1 Paul Duggan, 1,000 Swarm FDA's Rockville Office to Demand Approval of AIDS Drugs, Wash. Post (Oct. 12, 1988).

2 CDC, CDC Fact Sheet: Estimates of HIV Infections in the United States, 2 (Aug. 2008), http://www.cdc.gov/nchhstp/newsroom/docs/fact-sheet-on-hiv-estimates.pdf [https://perma.cc/64R4-L8UA].

3 See SuchIsLifeVideos, ACT UP & ACT NOW Seize Control of the FDA, YouTube (June 18, 2014).

4 Id. at 11:21–30 (“History will recall, Reagan and Bush did nothing at all!”).

5 Daniel Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA 436–37 (2010)

6 Id. 437–38.

7 Investigational New Drug, Antibiotic, and Biological Drug Product Regulations; Treatment Use and Sale, 52 Fed. Reg. 19,466 (May 22, 1987). See infra Section III.

8 Philip M. Boffey, New Initiative to Speed AIDS Drug Is Assailed, N.Y. Times (July 5, 1988).

9 William C. Buhles, Compassionate Use: A Story of Ethics and Science in the Development of a New Drug, 54 Persp. Biol. & Med. 304, 310–11 (2011).

10 In July 1988, FDA had approved one out of four treatment IND requests for AIDS-related drugs and four out of eight for other drugs. Boffey, supra note 8.

11 The details of the demonstration related below are drawn from various sources, including video footage of the event collated by SuchIsLife Videos, https://www.youtube.com/watch?v=s70aCOflRgY; the documentary How to Survive a Plague; interviews in the AUOHP, http://www.actuporalhistory.org/interviews/; Paul Duggan, 1,000 Swarm FDA's Rockville Office to Demand Approval of AIDS Drugs, Washington Post, October 12, 1988, at 1; 176 Arrested at FDA AIDS Drug Protest, Many Employees Don't Go to Work, Health Daily, October 12, 1988, at 2–4; FDA Resumes Business After AIDS Demonstration, Health Daily, October 17, 1988, at 7.

12 See “How to Survive a Plague”: As ACT UP Turns 25, New Film Chronicles History of AIDS Activism in U.S., Democracy Now (Mar. 23, 2012), http://www.democracynow.org/2012/3/23/how_to_survive_a_plague_as [https://perma.cc/47L4-8785].

13 See id.

14 SuchisLifeVideos, supra note 3, at 12:35–48.

15 Id.

16 Id.

17 Id.

18 See id. at 21:00.

19 Id. at 0:57–1:15.

20 Transcript of interview with Michael Nesline, ACT UP Oral History Project, The New York Lesbian & Gay Experimental Film Festival, Inc. (Mar. 24, 2003) http://www.actuporalhistory.org/interview/images/nesline.pdf [https://perma.cc/9MFS-VHE2].

21 SuchisLifeVideos, supra note 3, at 09:19–25.

22 Duggan, supra note 1.

23 Id.

24 FDA Resumes Business After AIDS Drug Demonstration, Health Daily (Oct. 17, 1988) at 8.

25 Id.

26 Duggan, supra note 1.

27 Transcript of interview with Jay Blotcher, ACT UP Oral History Project, The New York Lesbian & Gay Experimental Film Festival, Inc. (Apr. 24, 2004) http://www.actuporalhistory.org/interview/images/blotcher.pdf [https://perma.cc/8KH6-Z84B].

28 Interview with Michael Nesline, supra note 20, at 43.

29 Duggan, supra note 1 (“[A]n estimated 550 [employees] stayed away, a spokesman said.”).

30 21 U.S.C. §§ 301–399f (2015).

31 William, N. Eskridge Jr. & John, Ferejohn, Super-Statutes, 50 Duke L.J. 1215 (2001)Google Scholar; William N. Eskridge, Jr. & John Ferejohn, A Republic of Statutes: The New American Constitution (2010); cf. 3 Bruce Ackerman, We the People: The Civil Rights Revolution 9 (2014) (emphasizing the constitutional character of the seminal civil rights statutes of the 1960s).

32 Eskridge and Ferejohn identify both the Pure Food and Drugs Act and the FDCA as “super-statutes.” Eskridge & Ferejohn, supra note 31, at 1226, 1257–58.

33 Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, Food and Drug Law: Cases and Materials 11 (4th ed. 2014).

