Recent Developments in Law and Policy
The FDA: Is It Protecting the Public with One Hand Tied Behind Its Back? Introduction The history of the enforcement power and jurisdiction of the Food and Drug Administration (FDA) has been marked by expansions of the agency’s power in response to scandals or tragedies. The nation’s first drug law, the Food and Drugs Act of 1906,’ was enacted as a result of the questionable advertising claims of patent medicine companiesz and the public reaction to a novel that portrayed the meat packing industry as filthy.3 Congress passed the Federal Food, Drug, and Cosmetic Act of 19384 following the “Elixir Sulfanilamide” disasters and invigorated the law in 1962 in response to Europe’s thalidomide catastrophe.6 A number of recent controversies have led many to call for strengthening the enforcement powers of the FDA.
Recent controversies A maker of silicon gel breast implants, Dow Corning Corporation, has been suspected of misrepresenting data from a research study on the safety of the implants. Breast implant patients with complications and members of the press accuse the company of failing to report adverse results in published ac-
counts of its safety tests of implants.7 It allegedly did not disclose that one of the four dogs in which breast implants were tested died and another developed a tumor next to the implant.* Dow Corning minimizes the importance of these omissions, claiming that the study in question has no bearing on the overall safety of implants and that the journal in which the study was published is not widely read by plastic surgeons.9 The company also defends its actions by asserting that standards of scientific publishing were less stringent at the time this paper was released.‘O The FDA has recently restricted the use of silicon gel breast implants because of a lack of conclusive evidence demonstrating their safety.” Since then, Dow Corning has ceased manufacturing silicon gel breast implants, saying that the product has lost its profitability.I2 The disclosure of evidence of misreporting was not the result of an FDA investigation. It occurred after a reporter, while covering a trial in which a breast implant patient was suing Dow Corning for fraud, copied down exhibits of internal company memos.’? The jury in this trial found that Dow Corning had fraudulently concealed data concerning the adverse 25 3
effects of breast implants, and the jury awarded $7.3 million to the plaintiff.TA Although evidence concerning implant safety had been presented in other product liability suits, the information remained secret from the public because of a court-issued protective order which prohibited use of documents outside the particular trial.I5 There is also evidence that the Upjohn Company misreported to the FDA the research it performed on the safety of its sleeping pill Halcion. Drug and psychiatric experts who have reviewed company records charge that Upjohn, for over twenty years,concealed the adverse reactions and side effects seen in test subjects taking the drugT6 These critics claim that there is evidence that Halcion causes paranoia, depression, and hall~cinations.~7 This evidence was only uncovered during the discovery phase of a product liability lawsuit filed against Upjohn, in which a plaintiff charged that a Halcion-produced psychosis caused her to fatally shoot her mother.18 In response to this evidence, as well as the characterization of Upjohn’s actions by a leading Scottish psychiatrist as “ ... one long the British government removed Halcion from the U.K. market. While acknowledging that there are some recording errors in the
Volume 20: 3 , Fall 1992 company’s data, Upjohn vigorously denies the allegations of fraud, claiming that the clerical mistakes do not affect the overall safety of Halcion.zo In addition, the company is suing its accusers for libeLzT Last year, there were claims that Hoffmann-La Roche withheld information from the FDA concerning the safety of its sedative Versed, an anesthetic agent that has been allegedly linked to 46 deaths.zz Documents leaked to the press seemed to provide evidence that Hoffmann-La Roche ignored the safety concerns of company officials that Versed was being supplied in too concentrated a f0rrn.~3 The FDA was not informed of deaths that had occurred in Europe prior to the U.S. approval of Versed, nor was it told of the fact that Hoffmann-La Roche was required to lower the concentration and dose of Versed in Britain24 Hoffmann-La Roche insists that the safety concerns of its employees in the documents are being taken out of context and are part of the normal give-and-take of scientific research. The company also points to the fact that Versed passed all the tests required by the FDA.z’ While these are only three cases of alleged fraud, and in each the manufacturer has denied wrong-doing, misreporting of drug research data may be more widespread because of the configuration of the drug approval system. Critics have said the FDA is overly dependent on industry-generated research.L6 Instead of doing its own independent testing of a new drug application, the FDA relies on the manufacturer to perform the necessary studies of safety and efficacy“’ and to report the results honestly. For this dependent arrangement to function properly, the FDA must be able to police its drug approval process adequately and identify those attempting to abuse the system.
