Recent developments in health law

Journal of Law, Medicine and Ethics

Volumn 35, Issue 2, 2007, Pages 329-339

  Benson, Eric ^a   Hickey, Brendan ^a   Wong, Katherine ^a  

^a HARVARD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; HEALTH CARE POLICY; HEALTH INSURANCE; HUMAN; LEGAL ASPECT; UNITED STATES;

CALIFORNIA; HEALTH CARE REFORM; HUMANS; INSURANCE, HEALTH; MASSACHUSETTS;

EID: 34249315468     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2007.00144.x     Document Type: Article

References (150)

1. G. W. Bush The State of the Union January 23, 2007, available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2007_record&docid= cr23ja07-120 last visited March 20, 2007).
2. See e.g., J. Edwards Universal Health Care through Shared Responsibility February 5, 2007, available at http://johnedwards.com/about/issues/health-care- overview.pdf (last visited February 13, 2007). Edwards's "shared responsibility" proposalrelies on an individual mandate, government subsidies, employer assessments, and purchasing pools, all of which are central elements of both the Massachusetts and California plans. See also D. Broder Health Coverage's Momentum Washington Post, February 4, 2007, at B07, available at http://www.washingtonpost.com/wp-dyn/content/ar-ticle/2007/02/02/ AR2007020201547.html last visited March 20, 2007).
3. Schwarzenegger consulted experts on the Massachusetts reforms to guide development of his proposal. J. Krasner California's Health Care Plan Looks Familiar Boston Globe, January 11, 2007, at D1, available at http://www.boston.com/business/healthcare/articles/2007/01/11/ califs_healthcare_plan_looks_familiar/ last visited March 20, 2007).
4. P. Belluck Massachusetts Could Serve as a Guide in California's Health Insurance Bid New York Times, January 10, 2007, available at http://www.nytimes.com/2007/01/10/us/10mass.html?ex=1170910800&en= c567226b2ee52b40&ei=5070 last visited March 20, 2007 article is password protected).
5. Members include the state secretary of Administration and Finance, the executive director of the state Group Insurance Commission, the state director of Medic-aid, the commissioner of the state Division of Insurance, a health economist, an actuary, a representative of small business, a representative of a health consumer organization, an employee health benefit specialist, and a representative of organized labor. Mass. Gen. Laws ch. 176Q, § 2(b) (2006).
6. Mass. Gen. Laws ch. 111M, § 2(b) (2006).
7. Id.
8. The Connector will set affordability standards later this spring. Commonwealth Health Insurance Connector Authority, "Timetable: Process for Developing Regulations," January 11, 2007, available at http://www.mass.gov/Qhic/docs/Time-table%20- %20Process%20for%20Developing%20Regs.xls last visited March 20, 2007).
9. Mass. Gen. Laws ch. 176Q, §3(a)(5) (2006).
10. Mass. Gen. Laws ch. 111M, § 2(a) (2006).
11. Commonwealth Health Insurance Connector Authority 3rd Tier Product Specifications February 6, 2007, available at http://www.mass.gov/Qhic/docs/3rd- Tier%20Specifcations.doc (last visited March 20, 2007).
12. Commonwealth Health Insurance Connector Authority Policy Committee Data: MCC Overview January 19, 2007, available at http://www.mass.gov/Qhic/docs/ Policy%20Committee%20Data%20(01-19-06).xls last visited March 20, 2007).
13. Mass. Gen. Laws ch. 175, § 108(2)(a)(3) (2006); Mass. Gen. Laws ch. 176A, § 8Z (2006); Mass. Gen. Laws ch. 176B, § 4Z (2006); Mass. Gen. Laws ch. 176G, § 4R (2006).
14. Mass. Gen. Laws ch. 176J, § 10 (2006).
15. Mass. Gen. Laws ch. 176Q, § 4 (2006).
16. Massachusetts Division of Insurance and Market Merger Special Commission Massachusetts Division of Insurance and Market Merger Special Commission December 26, 2006, at 10, available at http://www.mass.gov/Eoca/docs/doi/ Legal_Hearings/Non-Grp_SmallGrp/FinalReport_12_26.pdf last visited March 20, 2007.
