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See 53 Fed. Reg. 46,204 (1988); see also 48 Fed. Reg. 5,852 (1983) (TFM for external analgesics), amended, 51 Fed. Reg. 27,360 (1986).Google Scholar

The TFM includes a number of warnings applicable to aspirin. See 53 Fed. Reg. at 46, 256 (to be codified at 21 C.F.R. § 343.50(c)). In addition, with the OTC drug review for internal analgesics still pending, the FDA promulgated a requirement that any nonprescription products containing aspirin include a special warning against use during pregnancy. See 55 Fed. Reg. 27,776, 27,784 (1990) (codified at 21 C.F.R. § 201.63(e)).Google Scholar

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See Molotsky, I., “Agency Approves Painkiller for Over-the-Counter Sales,” New York Times, May 19, 1984, at 1. The FDA recently proposed amending the internal analgesics TFM to include Ibuprofen, which would eliminate the need to continue filing applications for supplemental or abbreviated new drug approval for future OTC drug products containing this active ingredient. See 67 Fed. Reg. 54,139 (2002).Google Scholar

See Mays, G., “Pain-Killer Wars Can Be a Pain for Ailing Consumers,” Chicago Tribune, Nov. 24, 1995, at Bus. 1.Google Scholar

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See 50 Fed. Reg. 51,400, 51,401 (1985); see also Public Citizen Health Research Group v. Comm’r, FDA, 740 F.2d 21, 34–35 (D.C. Cir. 1984) (remanding for lower court to consider claim of unreasonable delay by the FDA in acting on a citizen petition urging it to require a warning of this risk); American Home Prods. Corp. v. Johnson & Johnson, 672 F. Supp. 135, 137–41 (S.D.N.Y. 1987) (offering a detailed account of the history behind the early Reye syndrome warning efforts).Google Scholar

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See 63 Fed. Reg. 56,789, 56,801–02 (1998) (codified at 21 C.F.R. § 201.322 (2002)) (warning against the use of internal analgesics in combination with heavy alcohol consumption); see also Benedi v. McNeil-P.P.C, Inc., 66 F.3d 1378, 1387, 1389 (4th Cir. 1995) (sustaining a negligence claim and punitive damage award against the seller of Tylenol where it had delayed submitting adverse reaction reports — concerning liver toxicity resulting from interactions between acetaminophen and alcohol — to the FDA during the OTC monograph review process for internal analgesics); Adams, C., “Makers of Rival Pain Relievers Trade Jabs on Safety,” Wall Street Journal, Sept. 18, 2002, at B1.Google Scholar

See Roth, S.H., Editorial, “Nonsteroidal Anti-inflammatory Drugs: Gastropathy, Deaths, and Medical Practice,” Annals of Internal Medicine, 109 (1988): 353–54; Wilcox, C.M. et al., “Striking Prevalence of Over-the-Counter Nonsteroidal Anti-Inflammatory Drug Use in Patients with Upper Gastrointestinal Hemorrhage,” Archives of Internal Medicine, 154 (1994): 42–46, at 42; Foreman, J., “Painkillers Often Take Toll on Stomach,” Boston Globe, July 8, 1996, at 25; Weber, J. & Schiller, Z., “Painkillers Are About to O.D.,” Business Week, Apr. 11, 1994, at 54. These two categories do not, however, exhaust the range of options. For example, the prescription drug tramadol (Ultram® and Ultracet®) qualifies as neither an NSAID nor an opioid analgesic. See Edwards, J.E. et al., “Combination Analgesic Efficacy: Individual Patient Data Meta-Analysis of Single-Dose Oral Tramadol Plus Acetaminophen in Acute Postoperative Pain,” Journal of Pain & Symptom Management, 23 (2002): 121–30.CrossRefGoogle Scholar

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Id. § 812(b)(2).Google Scholar

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See H.R. Rep. No. 91–1444 (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4577–79; NORML v. Ingersoll, 497 F.2d 654, 657 (D.C. Cir. 1974).Google Scholar

