ initiatives/criticalpath/ (last visited Oct. 10, 2008) (providing information about the goals and activities of the Critical Path Initiative).
13. COMM. ON THE ASSESSMENT OF THE U.S. DRUG SAFETY SYS., INST. OF MED., THE
14. FUTURE OF DRUG SAFETY 167-73 (Alina Baciu et al. eds., 2006).
15. U.S. GOV'T ACCOUNTABILITY OFFICE, DRUG SAFETY: IMPROVEMENT NEEDED IN FDA's POSTMARKET DECISION-MAKING AND OVERSIGHT PROCESSES 1, 4-6 (2006), available at http://www.gao.gov/new.items/d06402.pdf.
16. U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., The Sentinel Initiative: Fact Sheet, http://www.fda.gov/oc/initiatives/advance/ sentinel/factsheet. html (last visited Nov. 14, 2008).
17. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3)(C)(i)(III)(aa)-(cc) (West Supp. 2008).
18. By "stored" specimens, I refer to previously collected specimens left over from prior surgical and diagnostic procedures to which the patient consented during the course of medical care. Compulsory collection of new specimens would not be lawful under the clause in question.
19. Press Release, U.S. Dep't of Health & Human Servs., New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care (May 22, 2008), available at http://www.hhs.gov/news/press/2008pres/05/ 20080522a.html.
20. Medicare Program; Medicare Part D Claims Data, 73 Fed. Reg. 30,664, 30,664 (May 28, 2008) (to be codified at 42 C.F.R. pt. 423).
21. U.S. FOOD & DRUG ADMIN., supra note 4, at 18.
22. See FDA, March 7 Proceedings, supra note 10, at 73 (statement of Dr. Richard Platt).
23. Id.
24. Id. at 72-73 (statement of Dr. Miles Braun) (querying whether a 100-million-person database might fail to be representative of important subgroups of the American population).
25. Id. at 57 (statement of Dr. Marc Overhage).
26. See id. at 57-59; see also id. at 66-68, 71 (statement of Dr. Richard Piatt) (discussing the need, in occasional instances, to review full medical records to assess causes of specific adverse incidents).
27. See id. at 114-18 (statements of Drs. Michael Caldwell and Jeffrey Shuren).
28. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3)(C)(iii) (West Supp. 2008).
29. Id., 21 U.S.C.A. § 355 (k)(4)(A)(i)-(iii); see also U.S. FOOD & DRUG ADMIN., supra note 4, at 16 (showing a research component as part of the system's organizational structure).
30. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(4)(A), (D).
31. Press Release, U.S. Dep't. of Health & Human Servs., New Law Ensures Access to Medical Treatments and Information (Sept. 27, 2007), available at http://www.hhs. gov/news/press/2007pres/09/pr20070927e.html.
32. See, e.g., Press Release, U.S. Dep't of Health & Human Servs., supra note 18, at 2 (noting that Americans not on Medicare average thirteen prescriptions per year, while those on Medicare average about twenty-eight per year). Those Medicare beneficiaries who consider themselves in poor health consume about forty-five prescriptions per year. Id. (citing U.S. Dep't of Health & Human Servs., Medicare Current Beneficiary Survey (2004), http://www.cms.hhs.gov/MCBS/Downloads/A04%20Ric %201.pdf); see also U.S. Dep't of Health & Human Sevs., Medicare Current Beneficiary Survey (MCBS), http://www.cms.hhs.gov/LimitedDataSets/ll-MCBS.asp (last viewed Nov. 14, 2008) (describing the Medicare Current Beneficiary Survey). Other Americans use about thirteen prescriptions per year, according to a 2007 study by the Agency for Healthcare Research and Quality. See Press Release, Agency for Healthcare Research & Quality, Drug Spending Increases More Than 2.5 Times in 8 Years (May 16, 2007), available at http://www.ahrq.gov/ news/nn/nn051607.htm.
33. JOSE A. GÓMEZ-IBÁÑEZ, REGULATING INFRASTRUCTURE 4 (2003).
34. See Jim Chen, The Nature of the Public Utility: Infrastructure, the Market, and the Law, 98 Nw. U. L. REV. 1617, 1617-18 (2004) (reviewing GÓMEZ- IBÁÑEZ, supra note 32).
35. See Richard A. Posner, Natural Monopoly and Its Regulation, 21 STAN. L. REV. 548, 548 (1969).
36. Chen, supra note 33, at 1620.
37. Joseph D. Kearney & Thomas W. Merrill, The Great Transformation of Regulated Industries Law, 98 COLUM. L. REV. 1323, 1334 (1998).
38. CHARLES F. PHILLIPS, JR., THE REGULATION OF PUBLIC UTIUTIES 171-73 (3d ed. 1993).
39. Posner, supra note 34, at 607.
40. See infra Part III.
41. See infra Part LB.
42. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3) (West Supp. 2008).
43. Id., 21 U.S.C.A. §355(k)(4).
44. FDA, March 7 Proceedings, supra note 10; U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., Proceedings, Sentinel Network Public Meeting (Mar. 8, 2007) [hereinafter FDA, March 8 Proceedings], http://www.fda.gov/ohrms/ dockets/dockets/07n0016/07n-0016-tr00002.pdf.
45. FDA, March 7 Proceedings, supra note 10, at 51-56 (statement of Dr. Marc Overhage); see also FDA, March 8 Proceedings, supra note 43, at 74 (statement of Dr. Clement McDonald) (discussing the importance and difficulty of linking data longitudinally).
46. See FDA, March 7 Proceedings, supra note 10, at 23 (statement of Dr. Jeffrey Hill).
47. See U.S. FOOD & DRUG ADMIN., supra note 4, at 13-16 (explaining that the goal of the Sentinel System is to create a national, integrated, electronic system for monitoring medical product safety that still protects the privacy of the persons whose medical data are used in the system).
48. See FDA, March 7 Proceedings, supra note 10, at 12 (statement of Dr. Janet Woodcock) (explaining that the goal of the Sentinel System is not to create a "grand database," but rather to build on existing database efforts and promote connectivity).
49. See U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., The Sentinel Initiative: Questions and Answers, http://www.fda.gov/oc/ initiatives/advance/ sentinel/qanda.html (last visited Nov. 14, 2008).
50. See Chen, supra note 33, at 1629, 1652, 1707.
51. See, e.g., Massachusetts v. Microsoft Corp., 373 F.3d 1199 (D.C. Cir. 2004) (remedy appeal); United States v. Microsoft Corp., 147 F.3d 935 (D.C. Cir. 1998) (contempt proceeding); New York v. Microsoft Corp., 224 F. Supp. 2d 76 (D.D.C. 2002) (non-settling states' remedy); United States v. Microsoft Corp., 231 F. Supp. 2d 144 (D.D.C. 2002) (Justice Department settlement approval); United States v. Microsoft Corp., 87 F. Supp. 2d 30 (D.D.C. 2000) (conclusions of law), aff'd in part, rev'd in part en banc, 253 F.3d 34 (D.C. Cir. 2001) (merits appeal); United States v. Microsoft Corp., 84 F. Supp. 2d 9 (D.D.C. 1999) (findings of fact).
52. See PHILLIPS, supra note 37, at 172-73; see also GÓMEZ- IBÁÑEZ, supra note 32, at 20-21; Chen, supra note 33, at 1624-28 (reviewing Gómez- Ibáñez's discussion of government regulation of infrastructure operation).
53. Chen, supra note 33, at 1628.
54. See id. at 1629 (citing GÓMEZ- IBÁÑEZ, supra note 32, at 13); Daniela Klingebiel & Jeff Ruster, Why Infrastructure Financing Facilities Often Fall Short of Their Objectives 7 (World Bank Policy Research Working Paper, No. 2358, 2000).
55. GÓMEZ-IBÁÑ EZ, supra note 32, at 2; see also Chen, supra note 33, at 1632 (citing STEPHEN BREYER, REGULATION AND ITS REFORM 181-83 (1982)).
56. GÓMEZ-IBÁÑ EZ, supra note 32, at 2.
57. See Chen, supra note 33, at 1634.
58. See Klingebiel & Ruster, supra note 53, at 7.
59. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3)(C)(iii) (West Supp. 2008).
60. Promoting Disease Management in Medicare: Hearing Before the Subcomm. on Health, H. Comm. on Ways & Means, 107th Cong. 22-23 (2002) (statement of Dr. Gerard Anderson, Director, Robert Wood Nat'l Program P'ship for Solutions: Better Lives for People with Chronic Conditions).
61. See, e.g., M. Susan Marquis & Kanika Kapur, Employment Transitions and Continuity of Health Insurance: Implications for Premium Assistance Programs, HEALTH AFF., Sept.-Oct. 2003, at 198, 198-99 (noting that employment is not static and that job turnover due to layoffs or other circumstances results in insurance turnover); see also FDA, March 8 Proceedings, supra note 43, at 53 (statement of Dr. Clement McDonald) (discussing twenty-percent rate of membership turnover in some HMOs).