34 In 2009, tobacco products were added to this list. Family Smoking Prevention and Tobacco Control Act of 2009, Pub. L. No. 111-31, 123 Stat. 1776–1858 (2009) (current version at 21 U.S.C. §§ 387–387t).

35 Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780–96 (1962); Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539–83 (1976). In addition, the Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (1958), and the Color Additive Amendment of 1960, Pub. L. No. 86-618, 74 Stat. 397 (1960), established FDA premarket approval regimes requiring manufacturers to demonstrate safety (but not effectiveness) prior to sale.

36 See generally Carpenter, supra note 5.

37 See infra pp. 699-700.

38 See infra pp. 734-36.

39 Lani, Guinier & Gerald, Torres, Changing the Wind: Notes Toward a Demosprudence of Law and Social Movements, 123 Yale L.J. 2740, 2749 (2014)Google Scholar. For other examples of the growing literature on the interaction between social movements and law, see Michael McCann, Law and Social Movements, in The Blackwell Companion to Law and Society 506–22 (Austin Sarat ed., 2004); Steven A. Boutcher, Mobilizing in the Shadow of the Law: Lesbian and Gay Rights in the Aftermath of Bowers v. Hardwick, 31 Res. Soc. Movements Conflicts & Change 175 (2011); Tomiko, Brown-Nagin, Elites, Social Movements, and the Law: The Case of Affirmative Action, 105 Colum. L. Rev. 1436 (2005)Google Scholar; Susan, D. Carle, A Social Movement History of Title VII Disparate Impact Analysis, 63 Fla. L. Rev. 251 (2011)Google Scholar; Michael, C. Dorf, Identity Politics and the Second Amendment, 73 Fordham L. Rev. 549 (2004)Google Scholar; William, N. Eskridge Jr., Channeling: Identity-Based Social Movements and Public Law, 150 U. Pa. L. Rev. 419 (2001)Google Scholar; Edward, L. Rubin, Passing Through the Door: Social Movement Literature and Legal Scholarship, 150 U. Pa. L. Rev. 1 (2001)Google Scholar; Reva, B. Siegel, Constitutional Culture, Social Movement Conflict and Constitutional Change: The Case of the de facto ERA - 2005–06 Brennan Center Symposium Lecture, 94 Cal. L. Rev. 1323 (2006)Google Scholar.

40 Guinier & Torres, supra note 39, at 2749–56.

41 Eskridge & Ferejohn, supra note 31, at 3; For an example of this type of scholarship, see Jack, M. Balkin & Reva, B. Siegel, Principles, Practices, and Social Movements, 154 U. Pa. L. Rev. 927, 950 (2005)Google Scholar.

42 See, e.g., Eskridge & Ferejohn, supra note 31; Eskridge, supra note 39; Gillian, E. Metzger, Administrative Constitutionalism, 91 Tex. L. Rev. 1897 (2013)Google Scholar; Vicki, Schultz, Taking Sex Discrimination Seriously, 91 Denver U. L. Rev. 995 (2014)Google Scholar.

43 See generally Metzger, supra note 42.

44 See, e.g., Ruth, Landridge, When Do Challengers Succeed? Nongovernmental Actors, Administrative Agencies, and Legal Change: Shifting Rules for Oregon's Private Forests, 36 L. & Soc. Inquiry 662 (2011)Google Scholar; Schultz, supra note 42.

45 5 U.S.C. § 553(c) (2015).

46 Schultz, supra note 42, at 1025–26.

47 See, e.g., Cary, Coglianese, Social Movements, Law, and Society: The Institutionalization of the Environmental Movement, 150 U. Pa. L. Rev. 118 (2001)Google Scholar; Landridge, supra note 44.

48 See, e.g., Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (1996) [hereinafter Epstein 1996]; Steven, Epstein, The Construction of Lay Expertise: AIDS Activism and the Forging of Credibility in the Reform of Clinical Trials, 20 Sci. Tech. & Hum. Values 408 (1995)Google Scholar [hereinafter Epstein 1995]; David, J. Hess, Medical Modernisation, Scientific Research Fields and the Epistemic Politics of Health Social Movements, 26 Soc. Health Illness 695 (2004)Google Scholar.

