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Regulation of Foods and Drugs and Libertarian Ideals: Perspectives of a Fellow-Traveler*

  • Daniel D. Polsby (a1)

For one with libertarian sympathies, the official regulation of foods and drugs is presumptively a bad thing. One is most accustomed to seeing the argument in debates about legalizing marijuana and other hedonic drugs. And it remains a very good if by now well-trafficked question, which will be more well-trafficked still by the time this essay ends, why government should be in the business of telling people what sorts of chemical moodenhancers they may take. But as the criminologist James Jacobs has pointed out, to ask this question is to put in play matters far larger and more important than marijuana. What business is it of government to say what medicines may be sold and by whom they may be sold? Why should certain chemical agents be available to willing buyers only with a doctor's scrip, and other agents, such as unproved drugs or devices, forbidden to all, even with medical permission? If libertarians answer these questions impatiently, then admirers of the administrative welfare state (“statists”) will be happy to play rope-a-dope with them, chattering on about the endearing eccentricities of libertarians' assumptions and avoiding the challenge to articulate and defend their own increasingly shabby-looking principles. Those principles are much in need of defense. Food and drug laws are among the most well-established offices of regulatory government. They are complicated, hypertechnical, mysterious, and expensive to administer and maintain. One is entitled to suspect that a number of them are carried on more out of habit and routine than out of any authentic conviction that they are the best way, or among the better ways, to provide for the welfare of citizens.

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1 Jacobs, James B., “Imagining Drug Legalization,” The Public Interest, vol. 101 (1990), p. 31.

2 Blumstein, Alfred, “Youth Violence, Guns, and the Illicit Drug Industry,” Journal of Criminal Law and Criminology, vol. 86 (1995).

3 United States v. Dotterweich, 320 U.S. 277 (1943).

4 A superb treatise on this subject is: Adams, John G. U., Risk (London: UCL Press, 1995).

5 Buss, David, The Evolution of Desire (New York: Basic Books, 1994).

6 Pope, N. C. and Katz, D. L., “Affective and Psychotic Symptoms Associated with Anabolic Steroid Use,” American Journal of Psychiatry, vol. 145 (1988); Perry, P., Anderson, K., and Yates, W., “Illicit Anabolic Steroid Use in Athletes: A Case Series Analysis,” American Journal of Sports Medicine, vol. 18 (1990); Brower, K., Blow, F., Young, J., and Hill, E., “Symptoms and Correlates of Anabolic-Androgenic Steroid Dependence,” British Journal of Addiction, vol. 86 (1990); Pope, N. C. and Katz, D. L., “Homicide and Near Homicide by Anabolic Steroid Users,” Journal of Clinical Psychiatry, vol. 51 (1990); see also Buckley, W. E. et al. , “Estimated Prevalence of Anabolic Steroid Use among Male High School Seniors,” Journal of the American Medical Association, vol. 260 (1988), pp. 3441–45.

7 Hence, an “anabolic steroid” defense against a charge of assault would probably be useless.

8 See, e.g., Yudofsky, Stuart, Silver, Jonathan, and Hales, Robert, “Cocaine and Aggressive Behavior: Neurobiological and Clinical Perspectives,” Bulletin of the Menninger Clinic, vol. 57 (1993).

9 Because of her work on thalidomide, Dr. Kelsey was awarded the President's Gold Medal for Distinguished Service. See Kazman, Sam, “Deadly Overcaution: FDA's Drug Approval Process,” Journal of Regulation and Social Costs, vol. 1 (1990), p. 36.

10 Thalidomide still remains a substantial mystery. One researcher has stated: “There were 800 studies after the thalidomide disaster, but teratologists still do not know how that one drug causes limb reduction in the human embryo. They haven't even found the active part of the molecule in thalidomide or determined where it strikes during gestation.” Dowie, Mark, “Teratology: The Loneliest Science,” American Health, 06, 1990, p. 58.

11 Some abnormalities in boys were also reported. DES has spawned a great deal of litigation and made some important law on the subject of joint causation and liability. See, e.g., Sindell v. Abbott Laboratories, 607 P.2d 924 (California Supreme Court, 1980); and Hymowitz v. Eli Lilly & Co., 539 N.E.2d 1069 (New York Court of Appeals, 1989).

12 Stinton, C. M., “Preliminary Indications that Functional Effects of Fetal Caffeine Exposure Can Be Expressed in a Second Generation,” Neurotoxicology and Teratology, vol. 11 (0708 1989), pp. 357–62.

13 Otherwise, occasions for governmental intervention in any person's behavior would multiply without limit, on the ground that a given regulation was nothing more than a protection for the rights of persons unborn and unbegotten.