17. Mass. Gen. Laws ch. 118H (2006). FPL is currently $9,800 for an individual. See 71 Federal Register 3848-3849.
18. Mass. Gen. Laws ch. 118H, § 6 (2006).
19. Mass. Regs. Code tit. 956, § 3.11 (H)(2) (2006).
20. Commonwealth Health Insurance Connector Authority, Press Release, Connector Authority Expands Access to Health Coverage, January 23, 2007, at 1, available at http://www.mass.gov/Qhic/docs/worcester_pr_1.23.doc last visited March 20, 2007) (hereinafter cited as Commonwealth).
21. R. Day, Operations Report by Deputy Director Rosemarie Day, Paper presented at the Massachusetts Connector Board meeting, Boston, MA, February 8, 2007.
22. Massachusetts Executive Office of Health and Human Services, Press Release, Survey Reveals 88,000 Reduction Among State's Uninsured, August 28, 2006, at 1, available at http://www.mass.gov?pageID=pressreleases&agId= Eeohhs2&prModName=eohhspressrelease&prFile= pr_060828_uninsured_numbers_reduced.xml last visited March 20, 2007) (hereinafter cited as Massachusetts).
23. Mass. Gen. Laws ch. 149, § 188 (2006); Mass. Gen. Laws ch. 151F, § 2 (2006).
24. Mass. Regs. Code tit. 114.5, § 16 (2006).
25. Mass. Gen. Laws ch. 149, § 188(c)(10) (2006).
26. Mass. Gen. Laws ch. 151F, § 2 (2006).
27. Mass. Gen. Laws ch. 118G, §§ 1, 18B(b) (2006).
28. Mass. Gen. Laws ch. 175, § 110 (2006 Mass. Gen. Laws ch. 176A, § 8 1/2 (2006); Mass. Gen. Laws ch. 176B, § 3B (2006); Mass. Gen. Laws ch. 176G, § 6A (2006).
29. Health Access Preliminary Analysis: Governor Schwarzenegger's Health Care Proposal January 17, 2007, at 1, available at http://www.health-access.org/ advocating/docs/Preliminary%20Analysis%20of%20Gov's%20Health%20Care%20Proposal. pdf last visited March 20, 2007).
30. California Office of the Governor Governor's Health Care Proposal January 8, 2007, at 6, available at http://www.health-access.org/advocating/docs/ Governor's%20HC%20Proposal.pdf last visited March 20, 2007 hereinafter cited as California).
31. Id., at 5.
32. Id., at 4, 5.
33. Id., at 4.
34. Id., at 7.
35. Id., at 8.
36. Id.
37. Id., at 4; see Health Access, supra note 29, at 3.
38. Healthy Actions" programswill provide rewards such as premium reductions or gym memberships to people who participate in "evidence-based practices and behaviors that have been shown to both reduce the burden of disease and are cost effective." See California Office of the Governor, supra note 30, at 1, 8.
39. Id., at 7.
40. Id., at 4.
41. Id., at 8, 9.
42. Health Access, "Massachusetts' Health Care Law: Model, Mirage, or Momentum?" June, 2006, at 12, available at http://www.health-access.org/ expand-ing/docs/MassCalHAFReportFinal.pdf last visited March 20, 2007). ("The scope of the problem is almost twice as great in California, where nearly 1 in 5 residents are uninsured, as opposed to in Massachusetts, which is closer to 1 in 10.").
43. Id., at 3. (A more expansive proposal "was pending in a ballot measure for which signatures were already collected by a large coalition of health care and consumer advocates.").
