Challenges in the federal regulation of pain management technologies

Journal of Law, Medicine and Ethics

Volumn 31, Issue 1, 2003, Pages 55-74

  Noah, Lars ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; NON PRESCRIPTION DRUG;

APPARATUS, EQUIPMENT AND SUPPLIES; DRUG CONTROL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE AND PUBLIC HEALTH; HUMAN; LEGAL APPROACH; LEGAL ASPECT; MARKETING; PAIN; PHARMACEUTICS; REVIEW; UNITED STATES;

HEALTH CARE AND PUBLIC HEALTH; LEGAL APPROACH;

ANALGESICS; DRUG AND NARCOTIC CONTROL; DRUGS, NON-PRESCRIPTION; EQUIPMENT AND SUPPLIES; FEDERAL GOVERNMENT; HUMANS; MARKETING; PAIN; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UNITED STATES GOVERNMENT AGENCIES;

EID: 0041758560     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2003.tb00059.x     Document Type: Review

References (419)

1. See J.A. Page, "Book Review," Food & Drug Law Journal, 47 (1992): 459-81
2. (reviewing C.C. Mann & M.L. Plummer, The Aspirin Wars: Money, Medicine, and 100 Years of Rampant Competition (New York: Knopf, 1991));
3. J.R. McTavish, "What's in a Name? Aspirin and the American Medical Association," Bulletin of the History of Medicine, 61 (1987): 343-66.
4. See generally J. Liebenau, Medical Science and Medical Industry: The Formation of the American Pharmaceutical Industry (Baltimore: Johns Hopkins Univ. Press, 1987). A few years earlier, Bayer had synthesized heroin for possible use as an analgesic.
5. See R.A. Merrill, "The Architecture of Government Regulation of Medical Products," Virginia Law Review, 82 (1996): 1753-866, at 1759-61;
6. see also United States v. Doremus, 249 U.S. 86 (1919) (rejecting a constitutional challenge to the Harrison Narcotic Act of 1914).
7. See generally L. Noah &: B.A. Noah, Law, Medicine, and Medical Technology: Cases and Materials (New York: Foundation Press, 2002).
8. See M.J. Field & C.K. Cassel, eds., Approaching Death: Improving Care at the End of Life (Washington, D.C.: National Academy Press, 1997): at 190-98;
9. H. McIntosh, "Regulatory-Barriers Take Some Blame for Pain Undertreatment," Journal of the National Cancer Institute, 83 (1991): 1202-04;
10. see also A.M. Gilson and D.E. Joranson, "Controlled Substances and Pain Management: Changes in Knowledge and Attitudes of State Medical Regulators," Journal of Pain & Symptom Management, 21 (2001): 227-37 (finding some signs of improvement).
11. See Drug Amendments of 1962, Pub. L. No. 87-781, § 102, 76 Stat. 780, 781 (codified as amended in scattered sections of 21 U.S.C.);
12. M.P. van Huysen, "Reform of the New Drug Approval Process," Administrative Law Review, 49 (1997): 477-99;
13. Note, "Drug Efficacy and the 1962 Drug Amendments," Georgetown Law Journal, 60 (1971): 185-224;
14. see also Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (codified as amended in scattered sections of 21 U.S.C.);
15. P.B. Hutt et al., "The Standard of Evidence Required for Premarket Approval Under the Medical Device Amendments of 1976," Food & Drug Law Journal, 47 (1992): 605-28.
16. See, e.g., United States v. Universal Mgmt. Serv., Inc., 191 F.3d 750, 754-55 (6th Cir. 1999) (electric stimulators);
17. United States v. An Article . . . Acu-Dot, 483 F. Supp. 1311, 1313-15 (N.D. Ohio 1980) (magnets);
18. United States v. Articles of Device (Acuflex; Pro-Med), 426 F. Supp. 366 (W.D. Pa. 1977) (electric acupuncture devices);
19. see also P.B. Hutt, "A History of Government Regulation of Adulteration and Misbranding of Medical Devices," Food Drug Cosmetic Law Journal, 44 (1989): 99-117.
20. Although initially it had proposed treating acupuncture needles as investigational devices, see 44 Fed. Reg. 63, 292, 63, 299 (1979), the FDA eventually issued a classification regulation, see 61 Fed. Reg. 64,616 (1996) (codified at 21 C.F.R. § 880.5580 (2002)).
21. See A. Hróbjartsson & P.C. Gøtzsche, "Is the Placebo Powerless? An Analysis of Clinical Trials Comparing Placebo with No Treatment," N. Engl. J. Med., 344 (2001): 1594-602, at 1596-97;
22. D.J. Rowbotham, "Endogenous Opioids, Placebo Response, and Pain," Lancet, 357 (2001): 1901-02;
23. J.A. Turner et al., "The Importance of Placebo Effects in Pain Treatment and Research," JAMA, 271 (1994): 1609-14;
24. see also S. Hoffman, "The Use of Placebos in Clinical Trials: Responsible Research or Unethical Practice?," Connecticut Law Review, 33 (2001): 449-501, at 497 (defending the use of placebos in clinical trials of investigational drugs to treat moderate pain, but only under limited circumstances).
25. See J.T. Farrar et al., "Clinical Importance of Changes in Chronic Pain Intensity Measured on an 11-Point Numerical Pain Rating Scale," Pain, 94 (2001): 149-58;
26. E.S. Pryor, "Compensation and the Ineradicable Problems of Pain," George Washington Law Review, 59 (1991): 239-306, at 246-57;
27. S. Rich, "Seeking to End Disability Fraud, Government Lays Hands on Pain: Experts Seek Ways to Measure True Extent of Impairment," Washington Post, Feb. 3, 1986, at A13;
28. E. Rosenthal, "Chronic Pain Fells Many Yet Lacks Clear Cause," New York Times, Dec. 29, 1992, at C1.
29. See generally G.M. Aronoff, ed., Evaluation and Treatment of Chronic Pain, 3d ed. (Baltimore: Williams & Wilkins, 1999).
30. See R.A. Moore et al., "Size Is Everything - Large Amounts of Information Are Needed to Overcome Random Effects in Estimating Direction and Magnitude of Treatment Effects," Pain, 78 (1998): 209-16.
31. Cross-over designs may facilitate comparisons against placebo or active controls. See FDA Center for Drug Evaluation & Research, Guideline for the Clinical Evaluation of Analgesic Drugs, Docket No. 91D-0425 (Dec. 1992): at 7-8 ("The salient advantage of crossover designs lies in the potential for reduction of experimental intersubject variation...."), available at 〈http:// www.fda.gov/cder/guidance/old041fn.pdf〉;
32. see also M.B. Max et al., Advances in Pain Research and Therapy: The Design of Analgesic Clinical Trials (New York: Raven Press, 1991);
33. J.A. Forbes, "Diflunisal: A New Oral Analgesic with an Unusually Long Duration of Action," JAMA, 248 (1982): 2139-42;
34. A.R. Jadad et al., "Morphine Responsiveness of Chronic Pain: Double-Blind Randomised Crossover Study with Patient-Controlled Analgesia," Lancet, 339 (1992): 1367-71;
35. S. Mercadante et al., "Analgesic Effect of Intravenous Ketamine in Cancer Patients on Morphine Therapy: A Randomized, Controlled, Double-Blind, Crossover, Double-Dose Study," Journal of Pain & Symptom Management, 20 (2000): 246-52;
36. D.E. Moulin et al., "Randomised Trial of Oral Morphine for Chronic Non-Cancer Pain," Lancet, 347 (1996): 143-47.
37. L. Noah, "Pigeonholing Illness: Medical Diagnosis as a Legal Construct," Hastings Law Journal, 50 (1999): 241-307, at 261.