Expanded FDA authority The recent controversies have led
some to call for granting the FDA enhanced enforcement powers to enable the agency to better protect the public health. Senator Edward Kennedy has stated: The stark reality is that the FDA simply does not have the necessary means to enforce the law. The enforcement provisions of the Food, Drug, and Cosmetic Act are more than fifty years old ... and have been rendered obsolete by the development of products unimagined half a century ago.ZR Recently proposed amendmentsl9 to the Food, Drug, and Cosmetic Act would give the FDA authority to issue subpoenas, recall defective products, and assess civil monetary penalties. Slightly different versions of this legislation are currently under consideration in both the Senate and the House of Representatives.
Subpoena power At the present time, the FDA lacks subpoena power. The agency cannot compel either the testimony of a witness or the production of documents relating to a drug that is suspected of being unsafe. Both the House and Senate bills would grant the FDA such subpoena power.30 Granting this power would give the FDA authority comparable to that of many other administrative agencies that are charged with protecting public health and safety. For example, the Consumer Product Safety Commission3’ and the Federal Trade Commissi0n3~ are both empowered with subpoena authority. Although these are both independent agencies and the FDA is part of a cabinet department, all three agencies are responsible for matters of public health and safety. In the cases of breast implants, Halcion, and Versed, there are allegations that relevant evidence on product safety was withheld from the FDA. It was only other circumstances, such 254
as litigation, that made the information available. The FDA may have been handicapped by the lack of subpoena power. If the agency were to possess such power, it might be better able to discover relevant information about the safety and efficacy of the products it regulates. Often, plaintiff‘s lawyers in product liability cases are among the first to gain knowledge of relevant information about product safety. However, because of protective orders issued by the courts that bar use of this information outside the specific litigation, this knowledge is kept secret. Manufacturers defend protective orders. They cite the need to safeguard trade secrets and the undesirability of relying on the judgment of a single attorney to determine what information should be made public. Some fear that giving the FDA subpoena power would make manufacturers’ trade secrets accessible to the public under the Freedom of Information Act (FOIA).33 However, trade secrets are exempted from FOIA disclosure.34 In addition, the proposed bills specificallyexclude trade secrets35
Product recall authority The FDA also lacks the product recall authority that other federal agencies possess. Unlike the Consumer Product Safety Commission3hand the National Highway Traffic Safety Administration (NHTSA),j’ the FDA is unable to recall independently products, except for medical devices,jUthat it believes endanger the public. Analogy of the FDA to NHTSA is especially appropriate because both agencies have comparable status in agency hierarchy.’y Without recall authority, the FDA must negotiate with a manufacturer to remove a product from the market. Both proposed bills provide the FDA with product recall authority.40 The case of the Bjork-Shiley prosthetic heart valve demonstrates some of the difficulties that result from the FDA’s lack of product recall power.
Law, Medicine & Health Care Although the FDA was granted recall authority for medical devices by the Safe Medical Devices Act of 1990:’ the agency did not have such authority when this heart valve was on the market. Critics charge that the inability of the FDA to recall the Bjork-Shiley heart valve led to numerous deaths that could have been avoided.4‘ An FDA report issued in 1990 stated that the agency had “identified information that supports the belief that Shiley has engaged in a continuing scheme to interrupt, deflect, and misdirect the FDA’s regulation of the Shiley Convexo-Concave heart valve.”43 The company denies wrongdoing. Despite valve fractures occurring as early as one year after FDA approval of the product in 1979, and voluntary manufacturer recalls in 1980, 1982, and 1983, the defective valve remained on the market until the manufacturer permanently removed it in 1985.44 The valves might have been taken off the market sooner if the FDA had possessed recall authority and did not have to rely on the manufacturer to remove its own product from the market. One argument against granting product recall authority to the FDA is that the agency’s right to remove a product without appropriate procedural safeguards would violate constitutional due process rights. However, if the balancing test for due process enunciated by the Supreme Court in Mathews v. Eldridge45 is applied, the manufacturers’ due process rights would not be violated. The test weighs private interest, government interest, and the risk of erroneous action, to determine if and when an official hearing is required. In Mathews, the Court, after considering the interests at stake, held that a hearing after the termination of social security disability benefits was constitutional. The Mathews test should apply to an FDA product recall action; thus it seems probable that a court would find that the government’s interest in protecting its citizens from dangerous