44. See Broder, supra note 2. ("As he seeks the GOP nomination, Romney is touting his plan for universal coverage.").
45. Massachusetts Executive Office of Health and Human Services Mass Health Section 1115 Waiver Amendment May 1, 2006, at 3, available at http://www.mass.gov/Eeohhs2/docs/eohhs/cms_waiver_2006/amendment.pdf (last visited March 21, 2007). California's waiver is good until 2010. Centers for Medicare and Medicaid Services, "Details for California Medi-Cal Hospital Uninsured Care 1115 Waiver," November 8, 2005, available at http://www.cms.hhs.gov/MedicaidStWaivProgDemoPGI/MWDL/itemdetail.asp?flterType= none&flterByDID=0&sortByDID=3&sortOrder=ascending&itemID= CMS042428 last visited March 20, 2007).
46. A Healthy Blog California Dreamin' II Health Care for All Web site, January 10, 2007, available at http://blog.hcfama.org/?p=758? last visited February 13, 2007).
47. Health Access, supra note 42, at 8.
48. Id., at 11.
49. A. Dembner A. Dembner Boston Globe, January 30, 2007, available at http://www.boston.com/news/local/arti-cles/2007/01/30/ 200000_may_need_to_get_more_insurance/ last visited March 21, 2007). (The consumer advocacy group Health Care for All called for more benefits while the Massachusetts Association of Health Plans, an industry group, called for fewer restrictions).
50. Mass. Gen. Laws ch. 175, § 110 (2006); Mass. Gen. Laws ch. 176A, § 8 1/2 (2006); Mass. Gen. Laws ch. 176B, § 3B (2006); Mass. Gen. Laws ch. 176G, § 6A (2006).
51. T. Wallack and M. Hollmer Light Fines May Hamper New Health Law Boston Business Journal, November 10, 2007, available at http://boston.bizjournals.com/ boston/stories/2006/11/13/story4.html last visited March 21, 2007).
52. The Employee Retirement Income Security Act (ERISA) is a federal statute which preempts state laws that require employers to offer specified levels of employee benefits. California's penalty is very similar to a Maryland penalty recently found to be preempted by ERISA. See Retail Industry Leaders Association v. James D. Fielder, 4th Cir. 2007), No. 06-1840, No. 06-1901, 2007 U.S. App. LEXIS 920, available at http://pacer.ca4.uscourts.gov/opinion.pdf/061840.P.pdf last visited March 21, 2007). Because Massachusetts' employer assessment is so small, it is less likely to be preempted by ERISA.
53. Mass. Gen. Laws ch. 176M, §§ 3, 4, 5 (2006).
54. See Health Access, supra note 42, at 4.
55. California Medical Association History of Health Coverage in California January 2007, available at http://www.cma-net.org/upload/ health_coverage_history.pdf last visited February 13, 2007); see Health Access, supra note 42, at 4 (in California, for-profit insurers "dominate the market").
56. Massachusetts House of Representatives Register of Seasonably Filed Petitions January 2007, at 21, 88, 120, and 143, available at http://www.mass.gov/legis/07dockets.pdf last visited March 21, 2007).
57. See e.g., E. McNamara Insurance Law Far from Cure Boston Globe, January 31, 2007, available at http://www.boston.com/news/local/articles/2007/01/31/in- surance_law_far_from_cure/ last visited March 21, 2007 see also Dembner, supra note 49.
58. Commonwealth, supra note 20, at 1; Day supra note 21.
59. Massachusetts, supra note 22, at 1.
60. California, supra note 30, at 2.
61. K. Drum Universal Healthcare in California Washington Monthly, January 9, 2007, available at http://www.washingtonmonthly.com/archives/individ-ual/ 2007_01/010528.php last visited March 21, 2007). ("Tax and budget issues require a two-thirds majority to pass.").
62. University and Small Business Patent Procedures Act, 5 U.S.C. §§ 200-212, 1980.
63. Editorial Innovation's Golden Goose The Economist, U.S. Ed., December 14, 2002.
64. J. Fraser and A. J. Stevens Understanding the Importance of Bayh Dole Euromoney Institutional Investor, December 1, 2005.