62. See FDA, March 8 Proceedings, supra note 43, at 42 (statement of Dr. Robert M. Califf); id. at 23-24 (statement of Dr. Miles Braun).
63. See supra note 44 and accompanying text.
64. Pub. L. No. 104-191, 110 Stat. 1936 (codified as amended in scattered sections of 18, 26, 29, 42 U.S.C.).
65. C.F.R. pts. 160, 164 (2007).
66. Under the HIPAA Privacy Rule, covered entities such as doctors and insurers need an authorization signed by the patient before they can disclose health data containing patient-identifying information to the private operator. Absent an authorization, they can only supply health data to the private operator in coded form (i.e., with a code number substituted for any information that would allow the patient to be identified). 45 C.F.R. § 164.514(b)(2)(i)(R), (c). Moreover, the coded disclosure would be subject to HIPAA's "minimum necessary" standard, which limits the amount of health data that can be released. See id. § 164.514(d). Alternatively, the doctor and insurer could release identified health data to the private operator if their respective HIPAA Privacy Boards or Institutional Review Boards granted a waiver of authorization under the Privacy Rule. See id. § 164.512 (i). However, it seems highly unlikely that release of identified data to a private operator, whose business model rests on commercial sale of data, could qualify under the criteria for granting a waiver, which include, among other things, that risks to patient privacy be minimal. See id. Even if the waiver criteria could be met, the process of obtaining waivers would be unwork-ably cumbersome for a data network of the scale envisioned by FDAAA. Thus, it appears that a private operator only would be able to receive data from HIPAA-cov-ered entities in coded form. This fact makes it impossible for the private operator to link data from disparate sources longitudinally to create LPHD. Let us suppose the private operator receives coded data relating to a particular patient from two different sources-for example, clinical observations from the patient's oncologist and insurance claims data from the patient's insurer. Each data set would have a different code attached to it-one code generated by the doctor and a separate code generated by the insurer. Without additional identifying information, the private operator would be unable to ascertain that both of these coded data sets relate to the same person. Therefore, the private operator cannot perform the required longitudinal linkage between claims data and clinical observations. The HIPAA Privacy Rule presents a legal barrier to private sector development of the needed infrastructure for supplying LPHD for use in postmarket drug surveillance. By passing section 905 of FDAAA, Congress deemed regulatory intervention to be necessary in order to resolve this barrier and let private sector investment in infrastructure be mobilized.
67. See Chen, supra note 33, at 1624-25 (citing GÓMEZ-IBÁÑEZ, supra note 32, at 20).
68. See generally R.H. Coase, The Problem of Social Cost, 3 J.L. & ECON. 1 (1960) (analyzing how high transaction costs can affect societal and economic development); Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticom-mons in Biomedical Research, 280 SCIENCE 698 (1998) (discussing how allocation of private intellectual property rights in genomic discoveries can impede biomedical research); Michael A. Heller, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, 111 HARV. L. REV. 621 (1998) (examining how the allocation of private property rights can raise transaction costs and result in underutilization of resources).
69. GÓMEZ-IBÁÑ EZ, supra note 32, at 22; see also Chen, supra note 33, at 1627 (citing Professor Gómez- Ibáñez's for the proposition that ambiguous property rights are not a major source of transaction costs in infrastructure projects); Letter from Donald F. Santa, Jr., President, Interstate Natural Gas Ass'n of Am., to the Hon. John Cornyn, Senator (Sept. 20, 2005), available at http://www.ingaa.org/cms/15/3560/3634/ 3665.aspx (noting that pipeline operators successfully negotiate land-use agreements with ninety to ninety-five percent of landowners in proposed pipeline pathways but encounter barriers to access to remaining parcels of land).
70. GÓMEZ-IBÁÑ EZ, supra note 32, at 5.
71. See 15 U.S.C. § 717f (2006).
72. See Rina Hakimian & David Korn, Ownership and Use of Tissue Specimens for Research, 292 JAMA 2500, 2502-03 (2004). But see Lori Andrews, Who Owns Your Body ? A Patient's Perspective on Washington University v. Catalona, 34 J. L. MED. & ETHICS 398, 400 (2006) (noting that some courts have held that human tissue outside the body can be considered property of the individual or next of kin); Letter from Simon P. Cohn, Chairman, Nat'l. Comm. on Vital and Health Stat., to the Hon. Michael O. Leavitt, Secretary, U.S. Dep't of Health & Human Servs. (Feb. 21, 2008), available at http://ncvhs.hhs.gov/0802201t.pdf (recognizing the importance of individual control over disclosures of health data, but not calling for an individual property right in such data).
73. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3)(C)(i)(I) (West Supp. 2008).
74. In addition to HIPAA's public health exception, 45 C.F.R. § 164.512(b) (1) (i) (2007), the Privacy Rule also contains a "health- oversight exception" that potentially is relevant to the Sentinal System. Id. § 164.512(d)(l)(iii). This allows release of data, without patient authorization, to an agency for use in verifying that regulated entities are complying with regulations. Many, but not all, of the activities envisioned in section 905 potentially fit within this HIPAA exception. HIPAA's "FDA exception," 45 C.F.R. § 164.512(b) (1) (ii), is something of a red herring for purposes of section 905. It allows disclosure of identified data without patient authorization for use in postmarket surveillance and certain other activities relating to FDA-regulated products. However, it provides for disclosure of data to the "responsible person"-that is, to the manufacturer of a drug that is subject to FDA regulation-rather than to FDA itself. The FDA exception may be relevant, however, in resolving questions about access to Sentinel System data by product manufacturers. The Privacy Rule, 45 C.F.R. § 164.512(i), provides procedures for waiver or alteration of HIPAA's usual authorization requirements; this provides another avenue for obtaining data without a standard HIPAA authorization. Finally, it might be possible to frame some Sentinel System activities-particularly those that gather data to provide feedback and reports for patients and physicians, as being part of "treatment" or "quality improvement," which are outside HIPAA's authorization requirements.
75. See Standards for Privacy of Individually Identifiable Health Information, 65 Fed. Reg. 82462, 82691 (to be codified at 45 C.F.R. pts. 160, 164) (discussing HHS' rationale for balancing benefits of research against privacy risks in the HIPAA Privacy Rule); see also Lawrence O. Gostin & James G. Hodge, Jr., Personal Privacy and Common Goods: A Framework for Balancing Under the National Health Information Privacy Rule, 86 MINN. L. REV. 1439, 1441, 1470-72 (2002) (suggesting rules for balancing public and private interests that apply to the HIPAA Privacy Rule).
76. C.F.R. § 164.512(b)(l)(i).
77. FDAAA § 901, 21 U.S.C.A. §§ 355(o), (p), 355-1 (West Supp. 2008).
78. Id. § 915, 21 U.S.C.A. § 355(r).
79. C.F.R. § 164.514(h) (2) (ii) (C). The verification standards of section 514(h) apply to any disclosure permitted under subpart E of HIPAA, and therefore apply to disclosures made under the public health exception of 45 C.F.R § 164.512(b)(l)(i).
80. Ctrs. for Disease Control & Prevention, U.S. Dep't of Health & Human Servs., HIPAA Privacy Rule and Public Health, MORBIDITY & MORTALITY, WKLY. REP., Apr. 11, 2003, at 1,1, available at http://www.cdc.gov/mmwr/pdf/other/m2e4111.pdf.
81. Interstate Commerce Act, ch. 104, 24 Stat. 379 (1887) (codified as amended in scattered sections of 49 U.S.C. app.).
82. Shipping Act of 1916, ch. 451, 39 Stat. 728, 733-35 (1916) (codified as amended at scattered sections of 46 U.S.C. app.).
83. Packers and Stockyards Act of 1921, ch. 64, 42 Stat. 159 (codified as amended at 7 U.S.C. §§ 181-229b (2006)).
84. Communications Act of 1934, ch. 652, 48 Stat. 1064 (codified as amended at 47 U.S.C.A. §§ 151-614 (West 2001 & Supp. 2008)).
85. Id.
86. Motor Carrier Act of 1935, ch. 498, 49 Stat. 543 (codified as amended in scattered sections of 49 U.S.C).
87. Public Utility Act of 1935, ch. 687, 49 Stat. 838 (codified as amended at scattered sections of 16 U.S.C).
88. Natural Gas Act of 1938, ch. 556, 52 Stat. 821 (codified as amended at 15 U.S.C. §§ 717-717w (2006)).
89. Civil Aeronautics Act of 1938, ch. 601, 52 Stat. 973 (codified as amended and before repeal at scattered sections of 49 U.S.C).