38. See id. at 263 ("If only regarded as a symptom, proposed new ... treatments will fare less well in the agency's risk-benefit calculus and product approval decisions in the future.");
39. cf. M. Segal, Comment, "Overdue Process: Why Denial of Physician-Prescribed Marijuana to Terminally Ill Patients Violates the United States Constitution," Seattle University Law Review, 22 (1998): 235-63, at 258 (crafting a constitutional argument for medical use of marijuana in part by downplaying the state's regulatory-interest because, "unlike other controversial drugs such as laetrile, [which patients foolishly may select in lieu of conventional therapies,] marijuana is not being advanced as a cure for any of the diseases in question, but merely as a painkiller").
40. Cf. J.C. Liebeskind, "Pain Can Kill," Pain, 44 (1991): 3-4.
41. See E. Fox, Editorial, "Predominance of the Curative Model of Medical Care: A Residual Problem," JAMA, 278 (1997): 761-63, at 762 ("[P]alliative care medicine is often intensely-concerned with the treatment of pain, despite the fact that pain cannot be definitively verified and at times cannot even be explained.").
42. See B.A. Rich, "A Prescription for the Pain: The Emerging Standard of Care for Pain Management," William Mitchell Law Review, 26 (2000): 1-91;
43. R.J. Oken, Note, "Curing Healthcare Providers' Failure to Administer Opioids in the Treatment of Severe Pain," Cardozo Law Review, 23 (2002): 1917-92.
44. See S.G. Stolberg, "New Painkiller Is Withdrawn After Four Deaths," New York Times, June 23, 1998, at A1;
45. see also M. Kaufman, "Report Says Drugmakers Innovate Less, Modify More," Washington Post, May 29, 2002, at A5.
46. See E. Elhauge, "The Limited Regulatory Potential of Medical Technology Assessment," Virginia Law Review, 82 (1996): 1525-622, at 1593;
47. M.J. Mehlman, "Health Care Cost Containment and Medical Technology: A Critique of Waste Theory," Case Western Reserve Law Review, 36 (1986): 778-877, at 788 (explaining that the FDA "has occasionally, albeit rarely, denied approval to market a drug on the basis that it was less safe or less effective than an alternative already on the market").
48. See S. Hensley, "FDA Approves Pharmacia's Bextra Months Sooner Than Expected," Wall Street Journal, Nov. 19, 2001, at B5 (adding that the FDA has begun to approve newer versions).
49. See J.N. Cashman, "The Mechanisms of Action of NSAIDs in Analgesia," Drugs, 52, suppl. 5 (1996): 13-23.
50. See M.J. Langman et al., "Risks of Bleeding Peptic Ulcer Associated with Individual Non-Steroidal Anti-Inflammatory Drugs," Lancet, 343 (1994): 1075-78;
51. M.M. Wolfe et al., "Gastrointestinal Toxicity of Non-Steroidal Anti-Inflammatory Drugs," N. Engl. J. Med., 340 (1999): 1888-99.
52. See C. Bombardier et al., "Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis," N. Engl. J. Med., 343 (2000): 1520-28;
53. M.J. Langman et al., "Adverse Upper Gastrointestinal Effects of Rofecoxib Compared with NSAIDs," JAMA, 282 (1999): 1929-33;
54. L.S. Simon et al., "Anti-Inflammatory and Upper Gastrointestinal Effects of Celecoxib in Rheumatoid Arthritis: A Randomized Controlled Trial," JAMA, 282 (1999): 1921-28.
55. But see P. Jüni et al., Editorial, "Are Selective COX 2 Inhibitors Superior to Traditional Non Steroidal Anti-Inflammatory Drugs?," British Medical Journal, 324 (2002): 1287-88.
56. See D. Mukherjee et al., "Risk of Cardiovascular Events Associated with Selective COX-2 Inhibitors," JAMA, 286 (2001): 954-59, at 958;
57. see also R.A. Bonnel et al., "Asceptic Meningitis Associated with Rofecoxib," Annals of Internal Medicine, 162 (2002): 713-15;
58. L. Neergaard, "Painkillers May Delay Bone Healing," Associated Press Newswire, May 27, 2002 (reporting on research that suggests narcotic analgesics may avoid an NSAID side-effect in one class of patients).
59. See U.S. General Accounting Office, FDA Drug Review: Postapproval Risks 1976-1985, PEMD-90-15 (1990): at 25,101-05.
60. See U.S. General Accounting Office, FDA Premarket Approval: Process of Approving Ansaid as a Drug, HRD-92-85 (1992): at 3;
61. B.L. Strom & P. Tugwell, "Pharmacoepidemiology: Current Status, Prospects, and Problems," Annals of Internal Medicine, 113 (1990): 179-81, at 180;
62. see also Deficiencies in FDA's Regulation of the New Drug "Oraflex", H.R. Rep. No. 98-511 (1983): at 3-4 (noting liver toxicity and other serious reactions);
63. A.C. Rossi et al., "The Importance of Adverse Reaction Reporting by Physicians: Suprofen and the Flank Pain Syndrome," JAMA, 259 (1988): 1203-04.
64. See FDA's Regulation of Zomax, H.R. Rep. No. 98-584 (1983): at 7-8;
65. see also Nichols v. McNeilab, Inc., 850 F. Supp. 562, 564-65 (E.D. Mich. 1993) (holding that the manufacturer had a duty to inform the public directly of the withdrawal);
66. D. Ross-Degnan et al., "Examining Product Risk in Context: Market Withdrawal of Zomepirac as a Case Study," JAMA, 270 (1993): 1937-42;
67. cf. D.A. Kessler et al., "Approval of New Drugs in the United States," JAMA, 276 (1996): 1826-31, at 1831 ("[K]etorolac, a patenteral analgesic, has been retained on the market ... despite [serious] adverse effects ... [because they] were not deemed to outweigh ketorolac's benefits, which include an absence of the respiratory depression normally associated with narcotic analgesics, typically the alternative therapeutic choice.").
68. See id.
69. See J. Schwartz, "New Painkiller Taken Off Market After Deaths," Washington Post, June 23, 1998, at A2.
70. See R. Sharpe, "How a Drug Approved by the FDA Turned into a Lethal Failure," Wall Street Journal, Sept. 30, 1998, at A1.
71. See id.
72. See id.
73. The FDA alerted physicians that the drug was unsafe when used longer than the 10 days tested in the clinical trials. See id.;
74. FDA, Warning Label Changes for Pain Reliefer Duract, Talk Paper, No. T98-6 (Feb. 10, 1998), available at 〈http:// www.fda.gov/bbs/topics/ ANSWERS/ANS00849.html〉.
75. See Letter from Wyeth-Ayerst Laboratories to Health Care Professionals (Feb. 1998), available at 〈http://www.fda.gov/ medwatch/safety/1998/duract. htm〉.
76. See B.A. Noah, "Adverse Drug Reactions: Harnessing Experiential Data to Promote Patient Welfare," Catholic University Law Review, 49 (2000): 449-504, at 488-89.