65. In 1979, only five percent of the government's 28,000 patents were licensed to industry, but since 1991, universities have executed 43,862 licenses. Moreover, the number of licenses per year has steadily risen during that time from 1,229 in 1991 to 4,783 in 2004. Association of University Technology Managers, "AUTM Licensing Survey, FY 2004: A Survey Summary of Technology Licensing (and Related) Performance for U.S. Academic and Non-profit Institutions, and Technology Investment Firms," 2005, at 24, available at http://www.autm.net/events/File/04AUTMSurveySum-USpublic.pdf last visited March 19, 2007).
66. C. Leaf and D. Burke The Law of Unintended Consequences Fortune, September 19, 2005.
67. The incomes from these licenses have also increased rapidly from $218 million in 1991 to $1,385 million in 2004: marking the fifth consecutive year of over $1 billion in licensing revenues. Eighty percent of this revenue comes from running royalties from product sales. See AUTM, supra note 4, at 24.
68. AUTM, supra note 4, at 14.
69. The Bayh-Dole Act requires this money be spent on "research and education," but this is not defined and therefore covers an extremely broad array of expenditures. See Leaf and Burke, supra note 5.
70. Commission on Intellectual Property Rights Integrating Intellectual Property Rights and Development Policy 2002, at 38, available at http://www.iprcom-mission.org/papers/pdfs/final_report/CIPRfullfnal.pdf last visited March 19, 2007).
71. Médecins Sans Frontiéres Médecins Sans Frontiéres 9th ed., July 2006, at 5, available at http://www.accessmed- msf.org/documents/untang-lingtheweb%209.pdf last visited March 19, 2007).
72. Universities Allied for Essential Medicine Philadelphia Consensus Statement on University Policies for Health-Related Innovations November 13, 2006, available at http://consensus.essentialmedicine.org last visited March 21, 2007 article is password protected).
73. Id.
74. A. Kapczynski, S. Chaifetz, Z. Katz, and Y. Benkler Addressing Global Health Inequities: An Open Licensing Approach for University Innovations Berkeley Technology Law Journal 20, no. 2 (2005 1031-1114, at 1036.
75. Id.
76. P. Kelly Choosing the Greater Good in Promotion of UW Intellectual Properties University Week, (University of Washington, Seattle) January 4, 2007. The resolution recommends that the UW "affirm that its primary goal in technology transfer is to maximize the worldwide use and societal benefit of its research and technology.".
77. D. A. Chokshi Improving Access to Medicines in Poor Countries: The Role of Universities PLoS Med 3, no. 6 (2006): e136, 2006, available at http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/ journal.pmed.0030136 last visited March 19, 2007).
78. The leaders of universities have not yet been able to come together around a different approach," says Leahy. "Regardless of how it is achieved, I believe that increasing the availability of the medical innovations that come from publicly-funded research centers is a sound solution to a pressing global health concern." Universities Allied for Essential Medicine, Press Release, Senator Leahy Introduces University Licensing Bill, October 6, 2006, available at http://www.essentialmedi-cine.org/?p=45 last visited March 19, 2007).
79. Public Research in the Public Interest Act of 2006 (senate bill s. 4040), introduced September 29, 2006, available at http://thomas.loc.gov/cgi-bin/ query/z?c109:S.4040 The Benefits of Medical Research and the Role of the NIH 106th Congress 2nd Session: 27, at 4, May 17, 2000, available at http://hsc.utoledo.edu/research/nih_research_benefits.pdf last visited March 20, 2007).
80. World Health Organization Equitable Access to Essential Medicines: A Framework for Collective Action 2004, at 1, available at http://whqlibdoc.who. int/hq/2004/WHO_EDM_2004.4.pdf last visited March 20, 2007).
81. See Kapczynski et al., supra note 13, at 1046.
82. See World Health Organization, supra note 25, at 1.
83. Médecins Sans Frontieres Médecins Sans Frontieres 2003, at 48, available at http://www.accessmed-msf.org/documents/procurementreport.pdf last visited March 20, 2007).