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See Russo, E., “Cannabis for Migraine Treatment: The Once and Future Prescription? An Historical and Scientific Review,” Pain, 76 (1998): 3–8. See generally Grinspoon, L. & Bakalar, J. B., Marihuana: The Forbidden Medicine, rev. ed. (New Haven: Yale Univ. Press, 1993); Mathre, M.L., ed., Cannabis in Medical Practice: A Legal, Historical and Pharmacological Overview of the Therapeutic Use of Marijuana (Jefferson, North Carolina: McFarland & Co., 1997).Google Scholar

See Meng, I.D. et al., “An Analgesia Circuit Activated by Cannabinoids,” Nature, 395 (1998): 381–83; Williamson, E.M. & Evans, F.J., “Cannabinoids in Clinical Practice,” Drugs, 60 (2000): 1303–14; Hotz, R.L., “Chemicals in Pot Cut Severe Pain, Study Says,” Los Angeles Times, October 27, 1997, at A1; see also Grinspoon, L. & Bakalar, J.B., “Marihuana as Medicine: A Plea for Reconsideration,” JAMA, 273 (1995): 1875–76.CrossRefGoogle Scholar

See Joy, J.E. et al., eds., Marijuana and Medicine: Assessing the Science Base (Washington, D.C.: National Academy Press, 1999): At 145 (concluding that cannabinoid drugs may have a therapeutic potential for pain relief); id. at 179 (“Until a nonsmoked rapid-onset cannabinoid drug delivery system becomes available, we acknowledge that there is no clear alternative for people suffering from chronic conditions that might be relieved by smoking marijuana, such as pain….”).Google Scholar

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

See Goodman, E., Editorial, “The Uses of Pot,” Washington Post, Aug. 4, 2001, at A23.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

See Bennett, T., “The British Experience with Heroin Regulation,” Law & Contemporary Problems, 51 (Winter 1988): 299–314.CrossRefGoogle Scholar

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

See Stoll, S.M., Comment, “Why Not Heroin? The Controversy Surrounding the Legalization of Heroin for Therapeutic Purposes,” Journal of Contemporary Health Law & Policy, 1 (1985): 173–94, at 190–93; see also id. at 179 (“Clearly, the United States maintains a model of drug control more suited to law enforcement than to medical concerns.”); Fitzgerald, P.W., Comment, “Members of Congress as Medical Experts: Heroin and the Compassionate Pain Relief Act,” St. Louis University Public Law Review, 6 (1987): 371–90.Google Scholar

See H.R. Rep. No. 98–534, at 5 (1984) (asking “whether the adverse health effects caused by diversion of a drug outweigh its therapeutic usefulness,” and concluding that methaqualone “has no unique therapeutic advantages over other available drugs and has a significantly higher incidence of and potential for abuse”), reprinted in 1984 U.S.C.C.A.N. 540, 543–44.Google Scholar

See Pub. L. No. 98–329, 98 Stat. 280 (1984).Google Scholar

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

See 21 U.S.C. § 811(b) (2000).Google Scholar

See id.; Touby v. United States, 500 U.S. 160, 162, 167 (1991) (noting that the parties characterized this provision as giving a “‘veto power’ to the Secretary of HHS”); American Pharm. Ass’n v. Weinberger, 377 F. Supp. 824, 831 n.16 (D.D.C. 1974) (explaining that the DEA “must first call upon FDA for its recommendation. The recommendations of FDA, insofar as they concern ‘scientific and medical matters’ relating to the ‘appropriate schedule, if any, under which such drug or substance should be listed’ are binding on the Attorney General.”), aff’d, 530 F.2d 1054 (D.C. Cir. 1976).Google Scholar

H.R. Rep. No. 91–1444 (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4589.Google Scholar