77. See FDA, "Wyeth-Ayerst Laboratories Announces the Withdrawal of Duract from the Market," Talk Paper, No. T98-36 (June 22, 1998), available at 〈http://www.fda.gov/bbs/topics/ ANSWERS/ANS00879.html〉.
78. See United States v. Article of Drug Labeled "Decholin", 264 F. Supp. 473, 482 n.9 (E.D. Mich. 1967) (noting that the FDA would not limit aspirin to prescription use even though "at the root of a headache may lie anything from nervous tension to a malignant brain tumor").
79. See L. Noah, "Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy," American Journal of Law & Medicine,28 (2002): 361-408, at 395 & n. 178.
80. See Food, Drug & Cosmetic Act, ch. 675, §§ 502, 503, 52 Stat. 1040, 1050 (1938) (codified at 21 U.S.C. §§ 352(d), 353 (b)) (requiring prescriptions for all habit-forming drugs), amended by Durham-Humphrey Amendments, Pub. L. No. 215, ch. 578, § 1, 65 Stat. 648 (1951), amended by Drug Abuse Control Amendments of 1965, Pub. L. No. 89-74, § 4, 79 Stat. 226, amended by Controlled Substances Act, Pub. L. No. 91-513, title II(G), 84 Stat. 1242, 1281-82 (1970);
81. see also P.B. Hurt, "A Legal Framework for Future Decisions on Transferring Drugs from Prescription to Nonprescription Status," Food Drug Cosmetic Law Journal, 37 (1982): 427-40, at 428, 435, 440;
82. cf. 21 U.S.C. § 829(d) (2000) (allowing the DEA to recommend to the FDA prescription status for OTC drugs with an abuse potential).
83. See 21 C.F.R. pt. 330 (2002); see also Cutler v. Hayes, 818 F.2d 879, 883-85 (D.C. Cir. 1987) (describing the OTC drug review process);
84. P.R. Jones, Note, "Protecting the Consumer from Getting Burned: The FDA, the Administrative Process, and the Tentative Final Monograph on Over-the-Counter Sunscreens," American Journal of Law & Medicine, 20 (1994): 317-35.
85. See 37 Fed. Reg. 14,633 (1972);
86. see also 37 Fed. Reg. 26,456 (1972) (call for data on topical analgesics).
87. See 42 Fed. Reg. 35,346 (1977) (concluding, for instance, that a few ingredients used in then-marketed analgesics (e.g., phenacetin) were not generally recognized as safe and/or effective);
88. see also 44 Fed. Reg. 69,768 (1979) (panel report for external analgesics).
89. See 53 Fed. Reg. 46,204 (1988);
90. see also 48 Fed. Reg. 5,852 (1983) (TFM for external analgesics), amended, 51 Fed. Reg. 27,360 (1986).
91. 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.
92. See 55 Fed. Reg. 27,776, 27,784 (1990) (codified at 21 C.F.R. § 201.63(e)).
93. See 66 Fed. Reg. 61,555, 61,575 (2001) (semiannual unified regulatory agenda forecasting final action on this monograph by Dec. 2002). The most recent unified regulatory agenda does not provide any estimated date of finalization for this rule.
94. See 67 Fed. Reg. 33,058 (2002).
95. See 21 C.F.R. § 330.11 (2002); 65 Fed. Reg. 24,704, 24,704-05 (2000);
96. Farquhar v. FDA, 616 F. Supp. 190, 192 (D.D.C. 1985);
97. see also S.P. Mahinka & E. Bierman, "Direct-to-OTC Marketing of Drugs: Possible Approaches," Food & Drug Law Journal, 50 (1995): 49-63;
98. L.R. Rook, "Listening to Zantac: The Role of Non-Prescription Drugs in Health Care Reform and the Federal Tax System," Tennessee Law Review, 62 (1994): 107-39;
99. P. Temin, "Realized Benefits from Switching Drugs," Journal of Law & Economics, 35 (1992): 351-69.
100. See I. Molotsky, "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.
101. See 67 Fed. Reg. 54,139 (2002).
102. See G. Mays, "Pain-Killer Wars Can Be a Pain for Ailing Consumers," Chicago Tribune, Nov. 24,1995, at Bus. 1.
103. Cf. Bober v. Glaxo Wellcome PLC, 246 F.3d 934, 939-10, 942 (7th Cir. 2001).
104. See S.G. Boodman, "Painful Choices: Consumers Face a Baffling Wall of Choices -and a Surprising Number of Serious Risks-When They Seek Relief from Minor Pains and Illnesses at the Drug Store," Washington Post, Feb. 11, 2003, at Z1. Apart from the risks associated with the proper use of OTC products, they also may pose hazards of misuse. For example, responding to numerous instances of childhood poisoning from the accidental ingestion of aspirin and similar products, Congress enacted special child-proof packaging requirements.
105. See Poison Prevention Packaging Act of 1970, Pub. L. No. 91-601, 84 Stat. 1670 (codified as amended at 15 U.S.C. §§ 1471-1476 (2000)); 16 C.F.R. pt. 1700 (2002). In addition, after seven people in the Chicago area suffered cyanide poisoning in 1982 from ingesting tainted Extra-Strength Tylenol® capsules, the FDA swiftly imposed tamper-resistant packaging requirements for most OTC drugs.
106. See 47 Fed. Reg. 50,442, 50,449-50 (1982) (codified as amended at 21 C.F.R. § 211.132);
107. see also Federal Anti-Tampering Act, Pub. L. No. 98-127, 97 Stat. 831 (1983) (codified at 18 U.S.C. § 1365 (2000)). Although one occasionally hears complaints that such rules have made it difficult for elderly and arthritic consumers to open containers, these controls have reduced instances of dangerous misuse at relatively trivial additional cost to users.
108. See 50 Fed. Reg. 51,400, 51,401 (1985);
109. 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);
110. 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).
111. 21 C.F.R. § 201.314(h)(1) (2002).
112. 53 Fed. Reg. 21,633, 21,635 (1988).
113. 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);
114. 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);
115. C. Adams, "Makers of Rival Pain Relievers Trade Jabs on Safety," Wall Street Journal, Sept. 18, 2002, at B1.
116. See S.H. Roth, Editorial, "Nonsteroidal Anti-inflammatory Drugs: Gastropathy, Deaths, and Medical Practice," Annals of Internal Medicine, 109 (1988): 353-54;
117. C.M. Wilcox 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;
118. J. Foreman, "Painkillers Often Take Toll on Stomach," Boston Globe, July 8, 1996, at 25;
119. J. Weber & Z. Schiller, "Pain-killers 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.
120. See J.E. Edwards 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.
121. See N.I. Cherny, "Opioid Analgesics: Comparative Features and Prescribing Guidelines," Drugs, 51 (1996): 713-37;
122. A. Jacox et al., "New Clinical-Practice Guidelines for the Management of Pain in Patients with Cancer," N. Engl. J. Med., 330 (1994): 651-55, at 653 ("Of the many methods available to manage pain in cancer, drug therapy is the cornerstone because it entails relatively little risk, is usually inexpensive, and as a rule works quickly.");
123. M.H. Levy, "Pharmacologic Treatment of Cancer Pain," N. Engl. J. Med., 335 (1997): 1124-32;
124. H. McQuay, "Opioids in Pain Management," Lancet, 353 (1999): 2229-32;
125. C. Ripamonti & E.D. Dickerson, "Strategies for the Treatment of Cancer Pain in the New Millennium," Drugs, 61 (2001): 955-77;
126. P.C. Crowley, Comment, "No Pain, No Gain? The AHCPR's Attempt to Change Inefficient Health Care Practice of Withholding Medication from Patients in Pain," Journal of Contemporary Health Law & Policy, 10 (1994): 383-403, at 391-93.
