¹ The author thanks the people of Underwriters Laboratories, Inc. for their unstinting assistance far beyond the call of common courtesy. The author thanks especially Frank Brutomesso, Judy Lykins, Homer Pringle and Rick Titus. All errors, inferences and comparisons to the FDA are solely the responsibility of the author and in no way reflect the attitudes or opinions of Underwriters Laboratories, Inc.

² Kenneth I. Kaitan, associate director, Tufts Center for the Study of Drug Development, Tufts University, written testimony for the U.S. House Subcommittee on Oversight and Investigations, May 25, 1995.

³ The 2.4 years in 1991-93 was down from a high of 3.1 years in 1983-1985.

⁴ United States General Accounting Office, "FDA Drug Approval," October 1995.

⁵ David Masci with Steve Langdon, "Bill to Overhaul FDA Process Gets Nod from Panel," Congressional Quarterly, March 30, 1996, p. 887.

⁶ Robert M. Goldberg, adjunct scholar, American Enterprise Institute, "Why Kessler Must Go," Wall Street Journal, April 4, 1996.

⁷ Steve Langdon, "FDA Drug Approval Process May Undergo Surgery," Congressional Quarterly, January 27, 1996, p. 223.

⁸ Lydia Verheggen, "FDA Review Times: Not Making the Grade," Issue Analysis No. 23, Citizens for a Sound Economy, February 26, 1996, p. 3.

⁹ 21 USC 355(c)(1).

¹⁰ Sam Peltzman "conservatively" estimated that the 1962 amendments to the Food, Drug and Cosmetic Act, which required that new drugs be proven effective - not just safe - added a minimum of two years to the drug approval process. See Peltzman, Regulation of Pharmaceutical Innovation: The 1962 Amendments (Washington: American Enterprise Institute for Public Policy Research, 1974), p. 18.

¹¹ Sen. Kassebaum is quoted in Masci and Langdon, "Bill to Overhaul FDA Process Gets Nod from Panel." The Biotechnology Industry Association makes a similar estimate; see Pete Du Pont, "National Nanny on the Ballot," Washington Times, July 17, 1995.

¹² Testimony of Kenneth I. Kaitan.

¹³ Conversation with Robert M. Goldberg, senior research fellow at George Washington University Medical School's Center on Neuroscience and Medical Progress, November 12, 1996.

¹⁴ Sam Kazman, "Deadly Overcaution: FDA's Drug Approval Process," Journal of Regulation and Social Costs, August 1990, p. 43. The fatality figures were calculated by multiplying the length of time required to approve the new drug application by the number of lives the FDA claimed the therapy might save.

¹⁵ Kazman, "Deadly Overcaution," p. 44.

¹⁶ William M. Wardell and Louis Lasagna, Regulation and Drug Development (Washington: American Enterprise Institute, 1975), ch. VII, p. 73; an updated and condensed version of W. M. Wardell, "Introduction of New Therapeutic Drugs in the United States and Great Britain: An International Comparison," Clinical Pharmacology and Therapeutics, vol. 14, 1973, pp. 773-90.

¹⁷ Wardell and Lasagna, Regulation and Drug Development, pp. 111-12; and U.S. Congress, House Subcommittee on Science, Research and Technology of the Committee on Science and Technology, "Report on the Food and Drug Administration's Process for Approving New Drugs," 96th Congress, 1st session, 1980, p. 32, cited in Henry G. Grabowski and John M. Vernon, The Regulation of Pharmaceuticals: Balancing the Benefits and Risks (Washington: American Enterprise Institute, 1983), p. 46.

¹⁸ Interview with Dr. Richard Cummins, ABC News, "20/20," August 12, 1994, cited by Alan M. Slobodin, "The Real Problems with Health Care in America: While Dr. David Kessler's FDA Fiddles, Medical Approvals Lag and Americans Die," Legal Backgrounder, vol. 9, no. 36, October 28, 1994, Washington Legal Foundation, p. 2.

¹⁹ Telephone conversation with Dr. Robert Higgs, director of the Independent Institute, June 14, 1995. Higgs emphasizes the convoluted nature of U.S. drug approval.

²⁰ President Bill Clinton and Vice President Al Gore, "Reinventing Drug and Medical Device Regulations," National Performance Review, April 1995, pp. 2-3.

²¹ Carolyn Lockhead, "Deadly Over-Caution: FDA Assailed for Slow Testing of New Drugs;" San Francisco Chronicle, October 26, 1992, quoted in Michael I. Krauss, "Loosening the FDA's Drug Certification Monopoly: Implications for Tort Law and Consumer Welfare," George Mason Law Review, Spring 1996, p. 463.

²² American Electronics Association News Release, Washington, DC, June 23, 1994, quoted in Robert Higgs, "Wrecking Ball: FDA Regulation of Medical Devices," Cato Institute Policy Analysis No. 235, August 7, 1995, p. 34.

²³ Ibid., p. 34.

²⁴ Budget figures are from "Fiscal Year 1996 Justification of Estimates for Appropriations Committees for Food and Drug Administration," February 6, 1995, p. 9.

²⁵ Steve Langdon, "FDA Drug Approval Process May Undergo Surgery," Congressional Quarterly, January 27, 1996, p. 222.

