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Recent Developments in Health Law: States Lead the Way on Health Insurance Reform

Published online by Cambridge University Press:  01 January 2021

Eric Benson
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JLME Column
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Journal of Law, Medicine & Ethics , Volume 35 , Issue 2 , Summer 2007 , pp. 329 - 339
Copyright
Copyright © American Society of Law, Medicine and Ethics 2007

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Footnotes

The American Journal of Law & Medicine has been tracking and contributing to the development of health law since its inception at Boston University School of Law in 1975. The Journal publishes articles authored by professors, attorneys, physicians, and other health care professionals on subjects ranging from health law and policy to the legal, ethical, and economic aspects of medical practice, research, and education.

The Harvard Law & Health Care Society is a student-operated health law organization at Harvard University Law School. In addition to contributing to this column, the Harvard Law & Health Care Society also hosts speakers from private practice and academia, presents career panels, and promotes interdisciplinary dialogue with other Harvard University graduate schools.

References

References

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17. 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.Google Scholar
18. 152 Cong. Rec. S6286 (daily ed. July 21, 2006).Google Scholar
19. Id.Google Scholar
20. Id.Google Scholar
21. DSNDCPA §§ 760(e), 761(e), 21 U.S.C.A. § 371 (2006).Google Scholar
22. See Committee on Health, Education, Labor and Pensions, supra note 17, at 5.Google Scholar
23. 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).Google Scholar
24. Borrowing from the definition used by the FDA’s Safety Information and Adverse Event Reporting Program (“Med- Watch”), a serious adverse event is defined 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).Google Scholar
25. Reporting serious adverse events was previously voluntary. Id.Google Scholar
26. DSNDCPA §§ 760, 761, 21 U.S.C.A. § 371 (2006).Google Scholar
27. 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.Google Scholar
28. Id. at §§ 760(d), 761(d) (codified in 21 U.S.C.A. § 352) (2006).Google Scholar
29. Id.Google Scholar
30. 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).Google Scholar
31. Id., at § 4 (codified in 21 U.S.C.A. § 331) (2006).CrossRefGoogle Scholar
32. Id., at §§ 760(h), 761(h) (codified in 21 U.S.C.A. § 371) (2006).Google Scholar
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36. Id.Google Scholar
37. See Mangano, supra note 8, at 4-6.Google Scholar
38. Id.; see OIG, supra note 34, at 20-22.Google Scholar
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40. Id., at 15-18.Google Scholar
41. See Miller and Longtin, supra note 3.Google Scholar
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43. The promulgation and subsequent withdrawal of proposed rules for Ephedracontaining 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.Google Scholar
44. See Mangano, supra note 8, at 4-6; see also OIG, supra note 34, at 9.Google Scholar
45. While “responsible parties” may now 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).Google Scholar
46. 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).Google Scholar
47. See DSHEA § 4, 21 U.S.C. §342(f ) (2000).CrossRefGoogle Scholar
48. Mangano, supra note 8, at 7.Google Scholar
49. See OIG, supra note 34, at 17-18.Google Scholar
50. Id.Google Scholar