127. See generally C. Stein, ed., Opioids in Pain Control: Basic and Clinical Aspects (Cambridge, England: Cambridge Univ. Press, 1999).
128. See J. Laurance, "Are We Really Born to Suffer?," Times of London, Jan. 27, 1997, at 18;
129. see also 21 C.F.R. § 882.5890 (2002) (FDA regulation classifying transcutaneous electrical nerve stimulation devices for pain relief);
130. M.I. Johnson et al., "An In-Depth Study of Long-Term Users of Transcutaneous Electrical Nerve Stimulation," Pain, 44 (1991): 221-29;
131. cf. R.A. Deyo et al., "A Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation (TENS) and Exercise for Chronic Low Back Pain," N. Engl. J. Med., 332 (1990): 1627-34 (finding the treatment ineffective);
132. E.A. Ghoname et al., "Percutaneous Electrical Nerve Stimulation for Low Back Pain: A Randomized Crossover Study," JAMA, 281 (1999): 818-23 (evaluating a method supplying deeper stimulation).
133. See Controlled Substances Act, Pub. L. No. 91-513, title II, 84 Stat. 1242 (1970) (codified as amended at 21 U.S.C. §§ 801-904 (2000)).
134. 21 U.S.C. § 812(b)(1).
135. Id. § 812(b)(2).
136. See id. § 812(b)(3)-(5).
137. See Uniform Controlled Substances Act of 1994;
138. see also R.L. Brown, "Uniform Controlled Substances Act of 1990," Campbell Law Review, 13 (1991): 365-74.
139. These examples come from the lists of substances appearing in each of the schedules. See 21 U.S.C. § 812; 21 C.F.R. pt. 1308 (2002). The brand-name versions of analgesic products come from the Physicians' Desk Reference, 56th ed. (Montvale, New Jersey: Medical Economics Co., 2002).
140. 21 U.S.C. § 801(1).
141. See Alliance for Cannabis Therapeutics (ACT) v. DEA, 930 F.2d 936, 938 (D.C. Cir. 1991);
142. see also L. Scott, "The Pleasure Principle: A Critical Examination of Federal Scheduling of Controlled Substances," Southwestern University Law Review, 29 (2000): 447-500, at 455 ("The purpose of the legislation is to legalize the possession and use of certain drugs for medical purposes, and to criminalize their possession and use for any other purposes.").
143. Congress did set out a number of factors to consider, but these relate primarily to the potential for abuse rather than what qualifies as currently accepted medical use: (1) [A substance's] actual or relative potential for abuse. (2) Scientific evidence of its pharmacological effect, if known. (3) The state of current scientific knowledge regarding the drug or other substance. (4) Its history and current pattern of abuse. (5) The scope, duration, and significance of abuse. (6) What, if any, risk there is to the public health. (7) Its psychic or physiological dependence liability. (8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
144. U.S.C. § 811 (c); see also National Organization for the Reform of Marijuana Laws (NORML) v. DEA, 559 F.2d 735, 747-48 (D.C. Cir. 1977) (suggesting that the potential for abuse rather than medical use distinguishes the schedules).
145. See 21 U.S.C. § 811(b) (directing HHS to consider the listed factors); 116 Cong. Rec. 33,300 (1970) (statement by Rep. Springer) (emphasizing "that purely enforcement responsibilities are placed with the Department of Justice while medical and scientific judgments necessary to drug control are left where they properly should lie and that is with the Department of Health, Education, and Welfare"); NORML, 559 F.2d at 745-47.
146. Pub. L. No. 95-633, § 101, 92 Stat. 3768 (1978) (codified as amended at 21 U.S.C. §801a(3)(C)) (emphasis added).
147. See 21 U.S.C. §§ 821-829.
148. See id. §§ 823(a), 826; 21 C.F.R. pt. 1303;
149. see also MD Pharm., Inc. v. DEA, 133 F.3d 8, 10-11, 16 (D.C. Cir. 1998) (rejecting methylphenidate manufacturer's challenge to the registration of a competitor);
150. Western Fher Lab. v. Levi, 529 F.2d 325, 330-32 (1st Cir. 1976) (affirming challenged production quotas for phenmetrazine);
151. L. Noah, "Sham Petitioning as a Threat to the Integrity of the Regulatory Process," North Carolina Law Review, 74 (1995): 1-73, at 9 n.24, 69 (discussing the DEAs effort to combat the delays that result when competitors routinely file objections to each other's manufacturer registration and production quota applications).
152. See 21 U.S.C. § 829(a); 21 C.F.R. §§ 1301.72(a), 1301.73, 1301.74(e), 1304.11(e)(3)(i), 1305.03, 1306.11(a), 1306.12;
153. United States v. Poulin, 926 F. Supp. 246, 249-55 (D. Mass. 1996) (concluding that a pharmacy had violated numerous requirements applicable to Schedule II drugs);
154. D.J. Pisano, "Controlled Substances and Pain Management: Regulatory Oversight, Formularies, and Cost Decisions," Journal of Law, Medicine & Ethics, 24 (1996): 310-16, at 311-12.
155. See 21 U.S.C. §§ 822-824; 21 C.F.R. § 1301.36;
156. see also Humphreys v. DEA, 96 F.3d 658 (3d Cir. 1996) (reversing the revocation of a physician's certificate of registration);
157. Kirk v. Mullen, 749 F.2d 297, 298 (6th Cir. 1984) (noting that the DEA processed more than half a million CSA registrations annually).
158. See 62 Fed. Reg. 6,164 (1997);
159. see also Conant v. McCaffrey, 2000 WL 1281174 (N.D. Cal. 2000) (invalidating one aspect of this policy as inconsistent with the CSA when read to take the First Amendment into account), aff'd, 309 F.3d 629 (9th Cir. 2002);
160. G.J. Annas, "Reefer Madness - The Federal Response to California's Medical-Marijuana Law," N. Engl. J. Med., 337 (1997): 435-39.
161. United States v. Oakland Cannabis Buyers' Co-operative, 532 U.S. 483 (2001). For some of the relevant academic commentary that predated the Court's decision,
162. see M.N. Cohen, "Breaking the Federal/State Impasse over Medical Marijuana: A Proposal," Hastings Women's Law Journal, 11 (2000): 59-74;
163. J.P. Kassirer, Editorial, "Federal Foolishness and Marijuana," N. Engl. J. Med., 336 (1997): 366-67;
164. A.J. LeVay, Note, "Urgent Compassion: Prosecutorial Discretion and the Medical Necessity Defense," Boston College Law Review, 41 (2000): 699-753;
165. E.R. Neusch, Comment, "Medical Marijuana's Fate in the Aftermath of the Supreme Court's New Commerce Clause Jurisprudence," University of Colorado Law Review, 72 (2001): 201-55.