90. See Kearney & Merrill, supra note 36, at 1333-34.
91. Id. at 1325.
92. Warrick Smith, Utility Regulators-The Independence Debate, PUB. POL'Y FOR PRTV. SECTOR, Oct. 1997, at 2, available at http://www.ictregulationtoolkit.org/en/Docu- ment. 1454.pdf (explaining that under a discretionary regulatory scheme a regulatory commission or an individual regulator is granted substantial discretion to set prices and services standards for the regulated firm); see also GÓMEZ- IBÁÑEZ, supra note 32, at 11-13, 27-32 (describing discretionary regulation as one of the available regulatory alternatives); Chen, supra note 33, at 1628 (noting that "most American lawyers" would call discretionary regulation "public utility regulation" (internal quotations omitted)).
93. Chen, supra note 33, at 1628.
94. Peter L. Smith & Björn Wellenius, Mitigating Regulatory Risk in Telecommunications, PUB. POL'Y FOR PRTV. SECTOR, July 1999, at 2, available at http:// rru.worldbank.org/documents/publicpolicyjournal/189smith.pdf (citing REGULATIONS, INSTITUTIONS, AND COMMITMENT (Brian Levy & Pablo T. Spiller eds., 1996)).
95. See Chen, supra note 33, at 1618.
96. See Kearney & Merrill, supra note 36, at 1333-40.
97. Id. at 1325, 1359-64; see also Chen, supra note 33, at 1618 (noting that the regulation of infrastructure can be viewed as a "larger legal challenge of disciplining monopoly").
98. See, e.g., Federal Power Act § 205, 16 U.S.C. § 824d(a) (2006) (declaring unlawful any rate charged by a public utility "in connection with the transmission or sale of electric energy" that is not "just and reasonable").
99. See PHILLIPS, supra note 37, at 60.
100. Id. at 562-63. 100 Id.
101. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3)(C)(i)(I) (West Supp. 2008).
102. Id., 21 U.S.C.A. § 355(k)(3)(C)(i)(II).
103. Id., 21 U.S.C.A. § 355(k)(3)(C)(i)(III).
104. Id., 21 U.S.C.A. § 355(k)(3)(C)(i)(IV)-(VI).
105. Id., 21 U.S.C.A. § 355(k) (4) (A).
106. Id., 21 U.S.C.A. § 355(k)(4)(A)(i), (iii).
107. Id., 21 U.S.C.A. § 355(k)(4)(A)(ii).
108. Id., 21 U.S.C.A. § 355(k)(4)(A).
109. Id. § 901(b), 21 U.S.C.A. § 355-1 (b)(1); id. § 905, 21 U.S.C.A. § 355(k) (3) (C) (i)(II).
110. Federal Food, Drug, and Cosmetic Act (FFDCA) § 505(d), 21 U.S.C. § 355(d) (2006).
111. See Douglas C. Throckmorton, Acting Deputy Dir., Ctr. for Drug Evaluation & Research, U.S. Food & Drug Admin., Presentation on Efficacy Biomarkers: Efficacy/ Risk Assessment (Oct. 6, 2005), http://www.fda.gov/cder/ genomics/presentations- 20051006/051006-07-Throckmorton.pdf; see also CTR. FOR DRUG EVALUATION & RESEARCH, U.S. FOOD & DRUG ADMIN., MANUAL OF POLICIES AND PROCEDURES § 6010.3 (2007) [hereinafter CDER, MANUAL OF POLICIES AND PROCEDURES], available at http://www.fda.gOv/cder/mapp/6010.3.pdf (discussing risk factors to include, and not to include, when assessing the risk-benefit ratio for a drug); INT'L CONFERENCE ON HARMONISATION OF TECH. REQUIREMENTS FOR REGISTRATION OF PHARM. FOR HUMAN USE, GUIDANCE FOR INDUSTRY: E2E PHARMACOVIGILANCE PLANNING 2 (2005), available at http://www.fda.gov/CBER/gdlns/ichpvp.pdf (explaining that FDA's "decision to approve a drug is based on its having a satisfactory balance of benefits and risks within the conditions specified in the product labeling"); INT'L CONFERENCE ON HARMONISATION OF TECH. REQUIREMENTS FOR REGISTRATION OF PHARM. FOR HUMAN USE, GUIDELINES FOR INDUSTRY: STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS 35 (1996), available at http://www.fda.gov/cder/guidance/959fnl.pdf (outlining the unified standard for reporting risk-benefit data from clinical trials to regulatory authorities).
112. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(4)(C) (West Supp. 2008).
113. Id., 21 U.S.C.A. § 355(k)(3)(C)(i)(I), (k)(4)(B).
114. Id. § 905(a), 21 U.S.C.A. § 355 (k)(4)(G)(i).
115. Privacy Act of 1974, 5 U.S.C. § 552a (2006). FDAAA section 905(a) requires compliance with 5 U.S.C. §§ 552 and 552a. See 21 U.S.C.A. § 355(k)(4)(G)(i)(H).
116. C.F.R. § 164.512(i) (2007).
117. See discussion infra Part III.C.1.
118. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(4)(G)(iii) (West Supp. 2008).
119. Id., 21 U.S.C.A. § 355 (k) (4) (G) (ii).
120. Id., 21 U.S.C.A. § 355(k)(3)(C)(i)(I).
121. Id., 21 U.S.C.A. § 355(k) (3)(B) (in).
122. See infra Part III.B.2 for definitions of these terms.
123. See, e.g., Public Health Service Act, 42 U.S.C. §§ 289(a), 300v-l(b) (2000) (authorizing creation of an advisory commission to examine issues in protection of human-subject research and authorizing the Secretary of HHS, based on advice from that commission, to develop appropriate regulations to protect human subjects in certain federally funded research programs).
124. Chen, supra note 33, at 1617.
125. See Mary Shirley, Why Performance Contracts for State-Owned Enterprises Haven't Worked, PUB. POL'Y FOR PRIVATE SECTOR, Aug. 1998, at 1, 1-4, available at http://rru. worldbank.org/documents/publicpolicyjournal/150shirl.pdf (surveying regulatory methods used to privatize 565 state-owned enterprises in thirty-two countries); see also Pierre Guislain & Michael Kerf, Concessions-The Way to Privatize Infrastructure Monopolies, PUB. POL'Y FOR PRIVATE SECTOR Oct. 1995, at 1 (discussing the use of concession contracts as a regulatory tool in nations undergoing privatization of infrastructure industries); Mary M. Shirley, Enterprise Contracts: A Route to Reform?, FIN. & DEV., Sept. 1996, at 6, available at http://www.imf.org/ external/pubs/ft/fandd/1996/09/pdf/ shirley.pdf (discussing privatization and reform of state-owned infrastructure industries).
126. See Klingebiel & Ruster, supra note 53, at 9 (explaining that government strategies to induce private investment in infrastructure have often fallen short of intended objectives because of a lack of a conducive environment for private participation in infrastructure or faulty design of the strategies themselves); see also Smith, supra note 91, at 2-3 (discussing issues facing newly formed regulatory agencies).
127. PHILLIPS, supra note 37, at 693.
128. See Chen, supra note 33, at 1619 (quoting JAMES WILLARD HURST, LAW AND MARKETS IN UNITED STATES HISTORY 21 (1982)).
129. See U.S. Food & Drug Admin., supra note 48.
130. See Neal Learner, FDA's 'Sentinel Initiative 'for Rx Safety Will Rely Heavily on Large Health Plan Databases, AIS's HEALTH BUS. DAILY, June 16, 2008.
131. See, e.g., FDA, March 7 Proceedings, supra note 10, at 66-69 (statement of Dr. Richard Piatt) (describing recent efforts to resolve safety questions surrounding a meningococcal vaccine approved in 2005). Vaccination against meningitis was recommended for all adolescents and, during its first fifteen months, 5.7 million doses of the new vaccine were distributed. During this period, there were fifteen spontaneous reports of Guillain-Barre syndrome, an inflammatory neurological condition that can be lethal or paralyzing. Existing vaccine-safety databases allowed follow-up analysis of 100,000 vaccine doses-far too few to distinguish whether the observed rate of Guillain-Barre was vaccine-related or simply background occurrence of this rare condition. See id. at 66-69. Medicare data would be useless in this context, since the vaccine is used primarily in adolescents.
132. See, e.g., FDA, March 8 Proceedings, supra note 43, at 151 (statement of Dr. Alexander Ruggieri) ("People that have these data sources, which are very rich, could potentially be tempted to pursue possible proprietary ventures with them.").
133. Id. at 144 (statement of Dr. Kelly Cronin).
134. Id. at 144-46; id. at 158 (statement of Dr. Richard Piatt, discussing the general need for resources to ensure prompt system development and the need for clarity about permissible data uses and requirements for approving such uses).