products clearly outweighs the individual corporation’s property interests in its product or market share of that product. A pre- recall hearing, which affords more due process protection than a post-recall hearing, would probably pass constitutional muster. It is also very possible that a postrecall hearing would be upheld. The House bill calls for a prerecall hearing,+&while the Senate version requires a hearing within ten days after a recall order has been issued.47 In addition, a manufacturer that believes it is a victim of an unjust recall may request judicial review of the FDA’s action. it has also been argued that product recall power is too broad and overreaching. Although under the proposed legislation this power may be exercised only when “there is a reasonable probability that the food, drug, or cosmetic will cause serious, adverse health consequences or death...,”48 industry is still concerned that the FDA will indiscriminately recall products.49
Civil monetary penalties Another proposed enhancement of FDA authority is providing the agency with the power to assess civil monetary penalties against violators of the Food, Drug, and Cosmetic Act. Presently, the FDA can impose civil fines for violations of the Safe Medical Devices Actso and the Consumer-Patient Radiation Health and Safety Act of 1981.5’ The proposed legislation would extend the FDA’s ability to fine violators of the Food, Drug, and Cosmetic Act because the agency would be able to impose civil fines on its own authority, without the intervention of the courts.5z Expanding this civil fining authority to all areas of FDA jurisdiction could be beneficial to FDA-regulated industries. A wider array of available sanctions would be fairer to those manufacturers found to have violated the law because the FDA would have 2s 5
an alternative to seeking stiff criminal penalties and thus would be able to achieve a tighter fit between violation and punishment. As with other agency enforcement actions, civil fines would be subject to judicial review.53
Conclusion The FDA regulates products that account for 25 percent of the U.S. gross national product and oversees the more than 2,400 drugs on the market for which I .6 billion prescriptions are written annually.54 The agency must also deal with the increased burden of the AIDS epidemic, the revolution in biotechnology, and the rapid technological advances of medical devices. Since 1979, more than 20 laws have been enacted that increase the responsibilities of the FDA.‘s Opponents suggest that expanding the FDA’s powers would make the FDA too powerful for an administrative agency. They fear that a strengthened FDA will unduly burden industry and hamper its competitiveness.However, when the arguments both favoring and opposing enhanced FDA authority are weighed, the proposed powers strike a rational balance between public health and the economic well-being of FDA-regulated industry. Roger S. Shedlin
References I. Pub. L. No. 384, 34 Stat. 768 (1906). This law required only that drugs
meet official standards ot strength and purity. The Euolution of U.S. Drug Law, FROMTESTTUBE TO PATIFN.T: NEWDRUG DEVELOPMENT IN THE UNITFD ST-ATES, FDA publication, 28, 28 ( ~ y y o ) . 2. See J.H. Young, T H F ‘T’OAIXTOOL MILLIONAIRES: A Socr~iHISTORY OF PATENT MEDICINES I N AMERICABEFORI: FEDERAL REGU1.AnON
205-244 ( 1 9 7 2 ) .
3 . See Upton Sinclair, THEJUNGLE ( 1 906).
4. PUB.L. No. 717, 5 2 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 mar-
keted).
Volume 20: 3 , Fall 1992 5 . 107 people died as a result of having ingested the “Elixir Sulfanilamide,” which consisted of the antibiotic sulfanilamide dissolved in a poisonous solvent. THEEVOLUTION OF U.S. DRUGLAW,supra note I , at 28. 6. 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. 3 5 I ) (requiring a manufacturer to prove that a drug was both safe and effective before it could be marketed). 7. See Boyce Rensberger, “Breast Implant Study Findings Misrepresented; One of Four Beagles Died in 1973 Company Test,” Washington Post, Jan. 16, 1992, at AI. 8. Id. 9. See Philip J. Hilts, “FDA Restricts Use of Implants Pending Studies,” N.Y. Times, April 17, 1992, at AI. 10. Id. 11. 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. 12.See Philip J. Hilts, As I t Quits Implant Business, Maker Says Product is Safe, N.Y. TIMES, March 20,1992, at A n . 1 3 . See John H. Kennedy, Secrecy Orders Put New Burdens on Legal System, THEBOSTONGLOBE, Feb. 5 , 1992, at 53.
14. See Jean Seligman et al., Another Blow to Implants, NEWSWEEK, Jan. 6, 1992, at 4s. IS. Id. 16. See Gina Kolata, Maker ofsleeping Pill Hid Data on Side Effects, Researchers Say, N.Y. TIMES, Jan. 20,19qz, at AI (describing evidence that Upjohn dropped subjects who had adverse reactions to the Halcion from its clinical trials of the drug). 17. Id. 18. SeeGrundbergv.TheUpjohn Co., 813 P.zd 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 14991 (D. Utah Oct. 4, 1991). 19. See Kolata, supra note 16, at AI (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).
20.
Id.