166. See Cal. Health & Safety Code Ann. § 11362.5 (West Supp. 2002) (decriminalizing only the cultivation and possession for use based on a physician's recommendation);
167. People v. Mower, 49 P.3d 1067 (Cal. 2002).
168. See generally A.W Bock, Waiting to Inhale: The Politics of Medical Marijuana (Santa Ana: Seven Locks Press, 2000).
169. See Oakland Cannabis, 532 U.S. at 491-94.
170. See id. at 500-01 & n.2 (Stevens, J., concurring in judgment) (calling the majority's suggestion to the contrary dicta).
171. Id. at 493.
172. See id. at 492-93.
173. See H.R. Rep. No. 91-1444 (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4577-79;
174. NORML v. Ingersoll, 497 F.2d 654, 657 (D.C. Cir. 1974).
175. See 21 U.S.C. § 321(g)(1)(A) (2000);
176. see also State v. Wakeen, 57 N.W.2d 364, 369 (Wis. 1953) (noting that the pharmacy practice statutes in most states cross-reference the U.S.P.).
177. But cf. United States v. Article of Drug... Ova II, 414 F. Supp. 660, 665-66, 667-73 (D.N.J. 1975) (rejecting an FDA effort to assert its drug authority over a product simply by virtue of its inclusion in the U.S.P.), aff'd mem., 535 F.2d 1248 (3d Cir. 1976).
178. See E. Russo, "Cannabis for Migraine Treatment: The Once and Future Prescription? An Historical and Scientific Review," Pain, 76 (1998): 3-8.
179. See generally L. Grinspoon & J.B. Bakalar, Marihuana: The Forbidden Medicine, rev. ed. (New Haven: Yale Univ. Press, 1993);
180. M.L. Mathre, ed., Cannabis in Medical Practice: A Legal, Historical and Pharmacological Overview of the Therapeutic Use of Marijuana (Jefferson, North Carolina: McFarland & Co., 1997).
181. See I.D. Meng et al., "An Analgesia Circuit Activated by Cannabinoids," Nature, 395 (1998): 381-83;
182. E.M. Williamson &: F.J. Evans, "Cannabinoids in Clinical Practice," Drugs, 60 (2000): 1303-14;
183. R.L. Horz, "Chemicals in Pot Cut Severe Pain, Study Says," Los Angeles Times, October 27, 1997, at Al;
184. see also L. Grinspoon & J.B. Bakalar, "Marihuana as Medicine: A Plea for Reconsideration," JAMA, 273 (1995): 1875-76.
185. See J.E. Joy 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);
186. 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....").
187. 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);
188. M. Tiersky, 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).
189. See E. Goodman, Editorial, "The Uses of Pot," Washington Post, Aug. 4,2001, at A23.
190. Not Legalizing Marijuana for Medicinal Use, Pub. L. No. 105-277, Div. F, 112 Stat. 2681-760, 2681-761 (1998).
191. See A.S. Trebach, The Heroin Solution (New Haven: Yale Univ. Press, 1982): at 59-84;
192. A. Mondzac, "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;
193. E.L. Shapiro, "The Right to Privacy and Heroin Use for Painkilling Purposes by the Terminally Ill Cancer Patient," Arizona Law Review, 21 (1979): 41-59, at 43-48.
194. See T. Bennett, "The British Experience with Heroin Regulation," Law & Contemporary Problems, 51 (Winter 1988): 299-314.
195. 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);
196. see also L. Noah & R.A. Merrill, "Starting from Scratch?: Reinventing the Food Additive Approval Process," Boston University Law Review, 78 (1998): 329-443, at 354-55;
197. R.G. Pinco, "Implications of PDA's Proposal to Include Foreign Marketing Experience in the Over-the-Counter Drug Review Process," Food & Drug Law Journal, 53 (1998): 105-22.
198. See S.M. Stoll, 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;
199. see also id. at 179 ("Clearly, the United States maintains a model of drug control more suited to law enforcement than to medical concerns.");
200. P.W Fitzgerald, Comment, "Members of Congress as Medical Experts: Heroin and the Compassionate Pain Relief Act," St. Louis University Public Law Review, 6 (1987): 371-90.
201. 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.
202. See Pub. L. No. 98-329, 98 Star. 280 (1984).
203. 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);
204. United States v. Alexander, 673 F.2d 287 (9th Cir. 1982).
205. See 21 U.S.C. § 811(b) (2000).
206. 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");
207. 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).
208. H.R. Rep. No. 91-1444 (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4589.
209. See D.F. Musto, The American Disease: Origins of Narcotic Control, 3d ed. (New York: Oxford Univ. Press, 1999);
210. R.E. Barnett, Book Review, "Bad Trip: Drug Prohibition and the Weakness of Public Policy," Yale Law Journal, 103 (1994): 2593-630
211. (reviewing S.B. Duke & A.C. Gross, America's Longest War: Rethinking Our Tragic Crusade Against Drugs (New York: G.P. Putnam's Sons, 1993));
212. E.G. Luna, "Our Vietnam: The Prohibition Apocalypse," DePaul Law Review, 46 (1997): 483-568;
213. E.A. Nadelmann, "Drug Prohibition in the United States: Costs, Consequences, and Alternatives," Science, 245 (1989): 939-47;
214. M.D. Newcomb, "Substance Abuse and Control in the United States: Ethical and Legal Issues," Social Science & Medicine, 35 (1992): 471-79.
215. See L. Noah, "Divining Regulatory Intent: The Place for a 'Legislative History' of Agency Rules," Hastings Law Journal, 51 (2000): 255-323, at 301;
216. S. Shapiro & T. McGarity, "Reorienting OSHA: Regulatory Alternatives and Legislative Reform," Yale Journal on Regulation, 6 (1989): 1-63, at 57-62.
217. See Inspector General Act, Pub. L. No. 95-452, 92 Stat. 1101 (1978) (codified as amended at 5 U.S.C. app. II (2000));
218. M.J. Gates & M.F. Knowles, "The Inspector General Act in the Federal Government: A New Approach to Accountability," Alabama Law Review, 36 (1985): 473-513;
219. see also L. Noah, "Scientific 'Republicanism': Expert Peer Review and the Quest for Regulatory Deliberation," Emory Law Journal, 49 (2000): 1033-83.
220. See 49 U.S.C. § 1131 (2000);
221. M. Wald, "Two Positions on Safety," New York Times, Aug. 30, 1998, at A16;
222. "The FAA Should Inspect Itself," Washington Post, May 23, 1996, at A20;
223. see also A.J. Wood 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).
224. See, e.g., R.A. Merrill &: J.K. Francer, "Organizing Federal Food Safety Regulation," Selon Hall Law Review, 31 (2000): 61-173;
225. M. Allen & J. Mintz, "Homeland Department May Take a Year to Take Shape," Washington Post, Nov. 21, 2002, at A8.
226. See J. Mashaw et al., Administrative Law: The American Public Law System, 4th ed. (St. Paul: West Group, 1998): at 21-28, 174-75;
227. E. Meidinger, "Regulatory Culture: A Theoretical Outline," Law & Policy, 9 (1987): 355-86, at 360, 372-74.
228. 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),
229. 44 Fed. Reg. 36,123 (1979), remanded, NORML v. DEA, No. 79-1660 (D.C. Cir. Oct. 16, 1980), hearing announced,
230. 51 Fed. Reg. 22,946 (1986), petition denied,
231. 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).
