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Challenges in the Federal Regulation of Pain Management Technologies

Published online by Cambridge University Press:  01 January 2021

Lars Noah
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Extract

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). If a “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.

The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic.

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Article
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Journal of Law, Medicine & Ethics , Volume 31 , Issue 1 , Spring 2003 , pp. 55 - 74
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Copyright © American Society of Law, Medicine and Ethics 2003

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References

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See id. at 500–01 & n.2 (Stevens, J., concurring in judgment) (calling the majority's suggestion to the contrary dicta).Google Scholar
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See Oakland Cannabis, 532 U.S. at 502 n.4 (Stevens, J., concurring in judgment) (noting, in addition to California's law, the passage of voter initiatives in Alaska, Colorado, Maine, Nevada, Oregon, and Washington, along with legislative action in Hawaii); Tiersky, M., Comment, “Medical Marijuana: Putting the Power Where It Belongs,” Northwestern University Law Review, 93 (1999): 547–95, at 551, 578–84 (describing and defending these various state initiatives).Google Scholar
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See Trebach, A.S., The Heroin Solution (New Haven: Yale Univ. Press, 1982): At 59–84; Mondzac, A., “In Defense of the Reintroduction of Heroin into American Medical Practice and H.R. 5290 — The Compassionate Pain Relief Act,” N. Engl. J. Med., 311 (1984): 532–35, at 533; Shapiro, E.L., “The Right to Privacy and Heroin Use for Painkilling Purposes by the Terminally III Cancer Patient,” Arizona Law Review, 21 (1979): 41–59, at 43–48.Google Scholar
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In a related vein, the FDA at one time categorically refused to consider prior foreign use of an ingredient in food as providing evidence of the safety of a substance, but a court invalidated the policy because it found “no basis for a purely ethnocentric distinction of this kind, divorced from demographic considerations.” Fmali Herb, Inc. v. Heckler, 715 F.2d 1385, 1390 (9th Cir. 1983); see also Noah, L. & Merrill, R.A., “Starting from Scratch?: Reinventing the Food Additive Approval Process,” Boston University Law Review, 78 (1998): 329–443, at 354–55; Pinco, R.G., “Implications of FDA's Proposal to Include Foreign Marketing Experience in the Over-the-Counter Drug Review Process,” Food & Drug Law Journal, 53 (1998): 105–22.Google Scholar
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Congress may have set a similar precedent when it originally decided to classify cocaine as a Schedule II “narcotic” even though pharmacologically the substance does not qualify as a narcotic. See United States v. Whitley, 734 F.2d 1129, 1140–41 (6th Cir. 1984) (upholding the classification as rational in order to promote law enforcement purposes); United States v. Alexander, 673 F.2d 287 (9th Cir. 1982).Google Scholar
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See 37 Fed. Reg. 18,097 (1972), remanded, NORML v. Ingersoll, 497 F.2d 654, 660–61 (D.C. Cir. 1974), petition denied, 40 Fed. Reg. 44,164 (1975), remanded, NORML v. DEA, 559 F.2d 735, 757 (D.C. Cir. 1977), petition denied, 44 Fed. Reg. 36,123 (1979), remanded, NORML v. DEA, No. 79–1660 (D.C. Cir. Oct. 16, 1980), hearing announced, 51 Fed. Reg. 22,946 (1986), petition denied, 54 Fed. Reg. 53,767, 53,784 (1989) (The administrative law judge's conclusion that a ‘respectable minority’ of physicians is all that is necessary to establish accepted medical use in treatment in the United States is preposterous.”), remanded, ACT v. DEA, 930 F.2d 936, 940–41 (D.C. Cir. 1991).Google Scholar
See United States v. Greene, 892 F.2d 453, 455–56 (6th Cir. 1989); Pearson v. McCaffrey, 139 F. Supp. 2d 113, 120–23 (D.D.C. 2001); NORML v. Bell, 488 F. Supp. 123, 132–43 (D.D.C. 1980) (three-judge court); cf. Washington v. Glucksberg, 521 U.S. 702, 791 (1997) (Breyer, J., concurring in the judgment) (suggesting that the Court might hold it unconstitutional “were state law to prevent the provision of palliative care, including the administration of drugs as needed to avoid pain at the end of life”); Burt, R.A., “The Supreme Court Speaks: Not Assisted Suicide but a Constitutional Right to Palliative Care,” N. Engl. J. Med., 337 (1997): 1234–36. A lower federal court once found a fundamental right to receive acupuncture treatment. See Andrews v. Ballard, 498 F. Supp. 1038, 1047–57 (S.D. Tex. 1980) (invalidating a state's licensing restriction).Google Scholar