21. See
Upjohn Sues for Libel in U.K. Over Reports Critical of its Halcion,” WALLSTREET JOURNAL, January 27, 1992, at C3. 22. See Gina Kolata, Records Indicate Company Ignored Warning on Drug, N.Y. TIMES, July 4, 1991, at AI. 23. Id. 24. Id. Internal company documents obtained by the consumer group Public Citizen provided evidence that HoffmannLa 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. I, 1991, at AZI. 25. Id. 26. See Christine Gorman, Special Report: Drug Safety; Can Drug Firms be Trusted? TIME,Feb. 10, 1992, at 42. 27. See 21 U.S.C. 5 3~5(b)(1)(A) (1988). 28. 137 CONG.REC. S18707 (daily ed. Nov. 27, 1991). 29. H.R. 3642, Iozd Cong., 1st Sess. (1991) (proposed by Representative Waxman and Representative Dingell); S. 2135, Iozd Cong., 1st Sess. (1991) (introduced by Senator Kennedy). 30. SeeH.R. 3642, sec. 5, 307(c)(I ) (to be codified as amended at 21 U.S.C. 5 337); S. 2135, set. 5 , 5 307(c)(r)(to be codified as amended at 21 U.S.C. 5 337). 31. See 1 5 U.S.C. 2076(b) (1988). 32. See 15 U.S.C. 5 57b-I (1988). 33. 5 U.S.C. 5 5 5 2 (1988). 34. Id. at 552(b)(4)(1988). See also Giza v. Secretary of Health and Human Services, 628 F.rd 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. S 301; 21 C.F.R. S 20.1).
35.SeeH.R.3642,sec. 5 , s 307(e)(1) (to be codified as amended at 21 U.S.C. 337); S. 2135, sec. 5, S 307(e)(1) (to be codified as amended at 21 U.S.C. 5 337). 36.See 1 5 U.S.C. SS 2061 & 2064 (1988). 37. See 15 U.S.C. 5 1414 (1988). 38. 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. S 360hie)). 39. FDA is part of the Department of Health and Human Services, and NHTSA is part of the Department of Transportation. 4o.See H.R. 3642, sec. 3(a), S 308(a)(1) (to be codified as amended at 21 U.S.C. S 331 et seq.); S. 2 1 3 5 , sec. 3(a), 5 308(a) (to be codified as amended
at 21 U.S.C. S 331 et seq.). 41. See supra note 38. 42. See, e.g., Philip J. Hilts, U.S. Cracks Down on Health Devices Made Before 1976, N.Y. TIMES, Feb. 24, 1992, at AI. 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 Value is presenting Patients With Harrowing Choice, N.Y. TIMES, March 14, 1992, at I. 43. Gina Kolata, 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. 44. See Sonni Efron, Heart Value Maker Offers to Settle Lawsuits, L.A. TIMES, Jan. 25, 1992 at AI. 45. 424 U.S. 3 19 (1976) (detailing a three factor balancing test of procedural due process which weighed: ( I ) 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). 46. SeeH.R. 3642, sec. 3,s 308(a)(1) (to be codified as amended at 21 U.S.C. 5 3 3 I et seq.). 47.See S. 2135, sec. 3(a), S 308(a) (to be codified as amended at 21 U.S.C. S 33 I et seq.). 48.See H.R. 3642, sec. 3(a), S 308(a)(1) (to be codified as amended at 21 U.S.C. 331 et seq.); S. 2135, sec. 3(a), S 308(a) (to be codified as amended at 21 U.S.C. 331 etseq.). 49. See FDA Held Too Weak in Report, CHEMICAL MARKETING REPORTER, Oct. 14, 1991, at 5. 5o.See Pub. L. No. 101-629, 104 Stat. 4511, 4520-21 (1990) (codified as amended at 21 U.S.C. 5 333(f)) (West Supp. 1991) (stating that fines are not to exceed $I 5,000 for each violation and are not in aggregate to be gr ater than $I million for a single procee ing). 51. Pub. L. No. 97-35, 95 Stat. 598 (1981) (codified as amended at 21 U.S.C.A. S 36opp(b)(1)) (West Supp. 1991) (transferred from 42 U.S.C. S 263(k)) (limiting liability under this statute to $1000 per separate violation and $300,000 for a related series of violations).
2
Law, Medicine 6Health Care
s
gz.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 $zso,ooo for individuals and $ I 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.) (set-
s
ting 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 $IOO,OOO for corporations). 53.See H.R. 3642, sec. 6, 309(e) (to be codified as amended at ZI U.S.C. 331 etseq.); s. 2135, sec. 6 , $ 309(d) (to be codified as amended at 21 U.S.C. 331 etseq.).
s
s
s
54. Jeffrey P. Cohn, The Beginnings: Laboratory and Animal Studies, FROM TESTTUBE TO PATIENT: NEWDRUGDEVELOPMENT IN THE UNITEDSTATES, FDA publication, 6 , 7 (1990). 5 5 . See, e.g., NUTRITION LABELING AND EDUCATION ACI'OF 1990, Pub. I.. NO. LOI535, 104 Stat. 2353 (1990) (requiring the FDA to promulgate more stringent food labeling standards).