232. See United States v. Greene, 892 F.2d 453, 455-56 (6th Cir. 1989);
233. Pearson v. McCaffrey, 139 F. Supp. 2d 113, 120-23 (D.D.C. 2001);
234. NORML v. Bell, 488 F. Supp. 123, 132-43 (D.D.C. 1980) (three-judge court);
235. 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");
236. R.A. Burt, "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.
237. See Andrews v. Ballard, 498 F. Supp. 1038,1047-57 (S.D. Tex. 1980) (invalidating a state's licensing restriction).
238. 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.
239. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000);
240. L. Noah & B.A. Noah, "Nicotine Withdrawal: Assessing the FDA's Effort to Regulate Tobacco Products," Alabama Law Review, 48 (1996): 1-63.
241. See 51 Fed. Reg. 17,476, 17,478 (1986) (synthetic dronabinol in sesame oil encapsulated in soft gelatin capsules);
242. see also 47 Fed. Reg. 10,080 (1982) (announcing the FDA's proposed rescheduling recommendation pending approval of the NDA);
243. R.M. Cooper, "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).
244. See 64 Fed. Reg. 35,928, 35,930 (1999).
245. See 57 Fed. Reg. 10,499, 10,507-08 (1992) (adding that, "[b]y any modern scientific standard, marijuana is no medicine");
246. 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.
247. 54 Fed. Reg. 53,767, 53,784 (1989). On the pitfalls of relying on the biomedical literature in this fashion,
248. see L. Noah, "Sanctifying Scientific Peer Review: Publication as a Proxy for Regulatory Decisionmaking," University of Pittsburgh Law Review, 59 (1998): 677-717.
249. See ACT v. DEA, 15 F.3d 1131, 1135-37 (D.C. Cir. 1994).
250. 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.
251. 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).
252. See P.J. Hilts, "After Two-Decade Halt, Marijuana Research Is Set," New York Times, Dec. 15, 2001, at A16;
253. see also M. Robichaux, "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.").
254. See 21 U.S.C. § 812(b) (2000).
255. See 57 Fed. Reg. at 10,504-07 (also requiring that the drug's chemistry be known and reproducible);
256. 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.").
257. 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),
258. Fed. Reg. at 53,783-84, which the reviewing court rejected as unworkable,
259. see ACT v. DEA, 930 F.2d at 940.
260. See 57 Fed. Reg. at 10,503-04.
261. 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);
262. United States v. Seven Cardboard Cases... "Esgic with Codeine Capsules", 716 F. Supp. 1221, 1224-25 (E.D. Mo. 1989).
263. 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);
264. NORML v. DEA, 559 F.2d 735, 748-50 & n.65 (D.C. Cir. 1977);
265. 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.
266. See United States v. Carlson, 87 F.3d 440, 444-45 (11th Cir. 1996);
267. cf. R. Weiss, "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).
268. See D.D. Rohde, "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);
269. see also Pub. L. No. 106-172, § 3(a)(1), 114 Stat. 7, 8 (2000);
270. R. Rubin, "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);
271. A. Zitner, "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).
272. 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.
273. See United States v. Lafoon, 978 F.2d 1183, 1184-85 (10th Cir. 1992).
274. 21 C.F.R. §1306.04(a) (2002);
275. see also United States v. Moore, 423 U.S. 122, 141-42 (1975) ("[Provisions throughout the Act reflect the intent of Congress to confine authorized medical practice within acceptable limits.");
276. id. at 126-27, 139-45 (allowing felony conviction of physician who prescribed methadone in an unorthodox detoxification program that more closely resembled the activities of a "pusher");
277. United States v. Betancourt, 734 F.2d 750, 757 (11th Cir. 1984) ("[T]he jury needed medical testimony as to what the drug is, how it is properly used, how it can be abused and the medical profession's view of the drug.");
278. Noell v. Bensinger, 586 F.2d 554, 557-58 (5th Cir. 1978) (upholding the revocation of a physician's certificate of registration notwithstanding the fact that the only expert who testified had stated that the prescription of amphetamines to counteract fatigue comported with accepted standards of medical practice);
279. United States v. Green, 511 F.2d 1062, 1069-70 (7th Cir. 1975) (upholding the DEA's regulation even though the statute did not explicitly require that a controlled substance only be prescribed for a legitimate medical use);
280. D.J. Behr, "Prescription Drug Control Under the Federal Controlled Substances Act: A Web of Administrative, Civil, and Criminal Law Controls," Washington University Journal of Urban & Contemporary Law, 45 (1994): 41-119, at 61-65, 109, 112-13;
281. Annotation, "Federal Criminal Liability of Licensed Physician for Unlawfully Prescribing or Dispensing 'Controlled Substance' or Drug in Violation of the Controlled Substances Act," 33 A.L.R. Fed. 220 (1977 & Supp. 2002).
282. See D.B. Brushwood & J.J. Carlson, "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");
283. 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.");
284. see also United States v. Leal, 75 F.3d 219, 223 (6th Cir. 1996) (upholding conviction of pharmacist);
285. 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.").
286. 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.");
287. 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....").
288. 48 Fed. Reg. 26,720, 26,733 (1983);
289. see also 21 C.F.R. § 312.2(d) (explaining that the PDA's investigational new drug requirements "do not apply to the use in the practice of medicine for an unlabeled indication of [an approved] new drug");
290. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350-51 & n.5 (2001);
291. FTC v. Simeon Mgmt. Corp., 391 F. Supp. 697, 706-07 (N.D. Cal. 1975), aff'd, 532 F.2d 708, 717 (9th Cir. 1976) ("FDA has specifically recognized the legality of using drugs for purposes other than those for which they have been found safe and effective.");
292. J.D. Archer, Editorial, "The FDA Does Not Approve Uses of Drugs," JAMA, 252 (1984): 1054-55.
293. See L. Noah, "Constraints on the Off-Label Uses of Prescription Drugs," Journal of Products & Toxics Liability, 16 (1994): 139-65, at 139-44.
294. See J.R. Cooper et al., "Prescription Drug Diversion Control and Medical Practice," JAMA, 268 (1992): 1306-10, at 1308-09.
295. 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.
296. See 62 Fed. Reg. 6,164 (1997).
297. See B.S. Galer et al., "Individual Variability in the Response to Different Opioids: Report of Five Cases," Pain, 49 (1992): 87-91;
298. R.K. Portenoy, "Opioid Therapy for Chronic Nonmalignant Pain: Clinicians' Perspective," Journal of Law, Medicine & Ethics, 24 (1996): 296-309, at 298-99;
299. see also C. Ripamonti et al., "An Update on the Clinical Use of Methadone for Cancer Pain," Pain, 70 (1997): 109-15.
300. See S.H. Sindrup & K. Brøsen, "The Pharmacogenetics of Codeine Hypoalgesia," Pharmacogenetics, 5 (1995): 335-46, at 343;
301. see also S. Olivier, "Tailor-Made Drugs?," Tunes of London, Feb. 12,2002 (describing the impact of hormonal differences on the effectiveness of analgesics).
302. See generally L. Noah, "The Coming Pharmacogenomics Revolution: Tailoring Drugs to Fit Patients' Genetic Profiles," Jurimetrics Journal, 43 (2002): 1-28.
303. 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.");
304. see also D.E. Joranson & A.M. Gilson, "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).