²⁶ Ibid., pp. 11, 24.

²⁷ These 510(k) approval requirements are different from the premarket approval for a new device or new use, which requires the full approval process.

²⁸ Telephone conversation with Paul Tilton, Center for Devices and Radiological Health, FDA, April 26, 1996.

²⁹ Clinton and Gore, "Reinventing Drug and Medical Device Regulations," p. 17, and telephone conversation with Al Bracey, Division for Small Manufacturers' Assistance, Center for Devices and Radiological Health, FDA, September 18, 1996.

³⁰ Press release from Sen. Kassebaum's office, "Labor Committee Passes Comprehensive Reform of FDA with Strong Bipartisan Support," March 28, 1996.

³¹ Proceedings, Senate Committee on Labor and Human Relations, April 6, 1995, Hearings On the Line, pp. 2-8.

³² "A Summary of S.1477 as passed by the Senate Committee on Labor and Human Resources on March 28, 1996," Senate Labor and Human Resources Committee, p.1, pp. 2-8

³³ Telephone conversation with Anthony Habib, staff member for the House Commerce Committee, April 26, 1996. The bills are: Rep. Richard Burr (R-NC), H.R.3199, The Drug and Biological Products Reform Act; Rep. Joe Barton (R-TX), H.R.3201, The Medical Device Reform Act of 1996; and Rep. Scott Kluge (R-WI), H.R.3200, The Food Amendments and Animal Drug Amendments of 1996.

³⁴ All information is from the House Commerce Committee's section-by-section analyses of The Medical Device Reform Act of 1996, and The Drug and Biological Products Reform Act, provided to the author by Anthony Habib, April 26, 1996.

³⁵ "The Medical Device Reform Act of 1996: Section-by-Section Analysis," House Commerce Committee, p. 1.

³⁶ Proceedings, Senate Committee on Labor and Human Resources, April 6, 1995.

³⁷ Open letter to Congressman Wayne T. Gilchrest from Jeffrey N. South, Washington Times, March 13, 1996.

³⁸ Alexander Volokh, "Clinical Trials - Beating the FDA in Court," Reason, May 1995, p. 24.

³⁹ For drugs that aren't otherwise controlled because they are illegal, addictive or abused, the FDA determines whether a patient must have a prescription from a physician to purchase or use them. Under the system of private certification, patients would be free to purchase certified or uncertified drugs without a doctor's advice or permission and assume the risk - although manufacturers might want to restrict sales to physicians or to customers with prescriptions, and they would of course be liable for their own negligence. A comparison of the United States to countries with less regulated access to medicines concluded that the less regulated markets are no less safe - suggesting that regulation of drug use by prescription is ineffective, or no less effective than cautious consumers acting on their doctor's advice. See Sam Peltzman, "The Health Effects of Mandatory Prescriptions," Journal of Law & Economics, October 1987, pp. 207-38.

⁴⁰ W. H. Merrill is quoted in This Inventive Century: The Incredible Journey of Underwriters Laboratories (Northbrook, IL: Underwriters Laboratories, Inc., 1994), p. 5.

⁴¹ Senate Committee on Labor and Human Resources, April 6, 1995, Hearings on the Line, p. 61.

⁴² 1994 Annual Report, Underwriters Laboratories, Inc., (Northbrook, IL, Underwriters Laboratories, Inc.), p. 24.

⁴³ 1994 Annual Report, Underwriters Laboratories, p. 16.

⁴⁴ Telephone conversation with Al Abadir, OSHA employee, June 15, 1995.

⁴⁵ 1994 Annual Report, Underwriters Laboratories, p. 10.

⁴⁶ Ibid., p. 15.

⁴⁷ Telephone conversation with Frank Brutomesso, Underwriters Laboratories, June 27, 1995.

⁴⁸ "Method of Development, Revision and Implementation of UL Standards for Safety," Underwriters Laboratories, Inc., pp. 10-11.

⁴⁹ See Kazman, "Deadly Overcaution," and Robert Higgs, "How the FDA is Causing a Technological Exodus," Competitive Enterprise Institute, February 1995.

⁵⁰ Telephone conversation with Dr. Robert Higgs, June 14, 1995.

⁵¹ Proceedings, Senate Committee on Labor and Human Resources, April 6, 1995, p. 10.

⁵² Clinton and Gore, "Reinventing Drug and Medical Device Approval," p. 7.

⁵³ "UL - Testing for Public Safety: An Overview of Underwriters Laboratories," Underwriters Laboratories, Inc., p. 6.

⁵⁴ Telephone conversation with Homer Pringle, UL attorney, June 24, 1995.

⁵⁵ Thalidomide, a prescription sedative, was moving toward FDA approval in 1960. Approximately 2.5 million sample tablets were in the hands of U.S. physicians when the manufacturer announced that pregnant women in Europe taking the drug were giving birth to children with deformities. At the time, scientific knowledge of and testing for such side effects was limited, and the FDA had no special expertise in the area. After months of delay, the FDA acted decisively only when President Kennedy insisted. See Robert M. Goldberg, "Breaking Up the FDA's Medical Information Monopoly," Regulation, vol. 18, no. 2, 1995, p. 43.

⁵⁶ Wardell and Lasagna, Regulation and Drug Development, pp. 139-140.