135. FDAAA §§ 905 (d), 908 (a).
136. Id. § 905 (a), 21 U.S.C.A. § 355(k)(3)(c)(iii) (West Supp. 2008).
137. See infra Part II.B.2 for definitions of identified, coded, identifiable, anonymized, and de-identified data.
138. C.F.R. § 46.101-.124 (2007).
139. See Barbara J. Evans & Eric M. Meslin, Encouraging Translational Research Through Harmonization of FDA and Common Rule Informed Consent Requirements for Research with Banked Specimens, 27 J. LEGAL MED. 119, 120 n.5 (2006).
140. See Office for Human Res. Prots., U.S. Dep't of Health & Human Servs., Guidance on Research Involving Coded Private Information or Biological Specimens 6 (2004), http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf [hereinafter OHRP 2004 Guidance].
141. C.F.R. pts. 50, 56 (2008).
142. See discussion infra Part III.C.3.
143. C.F.R. § 164.514(c) (2007).
144. See supra notes 101-09.
145. See Charity Scott, Is Too Much Privacy Bad for Your Health? An Introduction to the Law, Ethics, and HIPAA Rule on Medical Privacy, 17 GA. ST. U. L. REV. 481, 491 (2000) (reporting a 1999 survey showing that ninety percent of Americans believe that sharing health insurance records with other companies is an invasion of privacy).
146. See Lawrence O. Gostin, PUBLIC HEALTH LAW 20-21 (2000).
147. See, e.g., Mark A. Rothstein, Health Privacy in the Electronic Age, 28 J. LEGAL MED. 487, 489 (2007) (discussing surveys indicating public concern with loss of privacy with widespread adoption of electronic health records); Nicolas P. Terry & Leslie P. Francis, Ensuring the Privacy and Confidentiality of Electronic Health Records, 2007 U. ILL. L. REV. 681, 700 (pointing out that systems with less interoperability pose fewer confidentiality and security concerns, but cannot generate the potential health benefits of an interoperable system).
148. FDA, March 7 Proceedings, supra note 10, at 70 (statement of Dr. Richard Platt).
149. See Peter D. Jacobson, Medical Records and HIPAA: Is It Too Late to Protect Privacy?, 86 MINN. L. REV. 1497, 1498 (2002).
150. U.S.C. § 717f(c) (2006).
151. Id. §717f(c)(l)(A).
152. PHILLIPS, supra note 37 at 563-65; see also John Decker, Note, Authorization of Natural Gas Pipeline Construction: Moving Decisions from Regulators to the Marketplace, 12 VA. ENVTL. L.J. 505, 512 (1993).
153. See 15 U.S.C. § 717f(c).
154. Federal Energy Regulatory Commission (FERC) Order No. 234, 47 Fed. Reg. 24,254, 24,266-24,274 (June 4, 1982) (codified as amended at 18 C.F.R. pts 157, 284, 375 (2008)); see Decker, supra note 152, at 515-16.
155. Decker, supra note 152, at 515-16.
156. FDAAA § 905(a), 21 U.S.C.A. § 355(k) (4)(A) (ii) (West Supp. 2008).
157. See id., 21 U.S.C.A. § 355(k)(4).
158. See WORLD BANK, GLOBAL DEVELOPMENT FINANCE 2004, at 161-62 (2004), (discussing how policies, institutions, and regulation can impede movement of capital to developing-country infrastructure), available at http://siteresources. worldbank.org/ GDFINT2004/Home/20177154/GDF-2004%20pdf.pdf; Phil Burns & Antonio Estache, Infrastructure Concessions, Information Flows, and Regulatory Risk, PUB, POL'Y FOR PRIVATE SECTOR, Dec. 1999, at 1, 2, available at http://rru.worldbank. org/Docu-ments/PublicPolicyJournal/203burns.pdf (discussing the importance of being able to forecast, ex ante, "asset values, capital expenditure, depreciation, and operating expenditure profiles, along with the cost of capital, in an attempt to deliver ex ante a fair distribution of returns between shareholders and customers").
159. See JAMES G. HODGE, JR. & LAWRENCE O. GOSTIN, COUNCIL OF STATE & TERRITORIAL EPIDEMIOLOGISTS, PUBLIC HEALTH PRACTICE VS. RESEARCH 7 (2004), available at http://www.cste.Org/pdffiles/newpdffiles/ CSTEPHResRptHodgeFinal.5.24.04.pdf; NAT'L INST, OF HEALTH, U.S. DEP'T OF HEALTH & HUMAN SERVS., PROTECTING PERSONAL HEALTH INFORMATION IN RESEARCH (2004), available at http://privacyruleand research.nih.gov/pdf/HIPAA-Booklet-4- 14-2003.pdf; Paul J. Amoroso &John P. Mid-daugh, Research vs. Public Health Practice: When Does a Study Require IRB Review?, 36 PREVENTIVE MED. 250, 250-53 (2003); Ctrs. for Disease Control & Prevention, supra note 79, at 6-11; James G. Hodge, An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research, 33 J.L. MED. & ETHICS 125, 127 (2005); Dixie E. Snider, Jr. & Donna F. Stroup, Defining Research When it Comes to Public Health, 112 PUB. HEALTH REP. 29 (1997); Ctrs. for Disease Control & Prevention, U.S. Dep't of Health & Human Servs., Guidelines for Defining Public Health Research and Non-Research (1999), http://www.cdc.gov/od/science/regs/hrpp/researchdefinition.htm; Office for Prot. from Research Risks, Office for Human Research Prots., OPRR Guidance on 45 C.F.R. § 46.101(b)(5): Exemption for Research and Demonstration Projects on Public Benefit and Service Programs, http://www.hhs.gov/ohrp/humansubjects/gui- dance/exmpt-pb.htm (last visited Nov. 14, 2008) [hereinafter OPRR Guidance].
160. C.F.R. § 46.102(d) (2007); id. § 164.501.
161. See HODGE & GOSTIN, supra note 159, at 50.
162. C.F.R. § 164.512(b)(l)(i) (2007).
163. HODGE & GOSTIN, supra note 159, at 51.
164. See supra note 159.
165. HODGE & GOSTIN, supra note 159, at 48-50.
166. See, e.g., Jody Freeman, Collaborative Governance in the Administrative State, 45 UCLA L. REV. 1, 1 (1997); Jody Freeman, The Contracting State, 28 FLA. ST. U. L. REV. 155, 164-76 (2000); Jody Freeman, The Private Role in Public Governance, 75 N.Y.U. L. REV. 543, 543 (2000); Morton J. Horwitz, The History of the Public/Private Distinction, 130 U. PA. L. REV. 1423, 1423 (1982); Sidney A. Shapiro, Outsourcing Government Regulation, 53 DUKE L.J. 389, 389 (2003); Note, Public-Private Partnerships and Insurance Regulation, 121 HARV. L. REV. 1367 (2008).
167. FDAAA § 905(a), 21 U.S.C.A. § 355 (k) (4), (k) (4) (A) (ii) (West Supp. 2008).
168. See HODGE & GOSTIN, supra note 159, at 50-51.
169. Ctrs. for Disease Control and Prevention, supra note 79, at subsection titled "Disclosures for Public Health Purposes"; see also Standards for Privacy of Individually Identifiable Health Information, 64 Fed. Reg. 59,918, 59,929 (proposed Nov. 3, 1999) (proposing rules to protect the privacy of individually identifiable health information, including procedures and authorized and required uses of such information).
170. See HODGE & GOSTIN, supra note 159, at 51.
171. See id. at 52.
172. Id. at 51.
173. Id. at 52.
174. Id. at 52-53.
175. See id. at 53.
176. Id. at 49.
177. See Myra Moren et al., Living With the HIPAA Privacy Rule, 32 J.L. MED. & ETHICS 73, 76 (2004) ("In spite of the Privacy Rule's public health exemptions, provider organizations have concerns about releasing data.").
178. The HIPAA Privacy Rule recognizes two major categories of informational linkage: identified health information (which generally requires a signed authorization before it can be used by or disclosed to others) and de-identified health information (which can be disclosed and used without an authorization). However, HIPAA de-identified health information can be coded in a way that allows re-identification or can be supplied without such a code. See 45C.F.R.§ 164.514(b) (2) (i)(R), (c) (2007). Thus, HIPAA in effect has three categories: (1) identified; (2) de-identified but coded; and (3) de-identified and uncoded. De-identifying data under HIPAA requires either certification by a statistician that the risk of re-identification is very small, id. § 164.514(b)(1), or removal of eighteen specific types of information, some of which (such as dates of treatment) is potentially useful in drug safety stuthes, id. §164.514(b). HIPAA's concept of de-identification is potentially more stringent than the concept of "anonymyzation" reflected in other commonly used terminologies. See OHRP 2004 Guidance, supra note 140, at 6-7. For examples of other common terminologies, see INT'L CONFERENCE ON HARMONISATION OF TECH. REQUIREMENTS FOR REGISTRATION OF PHARM. FOR HUMAN USE, GUIDANCE FOR INDUSTRY: E15 DEFINITIONS FOR GENOMIC BIOMARKERS, PHARMACOGENOMICS, PHARMACOGENETICS, GENOMIC DATA AND SAMPLE CODING CATEGORIES 4-7 (2008) [hereinafter ICH GUIDANCE], available at http://www.fda.gov/cber/gdlns/iche15term.pdf; NAT'L BIOETHICS ADVISORY COMM'N, 1 RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS i tbl.l (1999), available at http://www.bioethics.gov/reports/past-commissions/nbac- biologicall.pdf; Pharmacogenetics Working Group, Terminology for Sample Collection in Clinical Genetic Stuthes, 1 PHARMACOGENOMICS J. 101 (2001).