305. 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");
306. see also R. Steinbrook, "Physician-Assisted Suicide in Oregon: An Uncertain Future," N. Engl. J. Med., 346 (2002): 460-64;
307. J. Cordaro, Note, "Who Defers to Whom? The Attorney General Targets Oregon's Death with Dignity Act," Fordham Law Review, 70 (2002): 2477-514;
308. A. Trafford, "Don't Dismiss This as Physician Paranoia," Washington Post, Mar. 12, 2002, at Z1.
309. 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);
310. see also L. Noah, Letter, "Attorney General's Intrusion into Clinical Practice," N. Engl. J. Med., 346 (2002): 1918.
311. See Oregon v. Ashcroft, 192 F. Supp. 2d 1077 (D. Or. 2002), appeal pending, No. 02-35587 (9th Cir. 2003).
312. 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);
313. see also id. § 811(g)(1) (calling for the descheduling of any nonnarcotic substance used in an FDA-approved OTC drug product);
314. United States v. Martinez, 950 F.2d 222, 223-24 (5th Cir. 1991) (construing this provision);
315. United States v. Caperell, 938 F.2d 975, 978-79 (9th Cir. 1991).
316. For instance, alternative modes of delivery for other pharmaceutical products may reflect attempts to reduce pain associated with their administration. See T. Chea, "MedImmune'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.
317. See K.H. Mosser, "Transdermal Fentanyl in Cancer Pain," American Family Physician, 45 (1992): 2289-94;
318. see also W. Jeal & P. Benfield, "Transdermal Fentanyl: A Review of Its Pharmacological Properties and Therapeutic Efficacy in Pain Control," Drugs, 53 (1997): 109-38;
319. D.M. Neighbors 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.
320. See "Deaths Are Followed by Pain Patch Restrictions," Chicago Sun-Times, Feb. 6,1994, at 54 (reporting that the manufacturer strengthened warnings after several deaths were associated with misuse of the Duragesic patch);
321. see also Erony v. Alza Corp., 913 F. Supp. 195 (S.D.N.Y. 1995) (allowing an inadequate warning claim to proceed on behalf of a teenager who died after sucking on his father's used Duragesic patches).
322. See D. Brown & J. Schwartz, "The Good and Bad Sides of a Narcotic Lollipop," Washington Post, Jan. 31, 1994, at A3;
323. P.J. Hilts, "U.S. Urged to Bar Narcotic Lollipop for Children," New York Times, Jan. 26, 1994, at A10 (describing the DEA's objections);
324. see also J. Brody, "The Forgotten Child in Treating Pain Is the Child," New York Times, Oct. 25,1995, at C11 (noting "drug companies' reluctance to develop pediatric analgesics," and explaining that doctors have resisted using the fentanyl lollipop with children).
325. See S.G. Boodman, "Narcotic Lollipop Gets Approval by FDA Panel," Washington Post, Sept. 23, 1997, at Z5;
326. see also R. Payne et al., "Long-Term Safety of Oral Transmucosal Fentanyl Citrate for Breakthrough Cancer Pain," Journal of Pain & Symptom Management, 22 (2001): 575-83.
327. See Hutchinson statement, supra note 127, at 15-17;
328. A. Kumar, "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.
329. See K. Fackelmann, "Health Campaign Takes Aim at Prescription Drug Abuse," USA Today, Apr. 10, 2001, at D7;
330. see also B. Vastag, "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.").
331. See N. Aoki, "Abusing Pain Pills: Is Maker to Blame?," Boston Globe, July 4, 2001, at D1;
332. 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.");
333. see also C. Adams, "Painkiller's Sales Far Exceeded Maker's Plans," Wall Street Journal, May 16, 2002, at D2.
334. See E Tough, "The Alchemy of OxyContin," New York Times Magazine, July 29, 2001, at 32;
335. cf. Crocker v. Winthrop Lab., 514 S.W.2d 429 (Tex. 1974) (allowing a tort claim to proceed against the seller of the prescription analgesic Talwin® (pentazocine) for misrepresenting it as nonaddictive).
336. See B. Meier, "Overdoses of Painkiller Are Linked to 282 Deaths," New York Times, Oct. 28, 2001, at A20;
337. see also D.E. Hoffmann & A.J. Tarzian, "Achieving the Right Balance in Oversight of Physician Opioid Prescribing for Pain: The Role of State Medical Boards," Journal of Law, Medicine & Ethics, 31 (2003): 21-40.
338. See E. Mehren, "Hooks of 'Hillbilly Heroin': Abuse of Prescription Painkiller OxyContin Ravages Poor Areas in the East," Los Angeles Times, Oct. 4, 2001, at A1.
339. See G. Singh, "Recent Considerations in Nonsteroidal Anti-Inflammatory Drug Gastropathy," American Journal of Medicine, 105, suppl. IB (1998): 31-38, at 33 (estimating 16,500 deaths annually just among arthritis patients);
340. see also G.C. Curhan et al., "Frequency of Analgesic Use and Risk of Hypertension in Younger Women," Archives of Internal Medicine, 162 (2002): 2204-08.
341. See R. Rubin, "Abuse-Resistant OxyContin Planned," USA Today, Aug. 9, 2001, at 2A.
342. See L. Neergaard, "Abuse-Resistant OxyContin Hits Snag," Associated Press Newswire, June 18, 2002.
343. See J. White, "Va. Class-Action Suit Filed Against OxyContin Firm," Washington Post, June 19, 2001, at A6;
344. 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);
345. Salisbury v. Purdue Pharma, L.P., 166 F. Supp. 2d 546, 548 (E.D. Ky. 2001);
346. McCallister v. Purdue Phanna, L.P., 164 F. Supp. 2d 783, 787-88, 791-92 (S.D. W. Va. 2001);
347. R.C. Ausness, "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.
348. See J. White, "OxyContin Abuse Is Increasing, DEA Says," Washington Post, Dec. 12,2001, at A10;
349. see also C. Adams, "FDA Asks Maker of OxyContin to Pull 'Misleading' Print Ads," Wall Street Journal, Jan. 23, 2003, at D3;
350. J. Carter, "Senate Committee Examines Marketing Practices of OxyContin Manufacturer," Associated Press Newswire, Feb. 12, 2002.
351. See D.B. Brushwood & F.H. Fern, "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;
352. J.H. Krause, "Accutane: Has Drug Regulation in the United States Reached Its Limits?," Journal of Law & Health, 6 (1991): 1-29, at 18-23;
353. M.A. Hurwitz, Note, "Bundling Patented Drugs and Medical Services: An Antitrust Analysis," Columbia Law Review, 91 (1991): 1188-220, at 1192-95.
354. See American Pharm. Ass'n v. Weinberger, 377 F. Supp. 824, 831 (D.D.C. 1974) (invalidating the PDA'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);
355. L. Noah, "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;
356. see also M. Kaufman, "FDA Reapproves Bowel Drug After Pulling It for Safety," Washington Post, June 8, 2002, at A4;
357. F.L. Kritz, "FDA to Weigh New Controls on Problematic Drugs," Washington Post, Apr. 16, 2002, at Z1.
358. Methadone represents an exception. See S.P. Molinari 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.").
359. See L. Noah, "Administrative Arm-Twisting in the Shadow of Congressional Delegations of Authority," Wisconsin Law Review (1997): 873-941, at 881-82.
360. See T. Pasko & B. Seidman, Physician Characteristics and Distribution in the US (Chicago: AMA Press, 2002): at 15,18;
361. 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).