See Musto, D.F., The American Disease: Origins of Narcotic Control, 3d ed. (New York: Oxford Univ. Press, 1999); Barnett, R.E., Book Review, “Bad Trip: Drug Prohibition and the Weakness of Public Policy,” Yale Law Journal, 103 (1994): 2593–630 (reviewing Duke, S.B. & Gross, A.C., America's Longest War: Rethinking Our Tragic Crusade Against Drugs (New York: G.P. Putnam's Sons, 1993)); Luna, E.G., “Our Vietnam: The Prohibition Apocalypse,” DePaul Law Review, 46 (1997): 483–568; Nadelmann, E.A., “Drug Prohibition in the United States: Costs, Consequences, and Alternatives,” Science, 245 (1989): 939–47; Newcomb, M.D., “Substance Abuse and Control in the United States: Ethical and Legal Issues,” Social Science & Medicine, 35 (1992): 471–79.Google Scholar

See Noah, L., “Divining Regulatory Intent: The Place for a ‘Legislative History’ of Agency Rules,” Hastings Law Journal, 51 (2000): 255–323, at 301; Shapiro, S. & McGarity, T., “Reorienting OSHA: Regulatory Alternatives and Legislative Reform,” Yale Journal on Regulation, 6 (1989): 1–63, at 57–62.Google Scholar

See Inspector General Act, Pub. L. No. 95–452, 92 Stat. 1101 (1978) (codified as amended at 5 U.S.C. app. II (2000)); Gates, M.J. & Knowles, M.F., “The Inspector General Act in the Federal Government: A New Approach to Accountability,” Alabama Law Review, 36 (1985): 473–513; see also Noah, L., “Scientific ‘Republicanism’: Expert Peer Review and the Quest for Regulatory Deliberation,” Emory Law Journal, 49 (2000): 1033–83Google Scholar

See 49 U.S.C. § 1131 (2000); Wald, M., “Two Positions on Safety,” New York Times, Aug. 30, 1998, at A16; “The FAA Should Inspect Itself,” Washington Post, May 23, 1996, at A20; see also Wood, A.J. et al., “Making Medicines Safer — The Need for an Independent Drug Safety Board,” N. Engl. J. Med., 339 (1998): 1851–54, at 1852–53 (advocating the creation of a similar counterweight to the FDA in order to improve postmarket surveillance of drugs approved by the agency).Google Scholar

See, e.g., Merrill, R.A. & Francer, J.K., “Organizing Federal Food Safety Regulation,” Seton Hall Law Review, 31 (2000): 61–173; Allen, M. & Mintz, J., “Homeland Department May Take a Year to Take Shape,” Washington Post, Nov. 21, 2002, at A8.Google Scholar

See Mashaw, J. et al., Administrative Law: The American Public Law System, 4th ed. (St. Paul: West Group, 1998): At 21–28, 174–75; Meidinger, E., “Regulatory Culture: A Theoretical Outline,” Law & Policy, 9 (1987): 355–86, at 360, 372–74.Google Scholar

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

See 51 Fed. Reg. 17, 476, 17, 478 (1986) (synthetic dronabinol in sesame oil encapsulated in soft gelatin capsules); see also 47 Fed. Reg. 10, 080 (1982) (announcing the FDA's proposed rescheduling recommendation pending approval of the NDA); Cooper, R.M., “Therapeutic Use of Marihuana and Heroin: The Legal Framework,” Food Drug Cosmetic Law Journal, 35 (1980): 68–82, at 76–79 (defending the FDA's earlier recommendation against down-scheduling).Google Scholar

See 64 Fed. Reg. 35,928, 35,930 (1999).Google Scholar

See 57 Fed. Reg. 10,499, 10,507–08 (1992) (adding that, “[b]y any modern scientific standard, marijuana is no medicine”); id. at 10,503 (“Beyond doubt, the claims that marijuana is medicine are false, dangerous and cruel.”). Although one can understand the DEA Administrator's exasperated tone in once again denying the petition, the published explanation contains a surprising note of glibness and sarcasm.Google Scholar