14 Investor's Business Daily, 02 10, 1997.

15 See generally Blumberg, Henry, Rimland, David, Carroll, Donna, Terry, Pamela, and Wachsmuth, Kaye, “Rapid Development of Ciprofloxacin Resistance in Methicillin-Susceptable and -Resistant Staphylococcus aureus,” Journal of Infectious Diseases, vol. 163 (1991); Cohen, Mitchell, “Epidemiology of Drug Resistance: Implications for a Post-Microbial Era,” Science, vol. 257 (1992); and Neu, Harold, “The Crisis in Antibiotic Resistance,” Science, vol. 257 (1992). See also, among many other authorities, Muder, Robert, Brennen, Carole, Goetz, Angella, Wagener, Marilyn, and Rihs, John, “Association with Prior Fluoroquinolone Therapy of Widespread Ciprofloxacin Resistance among Gram-Negative Isolates in a Veterans Affairs Medical Center,” Antimicrobial Agents and Chemotherapy, vol. 35 (1991); Gaynes, Robert, Weinstein, Robert, Chamberlin, William, and Kabins, Sherwin, “Antibiotic-Resistant Flora in Nursing Home Patients Admitted to the Hospital,” Archives of Internal Medicine, vol. 145 (1985); Murray, Barbara, “New Aspects of Antimicrobial Resistance and the Resulting Therapeutic Dilemmas,” Journal of Infectious Diseases, vol. 163 (1991); and O'Brien, Thomas et al. , “Resistance of Bacteria to Antibacterial Agents: Report of Task Force 2,” Reviews of Infectious Diseases, vol. 9 (1987).

16 In discussion.

17 Holmberg, Scott, Solomon, Steven, and Blake, Paul, “Health and Economic Impacts of Anti-Microbial Resistance,” Reviews of Infectious Diseases, vol. 9 (12 1987), pp. 1065–77.

18 197 U.S. 11 (1905).

19 Elster, Jon, ed., The Multiple Self (New York: Cambridge University Press, 1986), p. 3.

20 Schelling, Thomas, “The Intimate Contest for Self-Command,” The Public Interest, vol. 60 (1980).

21 United States v. Rutherford, 442 U.S. 544, 551–52 (1979).

22 However, the FDA has suspended its policy of seizing nonapproved drugs imported from other countries, so a patient with sufficient resources may be able to obtain the desired medication from abroad. Hutt, Peter, “The Regulation of Pharmaceutical Products in the U.S.A.,” in Pharmaceutical Medicine, ed. Burley, Denis M. et al. , 2d ed (London and Boston: E. Arnold, 1993), pp. 216–17.

23 Kolata, Gina, “Sharp Debate on Value of an Alzheimer's Drug,” New York Times, 04 4, 1991, p. B1. Tacrine was eventually approved in September 1993 (FDA Electronic Bulletin Board, 09 9, 1993).

24 Statistical Abstract of the United States, 1995 National Data Book (Washington, DC: Government Printing Office, 1995), p. 92, table 125.

25 Shapiro, Eben, “Fat Substitutes: The Long, Hard Quest for Foods That Fool the Palate,” New York Times, 09 29, 1991, p. C5.

26 Burros, Marian, “FDA Advisory Panel Backs Approval of a Fat Substitute,” New York Times, 11 18, 1995, p. A11.

27 Washington Post, 02 2, 1997, p. F13.

28 Wardell, William M., “A Close Inspection of the ‘Calm Look’,” Journal of the American Medical Association, vol. 239 (1978), p. 2010.

29 Wardell, William M. and Lasagna, Louis, Regulation and Drug Development (Washington, DC: American Enterprise Institute, 1975), p. 77.

30 Schwartz, H., “A ‘Miracle’ Drug That Languished among the Worms,” Wall Street Journal, 07 18, 1989, p. A22.

31 Wardell, , “A Close Inspection,” p. 2010.

32 Kazman, , “Deadly Overcaution” (supra note 9), p. 47.

33 Ibid., p. 49.

34 “TPA: The Tip of the Iceberg,” Wall Street Journal, 12 2, 1987, p. A12.

35 Wardell, and Lasagna, , Regulation and Drug Development, pp. 7273.

36 When a class of victims is organized and alert, as AIDS victims have been and cancer patients have become, they can, of course, often win special, fast-track concessions from the agency. See generally Larson, Elizabeth, “Unequal Treatments,” Reason, 04 1992, p. 48; Kolata, Gina, “Trial of Experimental AIDS Drug to Be Continued, with Revisions,” New York Times, 03 9, 1990, p. 1. It is an unusual situation when a disease strikes largely at a class of people who have pre-constituted themselves into a vocal, well-funded interest group, but lucky for those who have that disease rather than some other, equally serious or more serious disease whose victims have no political juice. See Kondracke, Morton, “How Diabetes Plan Was Hatched—And Why It Is Not Enough,” Roll Call Online,

37 DiMasi, J. A. et al. , “Cost of Innovation in the Pharmaceutical Industry,” Journal of Health and Economics, vol. 10 (1991), p. 126. The study estimated the probable range of costs to be between $197 million and $287 million.