The FDA: Is It Protecting the Public with One Hand Tied Behind Its Back? Introduction The history of the enforcement power and jurisdiction of the Food and Drug Administration (FDA) has been marked by expansions of the agency’s power in response to scandals or tragedies. The nation’s first drug law, the Food and Drugs Act of 1906,’ was enacted as a result of the questionable advertising claims of patent medicine companiesz and the public reaction to a novel that portrayed the meat packing industry as filthy.3 Congress passed the Federal Food, Drug, and Cosmetic Act of 19384 following the “Elixir Sulfanilamide” disasters and invigorated the law in 1962 in response to Europe’s thalidomide catastrophe.6 A number of recent controversies have led many to call for strengthening the enforcement powers of the FDA.
Recent controversies A maker of silicon gel breast implants, Dow Corning Corporation, has been suspected of misrepresenting data from a research study on the safety of the implants. Breast implant patients with complications and members of the press accuse the company of failing to report adverse results in published ac-
counts of its safety tests of implants.7 It allegedly did not disclose that one of the four dogs in which breast implants were tested died and another developed a tumor next to the implant.* Dow Corning minimizes the importance of these omissions, claiming that the study in question has no bearing on the overall safety of implants and that the journal in which the study was published is not widely read by plastic surgeons.9 The company also defends its actions by asserting that standards of scientific publishing were less stringent at the time this paper was released.‘O The FDA has recently restricted the use of silicon gel breast implants because of a lack of conclusive evidence demonstrating their safety.” Since then, Dow Corning has ceased manufacturing silicon gel breast implants, saying that the product has lost its profitability.I2 The disclosure of evidence of misreporting was not the result of an FDA investigation. It occurred after a reporter, while covering a trial in which a breast implant patient was suing Dow Corning for fraud, copied down exhibits of internal company memos.’? The jury in this trial found that Dow Corning had fraudulently concealed data concerning the adverse 25 3
effects of breast implants, and the jury awarded $7.3 million to the plaintiff.TA Although evidence concerning implant safety had been presented in other product liability suits, the information remained secret from the public because of a court-issued protective order which prohibited use of documents outside the particular trial.I5 There is also evidence that the Upjohn Company misreported to the FDA the research it performed on the safety of its sleeping pill Halcion. Drug and psychiatric experts who have reviewed company records charge that Upjohn, for over twenty years,concealed the adverse reactions and side effects seen in test subjects taking the drugT6 These critics claim that there is evidence that Halcion causes paranoia, depression, and hall~cinations.~7 This evidence was only uncovered during the discovery phase of a product liability lawsuit filed against Upjohn, in which a plaintiff charged that a Halcion-produced psychosis caused her to fatally shoot her mother.18 In response to this evidence, as well as the characterization of Upjohn’s actions by a leading Scottish psychiatrist as “ ... one long the British government removed Halcion from the U.K. market. While acknowledging that there are some recording errors in the
Volume 20: 3 , Fall 1992 company’s data, Upjohn vigorously denies the allegations of fraud, claiming that the clerical mistakes do not affect the overall safety of Halcion.zo In addition, the company is suing its accusers for libeLzT Last year, there were claims that Hoffmann-La Roche withheld information from the FDA concerning the safety of its sedative Versed, an anesthetic agent that has been allegedly linked to 46 deaths.zz Documents leaked to the press seemed to provide evidence that Hoffmann-La Roche ignored the safety concerns of company officials that Versed was being supplied in too concentrated a f0rrn.~3 The FDA was not informed of deaths that had occurred in Europe prior to the U.S. approval of Versed, nor was it told of the fact that Hoffmann-La Roche was required to lower the concentration and dose of Versed in Britain24 Hoffmann-La Roche insists that the safety concerns of its employees in the documents are being taken out of context and are part of the normal give-and-take of scientific research. The company also points to the fact that Versed passed all the tests required by the FDA.z’ While these are only three cases of alleged fraud, and in each the manufacturer has denied wrong-doing, misreporting of drug research data may be more widespread because of the configuration of the drug approval system. Critics have said the FDA is overly dependent on industry-generated research.L6 Instead of doing its own independent testing of a new drug application, the FDA relies on the manufacturer to perform the necessary studies of safety and efficacy“’ and to report the results honestly. For this dependent arrangement to function properly, the FDA must be able to police its drug approval process adequately and identify those attempting to abuse the system.