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

See ACT v. DEA, 15 F.3d 1131, 1135–37 (D.C. Cir. 1994).Google Scholar

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

See 57 Fed. Reg. at 10,503–04.Google Scholar

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

See Rohde, D.D., “The Orphan Drug Act: An Engine of Innovation? At What Cost?,” Food & Drug Law Journal, 55 (2000): 125–43, at 138–39 (discussing the disagreement between the agencies over gamma hydroxybutyrate (GHB), which appears to be an effective treatment for narcolepsy but also facilitates date rapes); see also Pub. L. No. 106–172, § 3(a)(1), 114 Stat. 7, 8 (2000); Rubin, R., “Company Wants ‘Date Rape’ Drug Approved for Sleep Disorder Treatment,” USA Today, June 6, 2001, at 10D (describing compromise legislation that placed GHB into Schedule I for most purposes but Schedule III when used in FDA-approved studies); Zitner, A., “Date-Rape Drug OK’d to Treat Sleep Disorder,” Los Angeles Times, July 18, 2002, at A12 (reporting that the FDA approved GHB subject to stringent restrictions on patient access).Google Scholar

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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See Noah, L., “Constraints on the Off-Label Uses of Prescription Drugs,” Journal of Products & Toxics Liability, 16 (1994): 139–65, at 139–44.Google Scholar

See Cooper, J.R. et al., “Prescription Drug Diversion Control and Medical Practice,” JAMA, 268 (1992): 1306–10, at 1308–09.CrossRefGoogle Scholar

51 Fed. Reg. 17,476, 17,477 (1986) (adding, by way of explanation, that the “DEA has encountered practitioners who attempt to justify illegal or improper distribution or dispensing by claiming unique knowledge of a drug's effectiveness for a broad range of medical indications”). One decade later, the DEA announced a similar threat against any physicians in California who simply recommended the use of marijuana. See 62 Fed. Reg. 6,164 (1997).Google Scholar

See Galer, B.S. et al., “Individual Variability in the Response to Different Opioids: Report of Five Cases,” Pain, 49 (1992): 87–91; Portenoy, R.K., “Opioid Therapy for Chronic Nonmalignant Pain: Clinicians’ Perspective,” Journal of Law, Medicine & Ethics, 24 (1996): 296–309, at 298–99; see also Ripamonti, C. et al., “An Update on the Clinical Use of Methadone for Cancer Pain,” Pain, 70 (1997): 109–15.CrossRefGoogle Scholar

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See Departments of Commerce, Justice, and State, the judiciary, and Related Agencies Appropriations for 2002: Part 10 — OxyContin: Hearings Before a Subcomm. of the House Comm. on Appropriations, 107th Cong., at 19 (2001) (statement of Asa Hutchinson, Administrator, DEA) (“Federal laws and regulations do not attempt to define or set standards as to what constitutes ‘legitimate medical purpose’ or ‘the usual course of professional practice,’ the requisite elements of lawful prescriptions under the CSA and DEA regulations. Instead, DEA relies upon the medical community to make these determinations.”); see also Joranson, D.E. & Gilson, A.M., “Policy Issues and Imperatives in the Use of Opioids to Treat Pain in Substance Abusers,” Journal of Law, Medicine & Ethics, 22 (1994): 215–23, at 216 (describing the dronabinol restriction as an aberration).CrossRefGoogle Scholar

See 66 Fed. Reg. 56,607, 56,608 (2001) (adding, however, that “[p]ain management, rather than assisted suicide, has long been recognized as a legitimate medical purpose justifying physicians’ dispensing of controlled substances”); see also Steinbrook, R., “Physician-Assisted Suicide in Oregon: An Uncertain Future,” N. Engl. J. Med., 346 (2002): 460–64; Cordaro, J., Note, “Who Defers to Whom? The Attorney General Targets Oregon's Death with Dignity Act,” Fordham Law Review, 70 (2002): 2477–514; Trafford, A., “Don’t Dismiss This as Physician Paranoia,” Washington Post, Mar. 12, 2002, at Z1.CrossRefGoogle Scholar