84. Over 75 percent of the world's population live in low- and low-middle income countries. See The World Bank Over 75 percent of the world's population live in low- and low-middle income countries. See The World Bank April 2006, at 2.1, available at http://devdata.world-bank.org/wdi2006 last visited March 19, 2007).
85. Médecins Sans Frontiéres, supra note 10, at 5.
86. Central and South America accounted for 2.3 percent of sales, and Central and Eastern Europe 0.9 percent. Sales figures for each of these regions include upper-middle income countries that would not be affected by the legislation (e.g., South Africa, Taiwan, Hong Kong, Korea, Argentina, and the Czech Republic). See Pharmaceutical Research and Manufacturers of America (PhRMA), "Pharmaceutical Industry Profile 2006," March 2006, at 50, available at http://www.phrma.org/fles/2006%20Industry%20Profle.pdf last visited March 19, 2007) (hereinafter cited as PhRMA). See also The World Bank, supra note 19.
87. Congress of the United States, Congressional Budget Office Research and Development in the Pharmaceutical Industry October 2006, at 53, available at http://www.cbo.gov/ftpdocs/76xx/doc7615/10-02-DrugR-D.pdf last visited March 19, 2007) (hereinafter cited as Congress).
88. Id.
89. PhRMA, supra note 31, at 45.
90. Congress, supra note 32, at 37.
91. I. Cockburn and R. Henderson Publicly Funded Science and the Productivity of the Pharmaceutical Industry in A. Jaffe, J. Lerner and S. Stern, eds., Innovation Policy and the Economy vol. 7 (Cambridge : MIT Press, 2001 at 17.
92. The Human Development Index (HDI) is based on life expectancy, literacy, education, and standard of living. It is used by the United Nations Development Programme in its annual Human Development Report and is available at http://hdr.undp.org/ last visited March 19, 2007).
93. K. Outterson Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets Yale Journal of Health Policy, Law, and Ethics 5, no. 1 (2004 at 2.
94. See Public Research in the Public Interest Act, supra note 18, at §4(e)(2). See also World Trade Organization General Council, "Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health," August 30, 2003, at 2(b)(ii), available at http://www.wto.org/English/tratop_e/trips_e/implem_para6_e.htm last visited March 19, 2007).
95. Outterson, supra note 38, at 57.
96. See The World Bank, supra note 29, at 4.
97. See J. M. Mueller Taking Trips to India - Novartis, Patent Law, and Access to Medicines," New England Journal of Medicine 356, no. 6 (2007): 541-543. See also "A Novel Prescription The Economist, November 9, 2006.
98. P. Bardhan China, India Superpower? Not so Fast¡ Despite Impressive Growth, the Rising Asian Giants Have Feet of Clay Yale Global, October 25, 2005, available at http://yaleglobal.yale.edu/display.article?id=6407 March 19, 2007).
99. Most likely, the parties will contractually stipulate that these royalties go to the pharmaceutical company and are counted as sales revenue for the purposes of university royalty payments. This would result in royalty revenues being slightly impacted proportionate to industry sales revenues.
100. T. F. Willey Association of University Technology Managers Licensing Survey, FY 1991-FY 1995: Five-Year Survey Summary 1996, at 6.
101. N. Freitag Federal Food and Drug Act Violations American Criminal Law Review 41, no. 2 (2004 at 647, 667-669.
102. Dietary Supplement Health and Education Act (DSHEA) of 1994, 42 U.S.C. § 262 (2000). Before enactment of DSHEA, dietary supplements were subject to the same regulatory requirements as other foods. See U.S. FDA, Overview of Dietary Supplements, January 3, 2007, available at http://vm.cfsan.fda.gov/ ∼dms/ds-oview.html last visited January 26, 2007).
103. H. Miller and D. Longtin Death by Dietary Supplement Policy Review, no. 102, August and September 2000, available at http://hoover.org/publications/ policyre-view/3486962.html (last visited February 7, 2007). See also Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (holding that the FDA must allow dietary supplement labels to make qualified health claims, which are claims for which there is emerging evidence, albeit evidence not yet sufficient to meet the "significant scientific agreement standard").