179. See Evans & Meslin, supra note 139, at 126-28.
180. My use of "coded" to imply segregation of code keys from the data user corresponds to terminology developed by the National Bioethics Advisory Commission in 1999. See NAT'L BIOETHICS ADVISORY COMM'N, supra note 178, at i tbl.l. The requirement that code keys be segregated from data users is also consistent with OHRP's current policy for unconsented use of coded specimens and health data under the Common Rule. See OHRP 2004 Guidance, supra note 140, at 2-4. It also is consistent with the HIPAA Privacy Rule's standard for determining whether coded data or specimens can be treated as de-identified; this standard requires nondisclosure of code keys. See 45 C.F.R. § 164.514(c).
181. FDA's new International Conference on Harmonisation (ICH) terminology recognizes two subcategories of coding, one of which segregates code keys from the investigator/data user. The other does not necessarily do so. See ICH GUIDANCE, supra note 178, at 4-5. In ICH terminology, "double-coded" data are coded twice, and the data user has no access to at least one of the code keys. The data user, acting alone, would not be able to re-identify double-coded data, so these data would qualify as "coded" in the sense envisioned in this Article. ICH also recognizes a category of "single-coded" data, for which the investigator/data user may have access to the code key. If the investigator has code-key access, ICH "single-coded" data would not qualify as "coded" under my terminology or under the National Bioethics Advisory Commission terminology or under OHRP's 2004 Guidance, nor could it be considered "de-identified" under the HIPAA Privacy Rule. See id.
182. In other contexts, such as in determining whether informed consent is required under the Common Rule, "identifiable" data are generally understood to mean "identifiable by the data user," for example, the data may be coded, so that the data user does not receive overtly identifying information such as the names or social security numbers of people who are in the database, but the data user has access to the code key and could re-identify the data without enlisting the cooperation of any third parties (such as FDA, the PIO, or a trustee that holds the code key). Under the Common Rule, coded data are not regarded as identifiable by the data user if the data user has no access to the code key. See OHRP 2004 Guidance, supra note 140, at 3-4.
183. See supra note 73.
184. See supra Part LB.
185. See Evans & Meslin, supra note 139, at 127.
186. Id.
187. See HODGE & GOSTIN, supra note 159, at 8.
188. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3)(B)(iii) (West Supp. 2008).
189. FDA's proposed organizational structure includes a research component, so this decision already may have been made. See U.S. FOOD & DRUG ADMIN., supra note 4, at 16.
190. C.F.R. § 164.512(i) (2007).
191. See id. § 164.512(i)(l)(i).
192. An example of an alteration would be to use passive ("opt-out") consent. This involves giving some form of public notice of plans to use data in a particular research study. For example, this might include publishing notice of the research study in newspapers or on websites known to be frequented by persons whose data the researcher wishes to use. The notice describes the data ("all claims submitted to XYZ insurance company between 2004 and 2006"). It then provides a contact address or telephone number to which insured persons can respond if they do not want their data used in that study. If they fail to reply, it is presumed that their data may be used in the study. There are non-U.S. examples of passive consent procedures and at least one reported U.S. example where passive consent was used under HIPAA's alteration provisions. See Benjamin Littenberg & Charles D. MacLean, Passive Consent for Clinical Research in the Age of HIPAA, 21 J. GEN. INTERNAL MED. 207 (2006).
193. C.F.R. § 164.512(i)(2)(ii).
194. Id. § 164.512(i)(2)(ii)(A)(l)-(3).
195. Id. § 164.512(i)(1)(ii)(B)-(C).
196. Ctrs. for Disease Control & Prevention, supra note 79, at 5-6.
197. FDAAA § 905(a), 21 U.S.C.A. § 355(k) (4) (G) (i)(I) (West Supp. 2008).
198. See infra Part III.C.2.
199. C.F.R. § 164.512(i)(2)(iv)(A) (2007).
200. See id. §§ 46.103(b)(3), 46.108(b).
201. See OFFICE OF INSPECTOR GENERAL, U.S. DEP'T OF HEALTH & HUMAN SERVS., INSTITUTIONAL REVIEW BOARDS: A TIME FOR REFORM 9, C-3, C-4 (1998) [hereinafter OIG, IRB A TIME FOR REFORM], available at http://www.oig.hhs.gov/oei/reports/oei-01-97-00193.pdf (indicating that FDA aims to inspect IRBs that operate under FDA's regulations once every five years); OFFICE OF INSPECTOR GENERAL, U.S. DEP'T OF HEALTH & HUMAN SERVS., INSTITUTIONAL REVIEW BOARDS: THEIR ROLE IN REVIEWING APPROVED RESEARCH 3 (1998) [hereinafter OIG, IRB ROLE IN REVIEWING], available at http://www.oig.hhs.gov/ oei/reports/oei-01-97-00190.pdf (estimating that 2,000-5,000 IRBs are in operation at academic medical centers and research institutions in the U.S.); OFFICE OF INSPECTOR GENERAL, U.S. DEP'T OF HEALTH & HUMAN SERVS., PROTECTING HUMAN RESEARCH SUBJECTS 8, 9, 16 (2000) [hereinafter OIG, HUMAN RESEARCH SUBJECTS], available at http://www.oig.hhs.gov/oei/reports/oei-01-97-00197.pdf (finding on-site and spontaneous reviews of IRBs operating under the Common Rule are extremely rare, with only eighteen site visits between 1990 and April 1996; one such visit between April 1997 and May 1998; and ten visits between June 1998 and March 2000).
202. C.F.R. § 164.512(i)(2)(iv)(B) (2007).
203. Id. §164.512(i)(2)(iv)(C).
204. See supra Part II.
205. See GÓMEZ- IBÁÑEZ, supra note 32, at 19 (discussing the need for elaborate procedural safeguards in coercive regulatory decisionmaking).
206. C.F.R. § 164.528 (2007).
207. See id. § 164.512(b) (1)(i).
208. See supra Part III.C.l.
209. See supra notes 193-95 and accompanying text.
210. See supra notes 200-01 and accompanying text.
211. See supra Part III.B.2.
212. See Evans & Meslin, supra note 139, at 138.
213. C.F.R. § 50.3(g) (2008) (informed consent regulation); id. § 56.102(e) (IRB review).
214. In recent years, similar problems have surrounded the status of persons whose tissue specimens are used in FDA-regulated research. See Evans & Meslin, supra note 139, at 138. In 1999, FDA attempted to construe its regulations as requiring informed consent for the use of coded or identified tissue specimens in medical device research. See DIV. OF BIORESEARCH MONITORING, U.S. DEP'T OF HEALTH & HUMAN SERVS., GUIDANCE FOR FDA STAFF: REGULATING In Vitro Diagnostic Device (IVD) Stuthes 4 (1999), http://www.fda.gov/cdrh/ comp/ivdreg.pdf. In doing so, FDA relied on a definition of "human subject," elsewhere in its investigational device exemption regulations, that includes persons "on whose specimen" research is performed. 21 C.F.R. § 812.3(p) (2007). However, there is no definition anywhere in FDA's regulations that includes persons on whose data research is performed. FDA's 1999 Guidance was challenged as amounting to a de facto amendment of FDA's informed consent regulation without proper administrative procedures. Evans & Meslin, supra note 139, at 143-62. In 2006, FDA issued a new Guidance that lets researchers who do not wish to follow the 1999 Guidance voluntarily opt into a regime that lets coded specimens be used in research without informed consent, provided certain steps are taken to protect the privacy of people whose specimens are used. See Guidance on Informed Consent for In Vitro Diagnostic Device Stuthes Using Leftover Human Specimens That Are Not Individually Identified 71 Fed. Reg. 23,924, 23,924-25 (Apr. 25, 2006); OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION & SAFETY, U.S. DEP'T OF HEALTH & HUMAN SERVS., GUIDANCE ON INFORMED CONSENT FOR IN VITRO DIAGNOSTIC DEVICE STUTHES USING HUMAN SPECIMENS THAT ARE NOT INDIVIDUALLY IDENTIFIABLE (2006), http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. This 2006 Guidance, which applies only to medical device research and not to drug research, is generally consistent with OHRP's policy on research use of coded tissue specimens. See OHRP 2004 Guidance, supra note 140. However, FDA did not address the issue of research with coded health data, either in medical device research or more generally.