Expanded FDA authority The recent controversies have led
some to call for granting the FDA enhanced enforcement powers to enable the agency to better protect the public health. Senator Edward Kennedy has stated: The stark reality is that the FDA simply does not have the necessary means to enforce the law. The enforcement provisions of the Food, Drug, and Cosmetic Act are more than fifty years old ... and have been rendered obsolete by the development of products unimagined half a century ago.ZR Recently proposed amendmentsl9 to the Food, Drug, and Cosmetic Act would give the FDA authority to issue subpoenas, recall defective products, and assess civil monetary penalties. Slightly different versions of this legislation are currently under consideration in both the Senate and the House of Representatives.
Subpoena power At the present time, the FDA lacks subpoena power. The agency cannot compel either the testimony of a witness or the production of documents relating to a drug that is suspected of being unsafe. Both the House and Senate bills would grant the FDA such subpoena power.30 Granting this power would give the FDA authority comparable to that of many other administrative agencies that are charged with protecting public health and safety. For example, the Consumer Product Safety Commission3’ and the Federal Trade Commissi0n3~ are both empowered with subpoena authority. Although these are both independent agencies and the FDA is part of a cabinet department, all three agencies are responsible for matters of public health and safety. In the cases of breast implants, Halcion, and Versed, there are allegations that relevant evidence on product safety was withheld from the FDA. It was only other circumstances, such 254
as litigation, that made the information available. The FDA may have been handicapped by the lack of subpoena power. If the agency were to possess such power, it might be better able to discover relevant information about the safety and efficacy of the products it regulates. Often, plaintiff‘s lawyers in product liability cases are among the first to gain knowledge of relevant information about product safety. However, because of protective orders issued by the courts that bar use of this information outside the specific litigation, this knowledge is kept secret. Manufacturers defend protective orders. They cite the need to safeguard trade secrets and the undesirability of relying on the judgment of a single attorney to determine what information should be made public. Some fear that giving the FDA subpoena power would make manufacturers’ trade secrets accessible to the public under the Freedom of Information Act (FOIA).33 However, trade secrets are exempted from FOIA disclosure.34 In addition, the proposed bills specificallyexclude trade secrets35
Product recall authority The FDA also lacks the product recall authority that other federal agencies possess. Unlike the Consumer Product Safety Commission3hand the National Highway Traffic Safety Administration (NHTSA),j’ the FDA is unable to recall independently products, except for medical devices,jUthat it believes endanger the public. Analogy of the FDA to NHTSA is especially appropriate because both agencies have comparable status in agency hierarchy.’y Without recall authority, the FDA must negotiate with a manufacturer to remove a product from the market. Both proposed bills provide the FDA with product recall authority.40 The case of the Bjork-Shiley prosthetic heart valve demonstrates some of the difficulties that result from the FDA’s lack of product recall power.
Law, Medicine & Health Care Although the FDA was granted recall authority for medical devices by the Safe Medical Devices Act of 1990:’ the agency did not have such authority when this heart valve was on the market. Critics charge that the inability of the FDA to recall the Bjork-Shiley heart valve led to numerous deaths that could have been avoided.4‘ An FDA report issued in 1990 stated that the agency had “identified information that supports the belief that Shiley has engaged in a continuing scheme to interrupt, deflect, and misdirect the FDA’s regulation of the Shiley Convexo-Concave heart valve.”43 The company denies wrongdoing. Despite valve fractures occurring as early as one year after FDA approval of the product in 1979, and voluntary manufacturer recalls in 1980, 1982, and 1983, the defective valve remained on the market until the manufacturer permanently removed it in 1985.44 The valves might have been taken off the market sooner if the FDA had possessed recall authority and did not have to rely on the manufacturer to remove its own product from the market. One argument against granting product recall authority to the FDA is that the agency’s right to remove a product without appropriate procedural safeguards would violate constitutional due process rights. However, if the balancing test for due process enunciated by the Supreme Court in Mathews v. Eldridge45 is applied, the manufacturers’ due process rights would not be violated. The test weighs private interest, government interest, and the risk of erroneous action, to determine if and when an official hearing is required. In Mathews, the Court, after considering the interests at stake, held that a hearing after the termination of social security disability benefits was constitutional. The Mathews test should apply to an FDA product recall action; thus it seems probable that a court would find that the government’s interest in protecting its citizens from dangerous