104. 152 Cong. Rec. H9245 (daily ed. December 12, 2006) (statement by Rep. Pallone); H. A. Brown, "Comments: The Need for Regulation Mandating the Labeling of Inactive Ingredients in Pharmaceuticals," The American University Administrative Law Journal 8 (1994): 303-305; Editorial, "Buyer Beware: Makers of Dietary Supplements Should Have to Prove Safety," Salt Lake Tribune, August 29, 2006. See also New York State Task Force on Life and the Law, "Dietary Supplements: Balancing Consumer Choice and Safety," 2005, at 52-68, available at http://www.health.state.ny.us/regulations/ task_force/docs/dietary_supplement_safety.pdf last visited February 7, 2007).
105. In 1994, approximately 4,000 dietary supplements were available in the United States. In 2006, an estimated 29,000 dietary supplements, generating over $18 billion in sales, were routinely available at over-the-counter in grocery stories, pharmacies and health food stores. See A. S. Lewis Overview of Dietary Supplements Gradient Trends, Winter 2006, at 1. The dietary supplement industry's growth was one of the motivations for Congressional action. 152 Cong. Rec. H9245 (daily ed. Dec. 8, 2006 statement by Rep. Pallone).
106. NIH, Office of Dietary Supplements, Frequently Asked Questions, available at http://ods.od.nih.gov/Health_Information/ODS_Frequently_Asked_Questions. aspx#Information last visited February 7, 2007); see Miller and Longtin, supra note 3. See also FTC, Bureau of Consumer Protection, Dietary Supplements: An Advertising Guide for Industry, April 2001, at 3,9, available at http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.pdf last visited February 7, 2007).
107. DSHEA, 21 U.S.C.A. §§ 321, 342 (2006).
108. Testimony of Michael, F. Mangano, Principal Inspector General for the Department of Health and Human Services, before the Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia, July 31, 2002, at 1.
109. Even the best adverse event reporting systems only detect a small proportion of the events that actually occur. Id., at 3.
110. Consumer medical records, product ingredients and manufacturer identity were all cited as "much needed information" foradequate follow-up, but which the FDA was frequently unable to obtain. Id., at 4-6.
111. The FDA has noted that the dearth of clinical studies and information on consumer use has made it difficult to assess or confirm that a public health problem exists. Id., at 7-9.
112. Senate Report No. 109-324, September 5, 2006, at 4. See also Nixon Peabody L.L.P. Senate Report No. 109-324, September 5, 2006, at 4. See also Nixon Peabody L.L.P." January 19, 2007, available at http://www. nixonpeabody.com/pub-lications_detail3.asp?ID=1669 last visited January 26, 2007).
113. U.S. Department of Health and Human Services (DHHS) Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk," 21 Code of Federal Regulations Part 119, available at 69 Federal Register 6788-01, 6813.
114. U.S. FDA FDA News: Statement from FDA Deputy Commissioner Crawford Regarding Metabolife August 15, 2002, available at http://www.fda.gov/bbs/ topics/NEWS/2002/NEW00828.html last visited February 7, 2007).
115. U.S. General Accounting Office (GAO) Dietary Supplements for Weight Loss: Limited Federal Oversight Has Focused More on Marketing Than on Safety," GAO-02-985T, July 31, 2002; U.S. GAO, "Dietary Supplements: Review of Health-Related Call Records for Users of Metabolife 356 GAO-03-494, March 31, 2003). See also CBS News, "Dangerous Enough to Ban?" February 10, 2003, available at http://www.cbsnews.com/stories/2003/02/10/eveningnews/print- able540085.shtml last visited February 7, 2007).
116. Id.
117. See Committee on Health, Education, Labor and Pensions, Senate Report on Dietary Supplement and Nonprescription Drug Consumer Protection Act, No. 109-324, September 5, 2006, at 4.