362. See C.S. Cleeland, 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");
363. C. Gillespie, "Getting OxyContin Can Be an Ordeal for Those Who Need It," Los Angeles Times, Oct. 14, 2001, at A26;
364. P. Recer, "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).
365. See L. Marsa, "OxyContin Abuse May Curb Progress in Pain Field," Los Angeles Times, Aug. 13, 2001, at S1;
366. "Supermarket Chain Pulls Oxycontin," Associated Press Newswire, Apr. 16, 2002.
367. See J.A. Henderson, Jr., & A.D. Twerski, "Drug Designs Are Different," Yale Law Journal, 111 (2001): 151-81, at 168-72; L. Noah, "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.
368. See EL. Kritz, "Still Irritable, Still Waiting: After Return to Market, Lotronex Can Be Hard to Get," Washington Post, Feb. 11, 2003, at Z1.
369. See J. White, "More Warnings About OxyContin," Washington Post, July 26, 2001, at B2.
370. See 66 Fed. Reg. 38,713, 38,714 (2001).
371. See S. Satel, Op-Ed, "Keeping OxyContin out of the Wrong Hands," Boston Globe, Aug. 11, 2001, at A15;
372. see also D.H. Kreling 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.
373. See M.T. Reidy & M.H. Brown, "Suit Targets State Firm That Makes OxyContin," Hartford Courant, June 13, 2001, at A6.
374. See "OxyContin Maker Calls Plaintiffs' Allegations Baseless, Pledges to Ensure Supply for Patients," Product Safety & Liability Reporter, 29 (2001): 666-68, at 667.
375. See B. Meier, "U.S. Asks Painkiller Maker to Help Curb Wide Abuse," New York Times, May 1, 2001, at A12. 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).
376. 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).
377. See J. White, "Shipment of Potent Pain Pills Suspended: Company Interrupts Sales of Strongest Dosage of OxyContin Because of Abuse," Washington Post, May 12, 2001, at A9.
378. See R.L. DuPont & C.M. DuPont, "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.");
379. D.A. Kessler, "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.");
380. 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).
381. See D.R. Wesson & D.E. Smith, "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.");
382. B.B. Wilford 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....");
383. 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").
384. See J. White, "DEA Backs Medical Use of OxyContin," Washington Post, Oct. 24, 2001, at A26.
385. See J.A. Linder & R.S. Stafford, "Antibiotic Treatment of Adults with Sore Throat by Community Primary Care Physicians: A National Survey, 1989-1999," JAMA, 286 (2001): 1181-86;
386. L.F. McCaig & J.M. Hughes, "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.
387. See L.F. McCaig et al., "Trends in Antimicrobial Prescribing Rates for Children and Adolescents," JAMA, 287 (2002): 3096-102.
388. See S.B. Levy, The Antibiotic Paradox: How Miracle Drugs Are Destroying the Miracle (New York: Plenum Press, 1992): at 209-10;
389. L. Neergaard, "U.S. Acting to Stem Misuse and Prolong Life of Antibiotics," Philadelphia Inquirer, June 11, 2002, at A10;
390. A. Zuger, "The Other' Drug Problem: Forgetting to Take Them," New York Times, June 2, 1998, at F1.
391. 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 L. Noah, "NAFTA's Impact on the Trade in Pharmaceuticals," Houston Law Review, 33 (1997): 1293-326, at 1307-09, 1311-14.
392. See J. Gillis &: C. Connolly, "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);
393. see also U.S. Office of Technology Assessment, Impacts of Antibiotic-Resistant Bacteria, OTA-H-629 (Washington, D.C.: Government Printing Office, 1995);
394. M.L. Cohen, "Epidemiology of Drug Resistance: Implications for a Post-Antimicrobial Era," Science, 257 (1992): 1050-55.
395. See S.B. Levy, "The Challenge of Antibiotic Resistance," Scientific American, 278 (Mar. 1998): 46-53, at 52;
396. H.C. Neu, "The Crisis in Antibiotic Resistance," Science, 257 (1992): 1064-73, at 1064, 1072. Until recently, vancomycin represented the last line of defense, but resistant strains have emerged. In 2000, the FDA approved Zyvox® (linezolid), the first of a new class of antibiotics called oxazolidinones.
397. See T. Hayden, "Infectious Arms Race," U.S. News & World Report, Dec. 17, 2001, at 50.
398. See 65 Fed. Reg. 81,082, 81,095 (2000) (proposing revisions in the content of prescription drug labeling to reduce the tendency to overprescribe antibiotics);
399. 65 Fed. Reg. 56,511, 56,518 (2000) (proposing a best practices statement in the labeling of antibiotics to remind physicians against overprescribing).
400. See S.B. Markow, 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).
401. 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?").
402. See L. Noah, "Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community," Arizona Law Review, 44 (2002): 373-466, at 438-42;
403. see also T.J. Moore 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.").
404. See R. Gonzales et al., "Principles of Appropriate Antibiotic Use for Treatment of Acute Respiratory Tract Infections in Adults: Background, Specific Aims, and Methods," Annals of Internal Medicine, 134 (2001): 479-86, at 481-82 (introducing a series of CDC guidelines calling for restraint in prescribing antibiotics for adults);
405. see also T. Brewer and G.A. Colditz, "Postmarketing Surveillance and Adverse Drug Reactions: Current Perspectives and Future Needs," JAMA, 281 (1999): 824-29, at 826 (describing the CDC's vaccine adverse event surveillance efforts).
406. See generally E.W. Etheridge, Sentinel for Health: A History of the Centers for Disease Control (Berkeley: Univ. of California Press, 1992);
407. L.O. Gostin, Public Health Law: Power, Duty, Restraint (Berkeley: Univ. of California Press, 2000);
408. L. Noah, "Triage in the Nation's Medicine Cabinet: The Puzzling Scarcity of Vaccines and Other Drugs," South Carolina Law Review, 54 (forthcoming 2003).
409. See Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002) (invalidating a restriction on advertising by pharmacists who compound drug products);
410. L. Noah, "What's Wrong with 'Constitutionalizing Food and Drug Law,'" Tulane Law Review, 75 (2000): 137-48 (discussing litigation challenging the PDA's restrictions on indirect industry efforts to promote off-label drug uses).
411. 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.");
412. see also D. Brushwood, "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.
413. See M. Petersen & B. Meier, "Few States Track Prescriptions as Way to Prevent Overdoses," New York Times, Dec. 21, 2001, at A1.
414. See J. Avorn & S.B. Soumerai, "Improving Drug-Therapy Decisions Through Educational Outreach: A Randomized Controlled Trial of Academically Based 'Detailing,'" N. Engl. J. Med., 308 (1983): 1457-63;
415. M.D. Cabana et al, "Why Don't Physicians Follow Clinical Practice Guidelines? A Framework for Improvement," JAMA, 282 (1999): 1458-65;
416. R.L. Kane & J. Garrard, Editorial, "Changing Physician Prescribing Practices: Regulation vs. Education," JAMA, 271(1994): 393-94;
417. P.R. Manning et al., "Changing Prescribing Practices Through Individual Continuing Education," JAMA, 256 (1986): 230-32;
418. S.B. Soumerai et al., "Improving Drug Prescribing in Primary Care: A Critical Analysis of the Experimental Literature," Milbank Quarterly, 67 (1989): 268-317;
419. S.B. Soumerai & J. Avorn, "Principles of Educational Outreach ('Academic Detailing') to Improve Clinical Decision Making" JAMA, 263 (1990): 549-56.