products clearly outweighs the individual corporation’s property interests in its product or market share of that product. A pre- recall hearing, which affords more due process protection than a post-recall hearing, would probably pass constitutional muster. It is also very possible that a postrecall hearing would be upheld. The House bill calls for a prerecall hearing,+&while the Senate version requires a hearing within ten days after a recall order has been issued.47 In addition, a manufacturer that believes it is a victim of an unjust recall may request judicial review of the FDA’s action. it has also been argued that product recall power is too broad and overreaching. Although under the proposed legislation this power may be exercised only when “there is a reasonable probability that the food, drug, or cosmetic will cause serious, adverse health consequences or death...,”48 industry is still concerned that the FDA will indiscriminately recall products.49
Civil monetary penalties Another proposed enhancement of FDA authority is providing the agency with the power to assess civil monetary penalties against violators of the Food, Drug, and Cosmetic Act. Presently, the FDA can impose civil fines for violations of the Safe Medical Devices Actso and the Consumer-Patient Radiation Health and Safety Act of 1981.5’ The proposed legislation would extend the FDA’s ability to fine violators of the Food, Drug, and Cosmetic Act because the agency would be able to impose civil fines on its own authority, without the intervention of the courts.5z Expanding this civil fining authority to all areas of FDA jurisdiction could be beneficial to FDA-regulated industries. A wider array of available sanctions would be fairer to those manufacturers found to have violated the law because the FDA would have 2s 5
an alternative to seeking stiff criminal penalties and thus would be able to achieve a tighter fit between violation and punishment. As with other agency enforcement actions, civil fines would be subject to judicial review.53
Conclusion The FDA regulates products that account for 25 percent of the U.S. gross national product and oversees the more than 2,400 drugs on the market for which I .6 billion prescriptions are written annually.54 The agency must also deal with the increased burden of the AIDS epidemic, the revolution in biotechnology, and the rapid technological advances of medical devices. Since 1979, more than 20 laws have been enacted that increase the responsibilities of the FDA.‘s Opponents suggest that expanding the FDA’s powers would make the FDA too powerful for an administrative agency. They fear that a strengthened FDA will unduly burden industry and hamper its competitiveness.However, when the arguments both favoring and opposing enhanced FDA authority are weighed, the proposed powers strike a rational balance between public health and the economic well-being of FDA-regulated industry. Roger S. Shedlin
References I. Pub. L. No. 384, 34 Stat. 768 (1906). This law required only that drugs
meet official standards ot strength and purity. The Euolution of U.S. Drug Law, FROMTESTTUBE TO PATIFN.T: NEWDRUG DEVELOPMENT IN THE UNITFD ST-ATES, FDA publication, 28, 28 ( ~ y y o ) . 2. See J.H. Young, T H F ‘T’OAIXTOOL MILLIONAIRES: A Socr~iHISTORY OF PATENT MEDICINES I N AMERICABEFORI: FEDERAL REGU1.AnON
205-244 ( 1 9 7 2 ) .
3 . See Upton Sinclair, THEJUNGLE ( 1 906).
4. PUB.L. No. 717, 5 2 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 mar-
keted).
Volume 20: 3 , Fall 1992 5 . 107 people died as a result of having ingested the “Elixir Sulfanilamide,” which consisted of the antibiotic sulfanilamide dissolved in a poisonous solvent. THEEVOLUTION OF U.S. DRUGLAW,supra note I , at 28. 6. 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. 3 5 I ) (requiring a manufacturer to prove that a drug was both safe and effective before it could be marketed). 7. See Boyce Rensberger, “Breast Implant Study Findings Misrepresented; One of Four Beagles Died in 1973 Company Test,” Washington Post, Jan. 16, 1992, at AI. 8. Id. 9. See Philip J. Hilts, “FDA Restricts Use of Implants Pending Studies,” N.Y. Times, April 17, 1992, at AI. 10. Id. 11. 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. 12.See Philip J. Hilts, As I t Quits Implant Business, Maker Says Product is Safe, N.Y. TIMES, March 20,1992, at A n . 1 3 . See John H. Kennedy, Secrecy Orders Put New Burdens on Legal System, THEBOSTONGLOBE, Feb. 5 , 1992, at 53.
14. See Jean Seligman et al., Another Blow to Implants, NEWSWEEK, Jan. 6, 1992, at 4s. IS. Id. 16. See Gina Kolata, Maker ofsleeping Pill Hid Data on Side Effects, Researchers Say, N.Y. TIMES, Jan. 20,19qz, at AI (describing evidence that Upjohn dropped subjects who had adverse reactions to the Halcion from its clinical trials of the drug). 17. Id. 18. SeeGrundbergv.TheUpjohn Co., 813 P.zd 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 14991 (D. Utah Oct. 4, 1991). 19. See Kolata, supra note 16, at AI (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).
20.
Id.