118. 152 Cong. Rec. S6286 daily ed. July 21, 2006).
119. Id.
120. Id.
121. DSNDCPA §§ 760(e), 761(e), 21 U.S.C.A. § 371 (2006).
122. See Committee on Health, Education, Labor and Pensions, supra note 17, at 5.
123. Only distributors whose names appear on the label of a dietary supplement or nonprescription drug are subject to this reporting requirement. See DSNDCPA §§ 760(b)(1), 761(b)(1), 21 U.S.C.A. § 371 (2006).
124. Borrowing from the definition used by the FDA's Safety Information and Adverse Event Reporting Program ("Med-Watch"), a serious adverse event is de-fined as an adverse event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect. Id., at § 706(a)(3).
125. Reporting serious adverse events was previously voluntary. Id.
126. DSNDCPA §§ 760, 761, 21 U.S.C.A. § 371 (2006).
127. Id. at §§ 760(e), 761(e) (codified in 21 U.S.C.A. § 371). Authorized employees of the Department of Health and Human Services may access these records. Id.
128. Id. at §§ 760(d), 761(d) (codified in 21 U.S.C.A. § 352) (2006).
129. Id.
130. These releases are subject to the protections of the Privacy Act of 1974 and the Freedom of Information Act. Id. at §§ 760(f), 761(f) (codified in 21 U.S.C.A. § 371) (2006).
131. Id., at § 4 (codified in 21 U.S.C.A. § 331) (2006).
132. Id., at §§ 760(h), 761(h) (codified in 21 U.S.C.A. § 371) (2006).
133. See, e.g., New York State Task Force on Law and the Law, supra note 4, at 19-20.
134. Institute of Medicine The Future of Drug Safety: Promoting and Protecting the Health of the Public 2006, at 85-90. See also Mangano, supra note 8, at 3; Office of Inspector General (OIG), "U.S. Department of Health and Human Services, Adverse Event Reporting for Dietary Supplements," OEI-01-00-00180, April 2001, at ii-vi, 5.
135. OIG, supra note 34, at 10-11.
136. Id.
137. See Mangano, supra note 8, at 4-6.
138. Id.; see OIG, supra note 34, at 20-22.
139. OIG, supra note 34, at 11-12.
140. Id., at 15-18.
141. See Miller and Longtin, supra note 3.
142. See U.S. FDA, Overview of Dietary Supplements, available at http://vm.cfsan.fda.gov/∼dms/ds-oview.html last visited January 26, 2007). Moreover, the lack of standardized testing methods for dietary supplements and nonprescription drugs makes it difficult even for conscientious manufacturers to assure the safety of their product or even to produce reliable ingredient data. A. D. Wait Limitations of Test Methods Gradient Trends (Winter 2006 at 4.
143. The promulgation and subsequent withdrawal of proposed rules for Ephedra-containing supplements highlights the difficulty of regulatory action without sufficient clinical data. See U.S. GAO, "Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids," GAO/HEHS/GGD-99-90, July 1999.
144. See Mangano, supra note 8, at 4-6; see also OIG, supra note 34, at 9.
145. While "responsible parties" maynow comply because of the potential penalties, such deception is hardly unprecedented. In 1999, Metabolife told the FDA that it had "never been made aware of any adverse health events by consumers of its products" or"received a notice from a consumer that any serious adverse health event had occurred because of ingestion of Metabolife 356." Yet a federal investigation revealed that Metabolife was actually holding 16,500 adverse event reports, including at least 2,000 that could be classified as serious. 152 Cong. Rec. S11381, December 6, 2006 (Sen. Durbin).
146. 152 Cong. Rec.S6287, daily ed. June 21, 2006) (remarks by Sen. Hatch) (discussing attempts to appropriate more funds for the FDA to assist enforcement efforts).
147. See DSHEA § 4, 21 U.S.C. §342(f) (2000).
148. Mangano, supra note 8, at 7.
149. See OIG, supra note 34, at 17-18.
150. Id.