215. C.F.R. §56 (2008).
216. See, e.g., id. § 312.23(a)(1)(iv) (requiring sponsors' commitment to IRB review of clinical stuthes in the context of investigational new drug applications); id. § 314.50(d) (3) (i) (requiring a statement that each study was conducted in compliance with IRB regulations as part of the application for FDA approval of a new drug).
217. See Evans & Meslin, supra note 139, at 134-38; see also OIG, IRB ROLE IN REVIEWING, supra note 201, at B-1 (estimating that seventy-five percent of research funded by the National Institute of Health is carried out at research institutions that have voluntarily agreed to apply the Common Rule to all research at their institutions).
218. See 45 C.F.R. § 46.101-.124 (2007).
219. See OHRP 2004 Guidance, supra note 140, at 2-4; see also 45 C.F.R. § 46.102(f) (defining human subject as "a living individual about whom an investigator . . . conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information"); id. § 46.101(b)(4) (exempting human subject research involving the collection or study of information "that is publicly available or ... is recorded by the investigator in such a manner that subjects cannot be identified, direcly or through identifiers linked to the subjects" from human subject research protection under the regulations).
220. See Evans & Meslin, supra note 139, at 140-41.
221. OHRP 2004 Guidance, supra note 140, at 4-6.
222. Id.
223. See id. at 3.
224. See id. at 2-6.
225. C.F.R. § 46.101 (b)(4)-(5) (2007).
226. FDAAA § 905(a), 21 U.S.C. § 355 (k) (4) (G) (i) (West Supp. 2008).
227. See Letter from Kristina C. Borror, Div. of Compliance Oversight, Office for Human Research Prots., U.S. Dep't of Health & Human Servs., to Daniel E. Ford, Vice Dean for Clinical Investigation, Johns Hopkins Univ. Sch. of Med., et al., at 4 (July 17, 2007), available at http://www.hhs.gov/ ohrp/detrmJetrs/YR07/ju107d.pdf.
228. See 45 C.F.R. § 46.101 (b) (5).
229. See OPRR Guidance, supra note 159.
230. See OHRP 2004 Guidance, supra note 140, at 3-4.
231. See 45 C.F.R. § 46.116(d). To grant a waiver under the Common Rule, an IRB must determine that: (1) the research involves no more than minimal risk (including privacy related risks); (2) waiver or alteration will not adversely affect rights and welfare of subjects; (3) the research could not practicably be carried out without waiver or alteration; and (4) where relevant, subjects will receive additional pertinent information after participation. Id.
232. See GOSTIN, supra note 146, at 5, 18-20.
233. GÓMEZ-IBÁÑ EZ, supra note 32, at 19.
234. U.S.C. § 355(e) (2006). A complete list of grounds for withdrawal is set forth at 21 C.F.R. § 314.150 (2008).
235. U.S.C. § 355(e); 21 C.F.R. § 314.150(a).
236. U.S.C. § 355(e).
237. Id.; see also Geoffrey M. Levitt et al., Human Drug Regulation, in 2 FUNDAMENTALS OF LAW AND REGULATION 159, 178-79. (David G. Adams et al. eds., 1999).
238. U.S.C. § 355(h) (2006).
239. Levitt et al., supra note 237, at 178.
240. I. Scott Bass, Enforcement Powers of the Food and Drug Administration: Drugs and Devices, in 2 FUNDAMENTALS OF LAW AND REGULATION, supra note 237, at 55, 70-74.
241. U.S.C. § 350a(e)(l) (2006).
242. Safe Medical Devices Act of 1990 § 8, 21 U.S.C. § 360(h)(e)(2006).
243. Bass, supra note 240, at 70.
244. See 21 C.F.R. § 314.80-.81 (2008).
245. See Wood et al., supra note 8, at 1851, 1853.
246. Frontline Interview with Paul Seligman (PBS television broadcast Nov. 4, 2002) (transcript available at http://www.pbs.org/wgbh/pages/frontline/ shows/prescrip-tion/interviews/seligman.html (citing the one to ten percent figure for all adverse events but noting that the system was estimated to detect between one-third to one-half of all serious adverse events).
247. FDAAA § 901(a), 21 U.S.C.A. §355(o)(4) (West Supp. 2008) (letting FDA notify manufacturers of safety information it believes should be included in drug labeling). Following a period of response and discussions with the manufacturer, FDA may order the safety information to be included. See id., 21 U.S.C.A., §355(o)(4)(B)-(D)(E).
248. See id. § 901(b), 21 U.S.C.A. § 355-l(a)(l)-(2) (authorizing FDA to require risk evaluation and mitigation strategies for newly and already approved drugs). FDA may require such strategies to include conditions for marketing and sales, such as restrictions on how, where, and by what type of professional the drug may be prescribed or requirements that patients receive monitoring or testing to manage risks. See 21 U.S.C.A. § 355-1 (f)(3) (West Supp. 2008); see also FDAAA § 902(a), 21 U.S.C.A. § 352 (y) (West Supp. 2008) (allowing drugs to be considered misbranded if manufacturers fail to comply with such restrictions).
249. See FDAAA § 901(a), 21 U.S.C.A. §355(o)(3) (West Supp. 2008) (allowing FDA to require postmarket stuthes or clinical trials of drugs with known or suspected safely problems); id. § 902(a), 21 U.S.C.A. § 352(z) (allowing drugs to be regarded as misbranded if manufacturer fails to conduct required postmarket stuthes).
250. FDA claimed the power to require postmarket stuthes was implicit in the agency's power to enforce the FDCA and to require drug companies to provide data bearing on whether previously granted approvals should be withdrawn. See 21 U.S.C.A. §§ 355(k); 371(a) (West 1999 & Supp. 2008), see also, Levitt et. al, supranote 237, at 179.
251. New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval, 57 Fed. Reg. 13,234, 13,236 (proposed Apr. 15, 1992); New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval, 57 Fed. Reg. 58,942, 58,953-54 (codified as amended at 21 C.F.R. pts 314 & 601).
252. C.F.R. § 314.540 (2008).
253. See Susan Okie, What Ails FDA?, 352 NEW ENG. J. MED. 1063, 1064 (2005).
254. C.F.R. § 50.24 (2008).
255. See supra Parts III.B.1 & III.C.3.
256. C.F.R. § 50.24(a)(1).
257. Id. § 50.24(a) (l)-(7).
258. Id. § 50.24(a)(3).
259. Id. § 50.24 (a) (7) (i).
260. Id. § 50.24(a) (7) (ii).
261. If the experimental product is a drug, the drug's sponsor submits an Investigational New Drug (IND) application to FDA at least thirty days before the trial is set to begin. 21 C.F.R. § 312.40 (2008). FDA has thirty days to object to the IND, after which the IND becomes effective and the clinical trial may begin. If FDA is not satisfied with the proposed plan, FDA can impose a clinical hold that delays the trial until FDA's concerns are satisfactorily addressed. Id. § 312.42.
262. See CDER, MANUAL OF POLICIES AND PROCEDURES, supra note 111, § 6030.8, at 4-5.
263. Ch. 324, 60 Stat. 237 (1946) (codified as amended at scattered sections of 5 U.S.C.).
264. See 5 U.S.C.A. §§ 551-559, 701-706 (West 2007 & Supp. 2008); Carl H. Coleman, Rationalizing Risk Assessment in Human Subject Research, 46 ARIZ. L. REV. 1, 13-17 (2004); Barbara J. Evans, Inconsistent Regulatory Protection Under the U.S. Common Rule, 13 CAMBRIDGE Q. HEALTHCARE ETHICS 366, 372 (2004).
265. Protection of Human Subjects; Informed Consent, 61 Fed. Reg. 51,498, 51,498 (Oct. 2, 1996) (codified as amended at 21 C.F.R. pts. 50, 56, 312, 314, 601, 812, 814).
266. Conduct of Emergency Clinical Research; Public Hearing, 71 Fed. Reg. 51,143, 51,143 (Aug. 29, 2006).
267. See OFFICE FOR HUMAN RESEARCH PROTS., U.S. DEP'T OF HEALTH & HUMAN SERVS., INSTITUTIONAL REVIEW BOARD GUIDEBOOK intro., pt. A (1993), available at http://www.hhs.gov/ohrp/irb/irb-introduction.htm.
268. Id.
269. See generally JAMES H.JONES, BAD BLOOD: THE TUSKEGEE SYPHILIS EXPERIMENT (2d ed. 1993) (detailing the history of the experiment and its consequences).
270. Pub. L. No. 93-348, §§ 201-205, 88 Stat. 342, 348-51 (expired May 18, 1979 pursuant to § 204 (e)).
271. See OFFICE FOR HUMAN RESEARCH PROTS., supra note 267, intro. pt. A.
272. See OIG, IRB A TIME FOR REFORM, supra note 201, at 3; see also ROBERT J. LEVINE, ETHICS AND REGULATION OF CLINICAL RESEARCH 324 (2d ed., 1986).