Cf. United States v. McMahon, 861 F.2d 8, 11 (1st Cir. 1988) (noting the “organic-synthetic distinction in Schedule I” between marijuana and THC). Of course, similar concerns did not dissuade the agency from its ill-fated effort to assert regulatory jurisdiction over cigarettes containing variable quantities of the drug nicotine from tobacco leaves. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000); Noah, L. & Noah, B.A., “Nicotine Withdrawal: Assessing the FDA's Effort to Regulate Tobacco Products,” Alabama Law Review, 48 (1996): 1–63.Google Scholar
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54 Fed. Reg. 53,767, 53,784 (1989). On the pitfalls of relying on the biomedical literature in this fashion, see Noah, L., “Sanctifying Scientific Peer Review: Publication as a Proxy for Regulatory Decisionmaking,” University of Pittsburgh Law Review, 59 (1998): 677–717.Google Scholar
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See United States v. Cannabis Cultivators Club, 5 F. Supp. 2d 1086, 1105 (N.D. Cal. 1998). Four years later, HHS again recommended against down-scheduling marijuana. See Gettman v. DEA, 290 F.3d 430, 432 (D.C. Cir. 2002) (holding that the petitioners lacked standing to challenge the DEA's subsequent rejection of their request).Google Scholar
See Hilts, R.J., “After Two-Decade Halt, Marijuana Research Is Set,” New York Times, Dec. 15, 2001, at A16; see also Robichaux, M., “Would Marijuana Be OK by Prescription If You Didn't Get High?,” Wall Street Journal, Feb. 28, 2001, at A1 (“Recent findings suggest that THC holds more potential as a painkiller than anyone ever guessed.”).Google Scholar
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See 57 Fed. Reg. at 10,504–07 (also requiring that the drug's chemistry be known and reproducible); id. at 10,505 (“When a drug lacks NDA approval and is not accepted by a consensus of experts outside FDA, it cannot be found … to have a currently accepted medical use.”). The DEA had first described these factors a few years earlier, but in combination with a few others, see 53 Fed. Reg. 5156, 5157–58 (1988) (classifying methylenedioxymethamphetamine (MDMA), commonly known as Ecstasy, as a Schedule I controlled substance), 54 Fed. Reg. at 53,783–84, which the reviewing court rejected as unworkable, see ACT v. DEA, 930 F.2d at 940.Google Scholar
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See United States v. 50 Boxes More or Less, 909 F.2d 24, 26–28 (1st Cir. 1990) (sustaining an FDA enforcement action against an unapproved prescription drug for the treatment of vascular headaches); United States v. Seven Cardboard Cases … “Esgic with Codeine Capsules”, 716 F. Supp. 1221, 1224–25 (E.D. Mo. 1989).Google Scholar
See Grinspoon v. DEA, 828 F.2d 881, 886–91 (1st Cir. 1987) (rejecting the notion that the absence of FDA approval demonstrated the lack of a legitimate medical use); NORML v. DEA, 559 F.2d 735, 748–50 & n.65 (D.C. Cir. 1977); see also Reckitt & Colman, Ltd. v. DEA, 788 F.2d 22, 24 (D.C. Cir. 1986) (describing the DEA's decision to move buprenorphine, an opiate derivative, from Schedule II to Schedule V on the recommendation of HHS after the FDA approved the drug as an analgesic). After the remand in Grinspoon, the DEA adhered to its decision to place MDMA in Schedule I. See United States v. Carlson, 87 F.3d 440, 444–45 (11th Cir. 1996); cf. Weiss, R., “On Ecstasy, Consensus Is Elusive,” Washington Post, Sept. 30, 2002, at A7 (reporting that the FDA now has approved research — pending authorization from the DEA — into MDMA's possible efficacy as a treatment for post-traumatic stress disorder).Google Scholar
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See Grinspoon, 828 F.2d at 897. In connection with the DEA's decision to up-classify methamphetamine to Schedule II, the courts have rejected objections that HHS had done too cursory a medical and scientific review. See United States v. Lafoon, 978 F.2d 1183, 1184–85 (10th Cir. 1992).Google Scholar
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See Brushwood, D.B. & Carlson, J.J., “The Pharmacist's Responsibility to Evaluate Suspicious Prescriptions,” Food Drug Cosmetic Law Journal, 46 (1991): 467–85, at 481 (noting that the DEA's Pharmacist Manual lists as one indicia of an illegitimate prescription “whether the purported prescription order contains an indication other than one found in the package insert”); id. at 475 n.45 (“Pharmacists would have to question the appropriateness of virtually every prescription that is out of the ordinary, in a way that is inconsistent with the federal framework in which physicians are allowed wide latitude in prescribing.”); see also United States v. Leal, 75 F.3d 219, 223 (6th Cir. 1996) (upholding conviction of pharmacist); United States v. Hayes, 595 F.2d 258, 261 n.6 (5th Cir. 1979) (“[A] pharmacist can know that prescriptions are issued for no legitimate medical purpose without his needing to know anything about medical science.”).Google Scholar