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

See Oregon v. Ashcroft, 192 F. Supp. 2d 1077 (D. Or. 2002), appeal pending, No. 02–35587 (9th Cir. 2003).Google Scholar

In the less stringent schedules, some of the listed substances refer to particular formulations and dosage strengths. See 21 U.S.C. § 812(c)(III)(d) & (V); see also id. § 811(g)(1) (calling for the descheduling of any nonnarcotic substance used in an FDA-approved OTC drug product); United States v. Martinez, 950 F.2d 222, 223–24 (5th Cir. 1991) (construing this provision); United States v. Caperell, 938 F.2d 975, 978–79 (9th Cir. 1991).Google Scholar

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

See Mosser, K.H., “Transdermal Fentanyl in Cancer Pain,” American Family Physician, 45 (1992): 2289–94; see also Jeal, W. & Benfield, P., “Transdermal Fentanyl: A Review of Its Pharmacological Properties and Therapeutic Efficacy in Pain Control,” Drugs, 53 (1997): 109–38; Neighbors, D.M. et al., “Economic Evaluation of the Fentanyl Transdermal System for the Treatment of Chronic Moderate to Severe Pain,” Journal of Pain & Symptom Management, 21 (2001): 129–43.Google Scholar

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See Hutchinson statement, supra note 127, at 15–17; Kumar, A., “Prescription Drug Abuse Soars,” Los Angeles Times, Jan. 17, 2003, at A30. In 2001, the National Institute of Drug Abuse (NIDA) issued a report documenting startling levels of prescription drug abuse. See Fackelmann, K., “Health Campaign Takes Aim at Prescription Drug Abuse,” USA Today, Apr. 10, 2001, at D7; see also Vastag, B., “Mixed Message on Prescription Drug Abuse,” JAMA, 285 (2001): 2183–84, at 2184 (“At the same time that NIDA is raising alarm bells about abuse potential, new studies point to chronic underprescribing of appropriate pain relief and a low risk of addiction to prescription drugs.”).Google Scholar

See Aoki, N., “Abusing Pain Pills: Is Maker to Blame?,” Boston Globe, July 4, 2001, at D1; Editorial, “Curbing the OxyContin Scourge,” Pittsburgh Post-Gazette, May 30, 2001, at A11 (“OxyContin has provided long-lasting pain relief for hundreds of thousands of cancer patients and others suffering from chronic pain.”); see also Adams, C., “Painkiller's Sales Far Exceeded Maker's Plans,” Wall Street Journal, May 16, 2002, at D2.Google Scholar

See Tough, P., “The Alchemy of OxyContin,” New York Times Magazine, July 29, 2001, at 32; cf. Crocker v. Winthrop Lab., 514 S.W2d 429 (Tex. 1974) (allowing a tort claim to proceed against the seller of the prescription analgesic Talwin® (pentazocine) for misrepresenting it as nonaddictive).Google Scholar

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See White, J., “Va. Class-Action Suit Filed Against OxyContin Firm,” Washington Post, June 19, 2001, at A6; see also McCaulley v. Purdue Pharma, L.P. 172 F. Supp. 2d 803, 804–05 (W.D. Va. 2001) (summarizing the plaintiffs’ allegations in the course of resolving preliminary motions); Salisbury v. Purdue Pharma, L.P., 166 F. Supp. 2d 546, 548 (E.D. Ky. 2001); McCallister v. Purdue Pharma, L.P., 164 F. Supp. 2d 783, 787-88, 791–92 (S.D. W. Va. 2001); Ausness, R.C., “Will More Aggressive Marketing Practices Lead to Greater Tort Liability for Prescription Drug Manufacturers?,” Wake Forest Law Review, 37 (2002): 97–139, at 133–35. Opponents of efforts to down-classify marijuana make a similar argument — namely, that decriminalization for medical use will create a larger supply subject to possible diversion.Google Scholar