273. C.F.R. pts. 50, 56 (2008).
274. OIG, HUMAN RESEARCH SUBJECTS, supra note 201, at 8.
275. Both the Common Rule and FDA regulations adopt an identical two-part standard: (1) risks should be minimized to the extent consistent with sound research, and (2) risks should be reasonable in relation to anticipated benefits, if any, to the research subjects and the importance of the knowledge that may reasonably be expected to result from the research. 45 C.F.R. § 46.111 (a) (l)-(2) (2007) (Common Rule); 21 C.F.R. § 56.111 (a)(l)-(2) (2008) (FDA regulations).
276. See NAT'L BIOETHICS ADVISORY COMM'N, 1 ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS ii, iv, xi (2001), http://www.bioethics.gov/ reports/past-commissions/nbac-human-part.pdf (identifying the twin protections of IRB review and informed consent); see also Coleman, supra note 264, at 7, 10 (citing problems with the sufficiency of informed consent as a protective mechanism, and arguing that insufficiency of consent creates a need for more robust procedures for IRB decisionmaking).
277. See 18 C.F.R. § 157.5-.21 (2008).
278. See CDER, MANUAL OF POLICIES AND PROCEDURES, supra note 111, § 6030.8, at 4-5.
279. See id. FDA's review of clinical trials involving an exception from informed consent under 21 C.F.R. § 50.24 includes review by FDA's Division of Scientific Investigation (DSI) of the IRB's plans for community consultation and public disclosure within the communities where the research will be carried out. Id. at 5. However, FDA has never enunciated a clear standard regarding what forms of community consultation will be considered adequate, nor does decisionmaking follow basic norms of notice, transparency of decisions, and opportunities for the public to appeal before research goes forward.
280. For critiques of the PolyHeme trial, see Letter from Senator Charles E. Grassley, Chairman, Senate Comm. on Fin., to Michael Leavitt, Secretary, U.S. Dep't of Health & Human Servs. (Mar. 13, 2006), available at http://finance.senate.gov/ press/Gpress/2005/prg031306.pdf; see also Karla F.C. Holloway, Accidental Communities: Race, Emergency Medicine, and the Problem of PolyHeme, AM. J. BIOETHICS, May 2006, at 7, 12-16 (citing the trial as an example of systematic racial bias in prehospital emergency medical care); Ken Kipnis et al., An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme Trial, AM. J. BIOETHICS, May 2006, at 18, 18 (claiming that "there is a serious etfiical flaw" in the trial).
281. Letter from Senator Grassley, supra note 280, at 2.
282. Press Release, U.S. Senate Comm. on Fin., Grassley Questions FDA's Sanction of Blood Substitute Study Without Informed Consent 2 (Feb. 23, 2006), available at http://www.senate.gov/~finance/press/Gpress/2005/prg022306a. pdf.
283. See Charles Natanson et al., Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death, 299 JAMA 2304, 2307 tbl.2 (2008) (discussing risks of PolyHeme and four other blood substitutes); id. at 2310 (pointing out that FDA let PolyHeme trials go forward despite adverse events in previous trials of other blood substitutes).
284. See Letter from Senator Grassley, supra note 280, at 2.
285. See Press Release, U.S. Senate Comm. on Fin., supra note 282, at 1.
286. See Natanson et al., supra note 283 at 2307, 2310 (indicating some increase in the relative risk of mortality and serious adverse events, although noting questions about the statistical significance of these increased risks).
287. See U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., Public Hearing on Emergency Research and Human Subject Protections (Oct. 11, 2006) http://www.fda.gov/ohrms/dockets/dockets/06d0331/06d-0331-tr00001- vo14.rtf; see also U.S. Food & Drug Admin., U.S. Health & Human Servs., 2006D-0331: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, Exception from Informed Consent Requirements for Emergency Research (Jan. 31, 2007), http:// www.fda.gov/ohrms/dockets/dockets/ 06d0331/1.htm (cataloguing documents relevant to the hearings including comments from consumers and other concerned parties).
288. Sandra Sells, FDA Comment No. EC30 (Sept. 21, 2006), http://www.fda.gov/ ohrms/dockets/dockets/06d0331/06D-0331-EC30.htm.
289. Lillian Kehoe, FDA Comment No. EC11 (Sept. 11, 2006) http://www.fda.gov/ ohrms/dockets/dockets/06d0331/06D-0331-EC11.htm.
290. The field of bioethics, as it developed in the 1950s and 1960s, drew heavily on a Kantian, atomistic concept of autonomy that conceives individuals as self-reliant, self-governing, and individualistic. See ALFRED I. TAUBER, PATIENT AUTONOMY AND THE ETHICS OF RESPONSIBILITY 13 (2005). The concept is similar to Fallon's "ascriptive" autonomy, which entails each person's sovereignty over his or her moral choices. Richard H. Fallon, Jr., Two Senses of Autonomy, 46 STAN. L. REV. 875, 890-93 (1994). At the birth of bioethics, the field was principally concerned with the rights of patients as against physicians in a paternalistic healthcare system; strong assertions of individual autonomy were an antidote to imbalances of power in that relationship. See TAUBER, supra at 15-16; see also DAVID J. ROTHMAN, STRANGERS AT THE BEDSIDE 258 (1991) ("Patients are also likely to be sparing with the deference and trust they accord to physicians . . . , reserving for themselves critical decisions about treatment."). Balancing individual rights against broader public interests has not been a major focus of bioethical thought. The notion, "Individuals are free to enjoy their rights, so long as they do not encroach on the rights of others," embothes an atomistic concept of autonomy, as Tauber has noted. Tauber, supra at 119 (citing GRACE CLEMENT, CARE, AUTONOMY, AND JUSTICE (1996)). Yet the atomistic concept of autonomy poses a problem: it offers no account of why and when the moral sovereignty of the individual should yield to public interests. It leaves policymakers with Aleinikoff's "external-scale" problem-the search for an external, objective set of values by which to balance competing interests. See T. Alexander Aleinikoff, Constitutional Law in the Age of Balancing, 96 YALE L.J. 943, 962-63, 975 (1987). The atomistic concept of autonomy, embraced by 1960s-era bioethicists, has no internal scale. Only more recently, after 1980, have bioethicists begun to explore alternatives, such as a view of autonomy as "not merely an internal, or psychological characteristic but also an external, or social one," with individuals achieving autonomy in cooperation rather than in isolation. See TAUBER, supra at 120-22 (quoting CLEMENT, supra, at 22). This latter view eventually may allow bioethicists to wield questions that require balancing of individual and societal interests. However, such inquiries remain poorly developed in the field of bioethics at this time.
291. See, e.g., J. Lazarou et al., Incidence of Adverse Drug Reactions in Hospitalized Patients, 279 JAMA 1200, 1200 (1998) (estimating that 0.32% of prescriptions written kill the patient, placing adverse drug reactions between the fourth and sixth leading causes of death at U.S. hospitals; another 6.7% of prescriptions result in injuries serious enough to put the patient in the hospital or prolong the stays of already hospitalized patients).
292. See supra note 201 and accompanying text.
293. See, e.g., GÓMEZ- IBÁÑEZ, supra note 32, at 12-13, 30-32; Chen, supra note 33, at 1628.
294. See Guislain & Kerf, supra note 125, at 1, 3-4. When contract-based regulation is implemented in foreign settings, it sometimes involves direct negotiation of regulatory contracts between the private infrastructure operator and the government, without necessarily creating a special-purpose industry regulatory agency to oversee negotiation and ongoing oversight of the contract.
295. FDAAA § 905(a), 21 U.S.C.A. § 355(k)(3)(C)(v), (k)(4)(F) (West Supp. 2008).
296. See, e.g., 21 U.S.C. § 371 (2006).
297. See, e.g., GÓMEZ- IBÁÑEZ, supra note 32, at 28, tbl.2.1 (comparing the two approaches).
298. See Chen, supra note 33, at 1628 (citing Oliver Hart & John Moore, Incomplete Contracts and Renegotiation, 56 ECONOMETRICS 755 (1988)).
299. See id. (citing GÓMEZ- IBÁÑEZ, supra note 32, at 11-12, 27-30).
300. See id.
301. See id. at 1649.
302. Id. at 1649-50.
303. See generally Shirley, supra note 125 (surveying the effectiveness of contract-based regulation in 565 infrastructure privatizations).
304. GÓMEZ-IBÁÑ EZ, supra note 32, at 15; Chen, supra note 33, at 1620-21; Smith & Wellenius, supra note 93, at 2-3.
305. See, e.g., Chen, supra note 33, at 1631 (noting the public utility regulation has been criticized as raising questions of "indeterminacy and inefficiency").