See 21 U.S.C. § 396 (2000) (medical device regulation); 42 U.S.C. § 1395 (2000) (“Nothing in [Medicare] shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided.”); 37 Fed. Reg. 16, 503, 16, 504 (1972) (“[I]t is clear that Congress did not intend the [FDA] to regulate or interfere with the practice of medicine….”).Google Scholar
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In contrast, when a group of death row inmates petitioned the FDA in the early 1980s to restrict the off-label use of Schedule II drugs for lethal injection, that agency declined to exercise its enforcement discretion in deference to the choices made by state penal officials. See Heckler v. Chaney, 470 U.S. 821 (1985) (rejecting a challenge to the agency's decision); see also Noah, L., Letter, “Attorney General's Intrusion into Clinical Practice,” N. Engl. J. Med., 346 (2002): 1918.Google Scholar
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For instance, alternative modes of delivery for other pharmaceutical products may reflect attempts to reduce pain associated with their administration. See Chea, T., “Medlmmune's Pain-Free Ambitions: If Approved by the FDA, FluMist Would Become First Vaccine Delivered as a Nasal Spray,” Washington Post, Mar. 18, 2002, at E1.Google Scholar
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See White, J., “OxyContin Abuse Is Increasing, DEA Says,” Washington Post, Dec. 12, 2001, at A10; see also Adams, C., “FDA Asks Maker of OxyContin to Pull ‘Misleading’ Print Ads,” Wall Street Journal, Jan. 23, 2003, at D3; Carter, J., “Senate Committee Examines Marketing Practices of OxyContin Manufacturer,” Associated Press Newswire, Feb. 12, 2002.Google Scholar
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See American Pharm. Ass’n v. Weinberger, 377 F. Supp. 824, 831 (D.D.C. 1974) (invalidating the FDA's effort to restrict the distribution of methadone, primarily because Congress had assigned this responsibility to the DEA), aff’d, 530 F.2d 1054 (D.C. Cir. 1976); Noah, L., “A Miscarriage in the Drug Approval Process? Mifepristone Embroils the FDA in Abortion Politics,” Wake Forest Law Review, 36 (2001): 571–603, at 584–86; see also Kaufman, M., “FDA Reapproves Bowel Drug After Pulling It for Safety,” Washington Post, June 8, 2002, at A4; Kritz, RL, “FDA to Weigh New Controls on Problematic Drugs,” Washington Post, Apr. 16, 2002, at Z1.Google Scholar
Methadone represents an exception. See Molinari, S.R. et al., “Federal Regulation of Clinical Practice in Narcotic Addiction Treatment: Purposes, Status, and Alternatives,” Journal of Law, Medicine & Ethics, 22 (1994): 231–39, at 238 (“The [Narcotic Addict Treatment Act of 1974] has created a closed distribution system unique to pharmacotherapy and the practice of medicine.”).CrossRefGoogle Scholar
See Noah, L., “Administrative Arm-Twisting in the Shadow of Congressional Delegations of Authority,” Wisconsin Law Review (1997): 873–941, at 881–82.Google Scholar
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See Cleeland, C.S., Editorial, “Undertreatment of Cancer Pain in Elderly Patients,” JAMA, 279 (1998): 1914–15, at 1915 (noting that “the optimal management of pain and adverse effects of analgesics requires aggressive use of controlled substances, potentially raising fears of regulatory scrutiny”); Gillespie, C., “Getting OxyContin Can Be an Ordeal for Those Who Need It,” Los Angeles Times, Oct. 14, 2001, at A26; Recer, P., “Experts Say Cancer Pain Undertreated,” Associated Press Newswire, July 17, 2002 (describing the conclusions reached at a National Institutes of Health consensus conference on the subject).CrossRefGoogle Scholar
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See Henderson, J.A. Jr. & Twerski, A.D., “Drug Designs Are Different,” Yale Law Journal, 111 (2001): 151–81, at 168–72; Noah, L., “Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues,” Georgia Law Review, 32 (1997): 141–80, at 172–73. In fact, after the FDA authorized the reintroduction of Lotronex with restrictions on who may prescribe the drug, patients have found it difficult to secure. See Kritz, F. L., “Still Irritable, Still Waiting: After Return to Market, Lotronex Can Be Hard to Get,” Washington Post, Feb. 11, 2003, at Z1.CrossRefGoogle Scholar
