The FDA: Is it Protecting the Public with One Hand Tied behind its Back?

Pub. L. No. 384, 34 Stat. 768 (1906). This law required only that drugs meet official standards of strength and purity. The Evolution of U.S. Drug Law, From Test Tube to Patient: New Drug Development in the United States, FDA publication, 28, 28 (1990).

See Young J.H. , The Toadstool Millionaires: A Social History of Patent Medicines in America Before Federal Regulation 205–244 (1972).

See Upton Sinclair , The Jungle (1906).

Pub. L. No. 717, 52 Stat. 1040 (1938) (codified as amended in scattered sections of 21 U.S.C.) (requiring a manufacturer to provide evidence of the safety of a drug before that drug could be marketed).

107 people died as a result of having ingested the“Elixir Sulfanilamide,”which consisted of the antibiotic sulfanilamide dissolved in a poisonous solvent. The Evolution of U.S. Drug Law, supra note 1, at 28.

The drug thalidomide was linked to the birth of thousands of deformed babies in Europe, but the United States was spared a similar tragedy because the FDA had not approved the use of the drug. Id. The Drug Amendments of 1962, Pub. L. No. 87–781, 76 Stat. 780 (1962) (codified as amended at 21 U.S.C. § 351) (requiring a manufacturer to prove that a drug was both safe and effective before it could be marketed).

See Boyce Rensberger,“Breast Implant Study Findings Misrepresented; One of Four Beagles Died in 1973 Company Test,”Washington Post, Jan. 16, 1992, at A1.

Id.

See Hilts Philip J. ,“FDA Restricts Use of Implants Pending Studies,”N.Y. Times, April 17, 1992, at A1.

Id.

Id. The use of the implants for reconstruction will be allowed following mastectomy or accident and in cases of congenital deformity. However, implant use for cosmetic purposes will be limited to those women who take part in clinical studies. See id.

See Hilts Philip J. , As It Quits Implant Business, Maker Says Product is Safe, N.Y. Times, March 20, 1992, at A12.

See Kennedy John H. , Secrecy Orders Put New Burdens on Legal System, The Boston Globe, Feb. 5, 1992, at 53.

see Seligman Jean , Another Blow to Implants, Newsweek, Jan. 6, 1992, at 45.

Id.

see Kolata Gina , Maker of Sleeping Pill Hid Data on Side Effects, Researchers Say, N.Y. Times, Jan. 20, 1992, at A1 (describing evidence that Upjohn dropped subjects who had adverse reactions to the Halcion from its clinical trials of the drug).

Id.

See Grundberg v. The Upjohn Co., 813 P.2d 89 (Utah 1991) (interpreting an aspect of Utah tort law). The case was settled on August 5, 1991. See Grundberg v. The Upjohn Co., 1991 U.S. Dist. LEXIS 1499 1 (D. Utah Oct. 4, 1991).

See Kolata, supra note 16, at A1 (quoting Dr. Ian Oswald, the longtime head of the department of psychiatry of the University of Edinburgh, now retired, who has studied Halcion research data extensively).

Id.

See Upjohn Sues for Libel in U. K. Over Reports Critical of its Halcion,”Wall Street Journal, January 27, 1992, at C3.

see Kolata Giana , Records Indicate Company Ignored Warning on Drug, N.Y. Times, July 4, 1991, at A1.

Id.

Id. Internal company documents obtained by the consumer group Public Citizen provided evidence that Hoffmann-La Roche knew in 1984 that British doctors had problems with Versed. See Liz Hunt, Drug Maker Accused of Withholding Data From FDA, Washington Post, Aug. 1, 1991, at A21.

Id.

see Gorman Christine , Special Report: Drug Safety; Can Drug Firms be Trusted? Time, Feb. 10, 1992, at 42.

See 21 U.S.C. § 355(b)(1)(A) (1988).

137 Cong. Rec. S1870 7 (daily ed. Nov. 27, 1991).

H.R. 3642, 102d Cong., 1st Sess. (1991) (proposed by Representative Waxman and Representative Dingell); S. 2135, 102d Cong., 1st Sess. (1991) (introduced by Senator Kennedy).

See H.R. 3642, sec. 5, § 307(c)(1) (to be codified as amended at 21 U.S.C. § 337); S. 2135, sec. 5, § 307(c)(1) (to be codified as amended at 21 U.S.C. § 337).

See 15 U.S.C. § 2076(b) (1988).

See 15 U.S.C. § 57b-1 (1988).

5 U.S.C. § 552 (1988).

Id. at § 552(b)(4) (1988). See also Giza v. Secretary of Health and Human Services, 628 F.2d 748, 752 (1st Cir. 1980) (upholding the power of the FDA Commissioner to prohibit the testimony of an FDA employee in private civil litigation under 5 U.S.C. § 301; 21 C.F.R. § 20.1).