306. Cf. id. at 1620-21 (discussing the changes in infrastructure priorities from the nineteenth to twentieth centuries).
307. Id. at 1633, 1650.
308. GÓMEZ-IBÁÑ EZ, supra note 32, at 353-56; see also Chen, supra note 33, at 1631-33.
309. Chen, supra note 33, at 1669.
310. See supra Part III.B.2.
311. See supra Part LA.
312. Smith, supra note 91, at 1.
313. An arm's length relationship between regulatory decisionmakers and regulated companies is so basic that its absence gives rise to the presumption that a legitimate regulatory framework is not in place. See, e.g., Robert Bacon, A Scorecard for Energy Reform in Developing Countries, PUB. POL'Y FOR THE PRIVATE SECTOR, Apr. 1999, at 2 box 1, available at http://rru. worldbank.org.docurnents/publicpolicyjoumal/175 bacon.pdf (surveying 115 developing countries to ascertain whether they had or had not instituted effective regulatory frameworks based on six criteria-such as whether the nations had passed regulatory laws and whether they had completed various restructuring and privatization steps within the regulated industries-and applying a single criterion to judge whether appropriate regulatory decisionmaking bodies were in place: was there a regulator that was separate from the regulated companies and from political authorities?).
314. Cf Richard Shelby, Accountability and Transparency: Public Access to Federally Funded Research Data, 37 HARV. J. ON LEGIS. 369, 370 (2000) ("Transparency and accountability in government are two principles crucial to securing public trust.").
315. See Smith, supra note 91, at 1.
316. U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., FDA Protects the Public Health; Ranks High in Public Trust (Feb. 2002), http://www.fda.gov/ opacom/factsheets/justthefacts/lfda.pdf (reporting results of an independent survey, conducted in 1999, which found high levels of public trust in FDA).
317. COMM. ON THE ASSESSMENT OF THE U.S. DRUG SAFETY SYS., supra note 13, at 17-18.
318. OFFICE OF INSPECTOR GENERAL, U.S. DEP'T OF HEALTH & HUMAN SERVS., THE FOOD AND DRUG ADMINISTRATION'S OVERSIGHT OF CLINICAL TRIALS, 10-18 (2007), available at http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf (discussing factors, including resource and data constraints, that undercut FDA's ethical oversight of clinical trials).
319. Office for Human Research Prots., U.S. Dep't of Health & Human Servs., Staff Directory, http://www.hhs.gov/ohrp/about/staff.html (last visited Nov. 14, 2008).
320. Nat'l Inst. of Health, U.S. Dep't of Health & Human Servs., NIH Overview, http://www.nih.gov/about/NIHoverview.html (last visited Nov. 14, 2008).
321. See supra note 201 and accompanying text.
322. Ron Stein, Medical Privacy Law Nets No Fines, WASH. POST, June 5, 2006, at A1.
323. Fed. Energy Regulatory Comm'n, U.S. Dep't of Energy, Frequently Asked Questions, http://www.ferc.gov/o12faqpro/default.asp?Action=Q&ID=17 (last visited Oct. 6, 2008) (reporting a full year 2006 budget of $220 million and 1295 employees).
324. Office of Managing Dir., Fed. Commc'ns Comm'n, 2007 Annual FCC Employee Survey Responses 2, http://hraunfoss.fcc.gov/edocs-public/attachmatch/ DOC-280549Al.pdf (last visited Nov. 14, 2008) (reporting 1814 employees as of November 2007).
325. U.S.C. § 3730(b)-(d) (2006).
326. See Dan McGuire & Mac Schneider, Health Care Fraud, 44 AM. CRIM. L. REV. 633, 389 (2007) ("Qui tarn actions are a growing method of healthcare fraud enforcement. In 1993 there were 132 qui tam actions and by 2003 this number had jumped to approximately 3260.").
327. U.S.C. §3730 (2006).
328. See id. § 3730(d).
329. Antonio Estache, Designing Regulatory Institutions for Infrastructure-Lessons from Argentina, PUBLIC POLICY FOR THE PRIVATE SECTOR, May 1997, at 1, available at http:// rru.worldbank.org/documents/ publicpolicyjoumal/114estac.pdf.
330. See, e.g., Michael D. Green, Statutory Compliance and Tort Liability: Examining the Strongest Case, U. MICH. J.L. REFORM 461, 476 (1997) ("FDA is woefully underfunded for its mandate, which includes regulatory oversight of products that account for more than twenty-five percent of all American consumer purchases .... 'It is glaringly apparent that FDA cannot now execute all of its statutory responsibilities within the limitations of existing resources.'" (quoting ADVISORY COMM. ON FOOD & DRUG ADMIN., FINAL REPORT 11 (1991))); Alicia Mundy, Congress Presses EDA on Budget Woes, Investigative Arm, WALL ST. J., June 11, 2008, at A19 ("Members of Congress are questioning the management and priorities of [FDA's criminal investigation wing], in the context of FDA budget problems.").
331. Katja Sander Johannsen et al., Dimensions of Regulatory Independence-A Comparative Study of the Nordic Electricity Regulators 6 (unpublished manuscript), available at http://www.elforsk-marketdesign.net/archives/ 2003/conference/ papers/13-pedersen-larsen.pdf (comparing regulatory funding in Nordic countries); Kathleen Riviere-Smith, Funding the Regulator 4-7 (Oct. 8, 2003), http://www. oocur.org/Proceedings/Presentations/RiviereSmithl.pdf (detailing regulatory funding in the Bahamas).
332. See supra notes 312-14 and accompanying text.
333. See generally Bruce N. Kuhlik, Industry Funding of Improvements in FDA's New Drug Approval Process: The Prescription Drug Use Fee Act of 1992, 47 FOOD & DRUG L.J. 483 (1992) (discussing FDA's use of user fees).
334. See David A. Kessler & David V. Vladeck, A Critical Examination of FDA's Efforts to Preempt Failure-to-Wam Claims, 96 GEO. L.J. 461, 485-86 (2008).
335. See 18 C.F.R. § 382.101, .202 (2008) (establishing procedures for "calculating and asserting annual charges to reimburse the United States for . . . costs incurred by [the FERC]," specifically the costs of the administration of natural gas regulation, "assessed against each natural gas pipeline company" in accordance with the proportion of regulated gas it transported).
336. See id. § 154.402 ("[A] natural gas pipeline company may adjust its rates, annually, to recover from its customers annual charges assessed by the Commission under part 382 of this chapter.").
337. A fifteen dollar fee may in fact be conservative for today's travel industry, as, for instance, Delta and United Airlines both now charge a twenty-five dollar fee for reservations made by phone. Delta Airlines Official Website, http://delta.com (last visited Nov. 14, 2008); United Airlines Official Website, http://united.com (last visited Nov. 14, 2008).
338. Chen, supra note 33, at 1624 (defining asset specificity as "the relative difficulty of transferring assets intended for use in one transaction to other uses").
339. See supra note 135 and accompanying text (discussing limitations of Congress' appropriations for the Sentinel System).
340. See supra Part LB (discussing FDA's duty to protect the privacy of individuals in the Sentinel System).
341. Anand Chandavarkar, Infrastructure Finance: Issues, Institutions, and Policies (The World Bank Policy Research Working Paper No. 1374, 1994), available at http://www-wds.worldbank.org/external/default/ WDSContentServer/IW3P/IB/1994/11/01/0 00009265-3970716141904/Rendered/PDF/multi- page.pdf (analyzing the distinctive features of infrastructure financing and the principle issues for policymakers to address); see also Klingebiel & Ruster, supra note 53 (presenting case stuthes of infrastructure financing facilities at various stages of development).
342. See PHILLIPS, supra note 37, at 438-41 (discussing permissible discrimination among user classes in utility rate design); William H. Lawrence & John H. Minan, Financing Solar Energy Development Through Public Utilities, 50 GEO. WASH. L. REV. 371, 407 (1982).
343. See Lawrence & Minan, supra note 342, at 407.
344. See generally INFRASTRUCTURE NETWORK, THE WORLD BANK, INFRASTRUCTURE: LESSONS FROM THE LAST TWO DECADES OF WORLD BANK ENGAGEMENT (2006) (discussing efforts to design infrastructure financing in various countries since the late 1980s).
345. Klingebiel & Ruster, supra note 53, at 1 n.1.
346. See id.
347. See, e.g., Mateen Thobani, Private Infrastructure, Public Risk, FIN. & DEV., Mar. 1999, at 50, 53, available at http://www.imf.org/external/pubs/ft/fandd/1999/03/ pdf/thobani.pdf ("Whether the potential benefits of private provision of infrastructure are fully realized depends on how governments allocate the risks.").
348. See id.
349. See Klingbiel & Ruster, supra note 53, at 4.
350. See Posner, supra note 34, at 549.
351. Chen, supra note 33, at 1620.