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See Satel, S., Op-Ed, “Keeping OxyContin out of the Wrong Hands,” Boston Globe, Aug. 11, 2001, at A15; see also Kreling, D.H. et al., “The Effects of an Internal Analgesic Formulary Restriction on Medicaid Drug Expenditures in Wisconsin,” Medical Care, 27 (1989): 34–44, at 36–37, 42 (concluding that this approach to reducing the use of narcotic analgesics had limited success). In addition, one state has sued for reimbursement of Medicaid expenditures for overprescribing of the drug. See Reidy, M.T. & Brown, M.H., “Suit Targets State Firm That Makes OxyContin,” Hartford Courant, June 13, 2001, at A6.Google Scholar
See “OxyContin Maker Calls Plaintiffs’ Allegations Baseless, Pledges to Ensure Supply for Patients,” Product Safety & Liability Reporter, 29 (2001): 666–68, at 667.Google Scholar
See Meier, B., “U.S. Asks Painkiller Maker to Help Curb Wide Abuse,” New York Times, May 1, 2001, at A1 2. Along similar lines, the DEA regulations include a rule of last resort for the use of opioid analgesics, authorizing the administration of narcotics in hospital settings “to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.” 21 C.F.R. § 1306.07(c).Google Scholar
See Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations for 2002: Hearings Before a Subcomm. of the House Comm. on Appropriations, 107th Cong., at 334 (2001) (testimony of Donnie R. Marshall, Acting Administrator, DEA). Although reportedly not done at the agency's behest, the manufacturer decided to discontinue marketing its highest dosage form (160 mg). See White, J., “Shipment of Potent Pain Pills Suspended: Company Interrupts Sales of Strongest Dosage of OxyContin Because of Abuse,” Washington Post, May 12, 2001, at A9.Google Scholar
See DuPont, R.L. & DuPont, C.M., “The Treatment of Anxiety: Realistic Expectations and Risks Posed by Controlled Substances,” Journal of Law, Medicine & Ethics, 22 (1994): 206–14, at 212–13 (“When physicians and patients abuse the social ‘contract’ on drugs of abuse, they should be subjected to professional and legal sanctions because such transgressions pose potentially serious clinical and public health dangers.”); Kessler, D.A., “Regulating the Prescribing of Human Drugs for Nonapproved Uses Under the Food, Drug, and Cosmetic Act,” Harvard Journal on Legislation, 15 (1978): 693–760, at 737 (“Withdrawal of a drug that has value to a certain patient population because the drug may be misused by a larger population in effect imposes an unfair hardship on those patients who could use the drug safely and profitably.”); cf. Swayze v. McNeil Labs., Inc., 807 F.2d 464, 468, 471–72 (5th Cir. 1987) (rejecting the plaintiff's claim that, if the manufacturer could not reduce the risk that health care professionals would act negligently and administer excessive doses of fentanyl, it should have withdrawn the drug from the market).CrossRefGoogle Scholar
See Wesson, D.R. & Smith, D.E., “Prescription Drug Abuse: Patient, Physician, and Cultural Responsibilities,” Western Journal of Medicine, 152 (1990): 613–16, at 613 (“Prescription drug abuse is more difficult to conceptualize than the abuse of cocaine, marijuana, or even alcohol because there is the need for a balance between restricting access and maintaining availability in drug control policy.”); Wilford, B.B. et al., “An Overview of Prescription Drug Misuse and Abuse: Defining the Problem and Seeking Solutions,” Journal of Law, Medicine & Ethics, 22 (1994): 197–203, at 198 (“[U]nlike illicit drug abuse, programs to control prescription drug abuse appear to affect medical care as well…. Such a large collateral effect deserves careful thought….”); id. at 202 (calling this issue “the ‘social algebra’ of the system, that is, the extent to which undermedication of some individuals will be tolerated in exchange for reductions in overmedication of others”).Google Scholar
See White, J., “DEA Backs Medical Use of OxyContin,” Washington Post, Oct. 24, 2001, at A26.Google Scholar
See Linder, J.A. & Stafford, R.S., “Antibiotic Treatment of Adults with Sore Throat by Community Primary Care Physicians: A National Survey, 1989–1999,” JAMA, 286 (2001): 1181–86; McCaig, L.F. & Hughes, J.M., “Trends in Antimicrobial Drug Prescribing Among Office-Based Physicians in the United States,” JAMA, 273 (1995): 214–19. The latest surveys suggest that things have begun to improve. See McCaig, L.F. et al., “Trends in Antimicrobial Prescribing Rates for Children and Adolescents,” JAMA, 287 (2002): 3096–102.Google Scholar
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For instance, in response to the escalating prices of new drugs, some patients have turned to black markets (supplied by diversion and counterfeiting) as well as cross-border purchases, each of which creates potential quality control problems that have prompted federal intervention. See Noah, L., “NAFTA's Impact on the Trade in Pharmaceuticals,” Houston Law Review, 33 (1997): 1293–326, at 1307–09, 1311–14.Google Scholar
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