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

See Brushwood, D.B. & Fern, F.H., “Clozaril and the Threat of Product Liability: Defensive Drug Distribution Invites Regulatory Reform,” Journal of Products & Toxics Liability, 15 (1993): 145–62, at 145–46, 150, 158–59; Krause, J.H., “Accutane: Has Drug Regulation in the United States Reached Its Limits?,” Journal of Law & Health, 6 (1991): 1–29, at 18–23; Hurwitz, M.A., Note, “Bundling Patented Drugs and Medical Services: An Antitrust Analysis,” Columbia Law Review, 91 (1991): 1188–220, at 1192–95.Google Scholar

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

See Pasko, T. & Seidman, B., Physician Characteristics and Distribution in the US (Chicago: AMA Press, 2002): At 15, 18; see also “DEA Overreaches in Effort to Stop Abuse of Painkiller,” USA Today, June 13, 2001, at 16A (citing an estimate that “there are fewer than 4,000 certified pain specialists” in the United States).Google Scholar

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

See Marsa, L., “OxyContin Abuse May Curb Progress in Pain Field,” Los Angeles Times, Aug. 13, 2001, at S1; “Supermarket Chain Pulls Oxycontin,” Associated Press Newswire, Apr. 16, 2002.Google Scholar

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

See White, J., “More Warnings About OxyContin,” Washington Post, July 26, 2001, at B2.Google 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

See Gillis, J. & Connolly, C., “Emphasis on Cipro Worries Officials,” Washington Post, Oct. 19, 2001, at A17 (reporting that drug-resistant strains of bacteria may contribute to 70,000 deaths each year in the United States); see also U.S. Office of Technology Assessment, Impacts of Antibiotic-Resistant Bacteria, OTA-H-629 (Washington, D.C.: Government Printing Office, 1995); Cohen, M.L., “Epidemiology of Drug Resistance: Implications for a Post-Antimicrobial Era,” Science, 257 (1992): 1050–55.Google Scholar

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See Markow, S.B., Note, “Penetrating the Walls of Drug-Resistant Bacteria: A Statutory Prescription to Combat Antibiotic Misuse,” Georgetown Law Journal, 87 (1998): 531–62, at 546–47 (suggesting that only infectious disease specialists in hospitals be permitted to use new antibiotics).Google Scholar

See 65 Fed. Reg. 24,704, 24,705 (2000) (“How should the risks and benefits to individuals and risks and benefits to the public health be assessed and weighed in any decision on OTC marketing? For example, how should the agency balance the potential benefits of OTC antimicrobial agents with the potential risks to society at large of the development of resistant organisms associated with increased, and potentially improper, use?”).Google Scholar

See Noah, L., “Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community,” Arizona Law Review, 44 (2002): 373–466, at 438–42; see also Moore, T.J. et al., “Time to Act on Drug Safety,” JAMA, 279 (1998): 1571–73, at 1572 (“[N]ew warnings about the addictive properties of propoxyphene had no effect on either prescription volume or the number of overdose deaths.”).Google Scholar

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See Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002) (invalidating a restriction on advertising by pharmacists who compound drug products); Noah, L., “What's Wrong with ‘Constitutionalizing Food and Drug Law,’” Tulane Law Review, 75 (2000): 137–48 (discussing litigation challenging the FDA's restrictions on indirect industry efforts to promote off-label drug uses).Google Scholar

See OxyContin — It's Use and Abuse: Hearing Before the Subcomm. on Oversight & Investigations of the House Comm. on Energy & Commerce, 107th Cong., at 9 (2001) (statement by Terrance W. Woodworth, Deputy Director, DEA Office of Diversion Control) (“[T]he five states with the lowest number of per capita OxyContin® prescriptions all have long standing prescription monitoring programs in place.”); see also Brushwood, D., “Maximizing the Value of Electronic Prescription Monitoring Programs,” Journal of Law, Medicine & Ethics, 31 (2003): 41–54. Doctors and drug companies generally oppose such programs. See Petersen, M. & Meier, B., “Few States Track Prescriptions as Way to Prevent Overdoses,” New York Times, Dec. 21, 2001, at A1.Google Scholar

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