See H.R. 3642, sec. 5, § 307(e)(1) (to be codified as amended at 21 U.S.C. § 337); S. 2135, sec. 5, § 307(e)(1) (to be codified as amended at 21 U.S.C. § 337).

See 15 U.S.C. §§ 2061 & 2064 (1988).

See 15 U.S.C. § 1414 (1988).

The FDA was granted recall authority for medical devices by the Safe Medical Devices Act of 1990, Pub. L. No. 101–629, 104 Stat. 4511, 4520–21 (1990) (codified as amended at 21 U.S.C. § 360h(e)).

FDA is part of the Department of Health and Human Services, and NHTSA is part of the Department of Transportation.

See H.R. 3642, sec. 3(a), § 308(a)(1) (to be codified as amended at 21 U.S.C. § 331 et seq.); S. 2135, sec. 3(a), § 308(a) (to be codified as amended at 21 U.S.C. § 331 et seq.).

See supra note 38.

See, e.g., Hilts Philip J. , U.S. Cracks Down on Health Devices Made Before 1976, N.Y. Times, Feb. 24, 1992, at A1. Congressional investigations showed that over 400 people died when their heart valves fractured. A recent Dutch study finding that the failure rate of the faulty valve is five times higher than previously thought has prompted the FDA to recommend surgical removal of the valve in some cases. See Barry Meier, Flawed Heart Valve is presenting Patients With Harrowing Choice, N.Y. Times, March 14, 1992, at 1.

Kolata Gina , Manufacturer of Faulty Heart Valve Barred Data on Dangers, F.D.A. Says, N.Y. Times, March 21, 1992, at 50, citing internal FDA report from 1990.

See Sonni Efron, Heart Valve Maker Offers to Settle Lawsuits, L.A. Times, Jan. 25, 1992 at A1.

424 U.S. 319 (1976) (detailing a three factor balancing test of procedural due process which weighed: (1) the private interest that will be affected by the official action; (2) the risk of an erroneous deprivation of that interest through the procedure used, and probable value, if any, of additional procedural safeguards; and (3) the government's interest, including the fiscal and administrative burdens that the additional or substitute procedures would entail).

See H.R. 3642, sec. 3, § 308(a)(1) (to be codified as amended at 21 U.S.C. § 331 et seq.).

See S. 2135, sec. 3(a), § 308(a) (to be codified as amended at 21 U.S.C. § 331 et seq.).

See H.R. 3642, sec. 3(a), § 308(a)(1) (to be codified as amended at 21 U.S.C. § 331 et seq.); S. 2135, sec. 3(a), § 308(a) (to be codified as amended at 21 U.S.C. § 331 et seq.).

See FDA Held Too Weak in Report, Chemical Marketing Reporter, Oct. 14, 1991, at 5.

See Pub. L. No. 101–629, 104 Stat. 4511, 4520–21 (1990) (codified as amended at 21 U.S.C. § 333(f)) (West Supp. 1991) (stating that fines are not to exceed $15,000 for each violation and are not in aggregate to be greater than $1 million for a single proceeding).

Pub. L. No. 97–35, 95 Stat. 598 (1981) (codified as amended at 21 U.S.C.A. § 360pp(b)(1)) (West Supp. 1991) (transferred from 42 U.S.C. § 263(k)) (limiting liability under this statute to $1000 per separate violation and $300,000 for a related series of violations).

See H.R. 3642, sec.6, § 309(a) (to be codified as amended at 21 U.S.C. § 331 et seq.) (limiting civil penalties to $250,000 for individuals and $1 million for corporations for each violation of the F, D, and C Act; and imposing the same penalties for misrepresenting or withholding material information from the FDA); S.2135, sec.6, § 309(a) (to be codified as amended by 21 U.S.C. §331 et seq.) (setting identical limits for interference with an FDA investigation, but restricting civil penalties for substantive violations of the F, D, and C Act to $25,000 for individuals and $100,000 for corporations).

See H.R. 3642, sec. 6, § 309(e) (to be codified as amended at 21 U.S.C. § 331 et seq.); S. 2135, sec. 6, § 309(d) (to be codified as amended at 21 U.S.C. § 331 et seq.).

Cohn Jeffrey P. , The Beginnings: Laboratory and Animal Studies, From Test Tube to Patient: New Drug Development in the United States, FDA publication, 6, 7 (1990).

See, e.g., Nutrition Labeling and Education Act of 1990, Pub. L. No. 101–535, 104 Stat. 2353 (1990) (requiring the FDA to promulgate more stringent food labeling standards).