38 The high research-and-development costs mandated by government approval have been cited as a reason for market consolidation and merger activity. See ibid., p. 108. During the late 1980s, several mergers within the pharmaceutical industry occurred, including SmithKline-Beecham, Bristol Myers-Squibb, and Merrell Dow-Marion Laboratories. See ibid., p. 108, n. 5.

39 Both of these comparisons probably understate the FDA's inefficiency, since they are comparisons against other bureaucratic monopolies rather than against competitive reviewing agencies.

40 Peltzman, Sam, Regulation of Pharmaceutical Innovation (Washington, DC: American Enterprise Institute, 1974), p. 18; Kazman, , “Deadly Overcaution,” p. 38.

41 See Crout, J. R., “Objectives and Achievements of Regulations in the U.S.A.,” and Griffin, J. P., “Objectives and Achievements of Regulations in the U.K.,” in International Medicines Regulations: A Forward Look to 1992, ed. Walker, Stuart R. and Griffin, John P. (Dordrecht: Kluwer, 1989), pp. 73, 87, 117, 130.

42 Statement of FDA Commissioner David Kessler, Hearings before the Senate Subcommittee on Labor and Human Resources, 104th Congress, 1st Session (1995).

43 Miller, Henry I., “FDA and Regulatory Reform,” San Francisco Chronicle, 03 10, 1995, p. A23; Wittes, Benjamin, “Has FDA Gotten Its Act Together?” Legal Times, 03 20, 1995, p. 5.

44 Peltzman, , Regulation of Pharmaceutical Innovation, p. 18.

45 Kaitlin, et al. , “The Drug Lag: An Update of New Drug Introductions in the United States and in the United Kingdom, 1977 through 1987,” Clinical Pharmacology and Therapeutics, vol. 46 (1989). The differences in speed of approval were the same for the first period in the study (1977–1982) as they were for the second period (1983–1987), indicating that the FDA was not improving relative to its British counterpart. See ibid., p. 135.

46 Hahn, Robert W. and Hird, John A., “The Costs and Benefits of Regulation: Review and Synthesis,” Yale Journal of Regulation, vol. 8 (1991), pp. 276–77; see also Peltzman, , Regulation of Pharmaceutical Innovation.

47 This is not hyperbole, unfortunately. See Harmelin v. Michigan, 501 U.S. 957 (1991).

48 See, e.g., the front-page story in the Sunday edition of the Montgomery (Alabama) Advertiser, 02 11, 1996.

49 The Clinton administration has requested $16 billion for the war on drugs for the 1998 fiscal year, an increase of $800 million over the 1997 appropriation. Chicago Tribune, 02 26, 1997, section 1, p. 14.

50 1995 Sourcebook of Criminal Justice Statistics (Washington, DC: U.S. Department of Justice, Bureau of Justice Statistics, 1995), p. 492.

51 Admittedly the foregoing numbers are not solid. Significant portions of the nominal budgets go toward dual-purpose items; for example, coastal-surveillance assets paid for by the war on drugs are useful in other budget lines without being reflected in them. Most of the criminals serving time for drug offenses are in prison on negotiated pleas, so that we cannot be certain what, exactly, they actually did to get into trouble. Few of them are Boy Scouts in any event, and might be locked up for something else if not for this. But though we should discount the numbers somewhat, they do give at least a rough feel for the edge of hysteria that this subject seems to provoke.

52 720 F.Supp. 1424 (N.D.Cal. 1989).

53 29 U.S.C. sections 701–795(i).

54 680 F.Supp. 590, 600 (S.D.N.Y. 1988).

55 29 U.S.C. section 1201, et seq.

56 See generally 22 ALR Fed 111 (1997).

57 539 N.Y.Supp.2d 876 (1989).

58 See, e.g., New York v. Jones, 350 N.E.2d 913 (N.Y.Ct.App. 1976).

59 A more extended account of what follows is given in Polsby, Daniel, “Ending the War on Drugs and Children,” Valparaiso Law Review, vol. 31 (1997).

* Thanks are owed to the research assistance of Kent Pflederer, Nathan Linn, and James Fitzpatrick, M.D. Thanks also to several colleagues for helpful comments, in particular Robert W. Bennett, Anthony D'Amato, Mayer Freed, Andy Koppelman, and Gary Lawson, all of whom are held harmless hereby. Acknowledgment is also due to the Kirkland & Ellis Research Fund, which subsidizes the author's research activities.

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