21. See
Upjohn Sues for Libel in U.K. Over Reports Critical of its Halcion,” WALLSTREET JOURNAL, January 27, 1992, at C3. 22. See Gina Kolata, Records Indicate Company Ignored Warning on Drug, N.Y. TIMES, July 4, 1991, at AI. 23. Id. 24. Id. Internal company documents obtained by the consumer group Public Citizen provided evidence that HoffmannLa 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. I, 1991, at AZI. 25. Id. 26. See Christine Gorman, Special Report: Drug Safety; Can Drug Firms be Trusted? TIME,Feb. 10, 1992, at 42. 27. See 21 U.S.C. 5 3~5(b)(1)(A) (1988). 28. 137 CONG.REC. S18707 (daily ed. Nov. 27, 1991). 29. H.R. 3642, Iozd Cong., 1st Sess. (1991) (proposed by Representative Waxman and Representative Dingell); S. 2135, Iozd Cong., 1st Sess. (1991) (introduced by Senator Kennedy). 30. SeeH.R. 3642, sec. 5, 307(c)(I ) (to be codified as amended at 21 U.S.C. 5 337); S. 2135, set. 5 , 5 307(c)(r)(to be codified as amended at 21 U.S.C. 5 337). 31. See 1 5 U.S.C. 2076(b) (1988). 32. See 15 U.S.C. 5 57b-I (1988). 33. 5 U.S.C. 5 5 5 2 (1988). 34. Id. at 552(b)(4)(1988). See also Giza v. Secretary of Health and Human Services, 628 F.rd 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. S 301; 21 C.F.R. S 20.1).
35.SeeH.R.3642,sec. 5 , s 307(e)(1) (to be codified as amended at 21 U.S.C. 337); S. 2135, sec. 5, S 307(e)(1) (to be codified as amended at 21 U.S.C. 5 337). 36.See 1 5 U.S.C. SS 2061 & 2064 (1988). 37. See 15 U.S.C. 5 1414 (1988). 38. 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. S 360hie)). 39. FDA is part of the Department of Health and Human Services, and NHTSA is part of the Department of Transportation. 4o.See H.R. 3642, sec. 3(a), S 308(a)(1) (to be codified as amended at 21 U.S.C. S 331 et seq.); S. 2 1 3 5 , sec. 3(a), 5 308(a) (to be codified as amended
at 21 U.S.C. S 331 et seq.). 41. See supra note 38. 42. See, e.g., Philip J. Hilts, U.S. Cracks Down on Health Devices Made Before 1976, N.Y. TIMES, Feb. 24, 1992, at AI. 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 Value is presenting Patients With Harrowing Choice, N.Y. TIMES, March 14, 1992, at I. 43. Gina Kolata, 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. 44. See Sonni Efron, Heart Value Maker Offers to Settle Lawsuits, L.A. TIMES, Jan. 25, 1992 at AI. 45. 424 U.S. 3 19 (1976) (detailing a three factor balancing test of procedural due process which weighed: ( I ) 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). 46. SeeH.R. 3642, sec. 3,s 308(a)(1) (to be codified as amended at 21 U.S.C. 5 3 3 I et seq.). 47.See S. 2135, sec. 3(a), S 308(a) (to be codified as amended at 21 U.S.C. S 33 I et seq.). 48.See H.R. 3642, sec. 3(a), S 308(a)(1) (to be codified as amended at 21 U.S.C. 331 et seq.); S. 2135, sec. 3(a), S 308(a) (to be codified as amended at 21 U.S.C. 331 etseq.). 49. See FDA Held Too Weak in Report, CHEMICAL MARKETING REPORTER, Oct. 14, 1991, at 5. 5o.See Pub. L. No. 101-629, 104 Stat. 4511, 4520-21 (1990) (codified as amended at 21 U.S.C. 5 333(f)) (West Supp. 1991) (stating that fines are not to exceed $I 5,000 for each violation and are not in aggregate to be gr ater than $I million for a single procee ing). 51. Pub. L. No. 97-35, 95 Stat. 598 (1981) (codified as amended at 21 U.S.C.A. S 36opp(b)(1)) (West Supp. 1991) (transferred from 42 U.S.C. S 263(k)) (limiting liability under this statute to $1000 per separate violation and $300,000 for a related series of violations).
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gz.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 $zso,ooo for individuals and $ I 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.) (set-
s
ting 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 $IOO,OOO for corporations). 53.See H.R. 3642, sec. 6, 309(e) (to be codified as amended at ZI U.S.C. 331 etseq.); s. 2135, sec. 6 , $ 309(d) (to be codified as amended at 21 U.S.C. 331 etseq.).
s
s
s
54. Jeffrey P. Cohn, The Beginnings: Laboratory and Animal Studies, FROM TESTTUBE TO PATIENT: NEWDRUGDEVELOPMENT IN THE UNITEDSTATES, FDA publication, 6 , 7 (1990). 5 5 . See, e.g., NUTRITION LABELING AND EDUCATION ACI'OF 1990, Pub. I.. NO. LOI535, 104 Stat. 2353 (1990) (requiring the FDA to promulgate more stringent food labeling standards).