49 Schultz emphasizes the importance of studying intra-movement divisions. Schultz, supra note 42.

50 Lewis A. Grossman, FDA and the Rise of the Empowered Consumer, 66 Admin. L. Rev. 627, 646–51, 666–68 (2014) [hereinafter Grossman 2014]; Lewis A. Grossman, FDA and the Rise of the Empowered Patient, in FDA in the 21st Century (Holly Fernandez Lynch & I. Glenn Cohen eds., 2015) [hereinafter Grossman 2015].

51 Jim Elgo, et al., FDA Action Handbook, ACT UP New York (Sept. 12, 1988), http://www.actupny.org/documents/FDAhandbook1.html [https://perma.cc/EM47-3E26].

52 Lewis A. Grossman, The Origins of American Health Libertarianism, 13 Yale J. Health Pol'y L. & Ethics 76, 118–20 (2013) [hereinafter Grossman 2013]; Lewis A. Grossman, Orthodoxy and “The Other Man's Doxy”: Medical Licensing and Medical Freedom in the Gilded Age, in You Can Choose Your Medicine: Freedom of Therapeutic Choice in American History and Law (forthcoming) [hereinafter Grossman Forthcoming Publication].

53 See Marc Stein, American Social and Political Movements of the 20th Century: Rethinking the Gay and Lesbian Movement 157–163 (2012); Sean Strub, Condomizing Jesse Helms' House, The Huffington Post (July 25, 2008), http://www.huffingtonpost.com/sean-strub/condomizing-jesse-helms-h_b_113329.html [https://perma.cc/D3DS-GANWJ]; ACTUP Capsule History 1989, ACT UP (last updated Apr. 10, 2013) http://www.actupny.org/documents/cron-89.html [https://perma.cc/SZ48-CSCE]; Surviving and Thriving AIDS Activism: Then and Now, U.S. National Library of Medicine/National Institutes of Health (Sept. 16, 2013), https://www.nlm.nih.gov/exhibition/survivingandthriving/education/materials/AIDS-Activism-Materials.pdf [https://perma.cc/TSU4-A85P].

54 Epstein 1996, supra note 48, at 13–14, 229–32, 284–87.

55 Id. at 13.

56 Epstein 1996, supra note 48.

57 Carol Ballentine, Taste of Raspberries Taste of Death: The 1937 Elixir Sulfanilamide Incident, FDA Consumer, June 1981, available at http://www.fda.gov/aboutfda/whatwedo/history/productregulation/sulfanilamidedisaster/default.htm [http://perma.cc/G6PX-VTMC].

58 See 21 U.S.C. § 355(a), (b) (2016).

59 Federal Food, Drug and Cosmetic Act, Pub. L. No. 75-717 §505(d), 52 Stat. 1040, 1052 (1938).

60 Id. at §505(c)

61 Carpenter, supra note 5, at 213.

62 Id. at 238.

63 Accounts of the thalidomide crisis and Kelsey's role in it appear in id. at 213–97 and Morton Mintz, By Prescription Only: A Report on the Roles of the United States Food and Drug Administration, the American Medical Association, Pharmaceutical Manufacturers, and Others in Connection with the Irrational and Massive Use of Prescription Drugs that May be Worthless, Injurious, Or Even Lethal 248–64 (1967).

64 Drug Amendments of 1962, Pub. L. No. 87-781 § 103, 76 Stat. 780, 782–84 (1962) (codified as amended at 21 U.S.C. § 355(i)).

65 Id.

66 New Drugs; Procedural and Interpretative Regulations; Investigational Use, 28 Fed. Reg. 179 (Jan. 8, 1963). These regulations, as amended, are now at 21 C.F.R. Part 312 (2016).

67 28 Fed. Reg. at 180.

68 21 C.F.R. § 312.21(a) (2016).

69 Id. § 312.21(b).

70 Id. § 312.21(c).

71 Drug Amendments of 1962, Pub. L. No. 87-781 § 103, 76 Stat. 780, 782–84 (1962) (codified as amended at 21 U.S.C. § 355(a)).

72 Id. at 781 (codified at 21 U.S.C. § 355(d). FDA reviewers had in fact been taking efficacy considerations into account when considering NDAs since the late 1940s. CARPENTER, supra note 5, at 118–227.

73 Drug Safety (Part 1) Hearings Before a Subcomm. of the Comm. on Government Operations, 88th Cong. 150, 153–54 (1964) (statement of FDA Commissioner George P. Larrick).

74 § 102, 76 Stat. 780, 781 (codified as amended at 21 U.S.C. § 355(d)).

75 Food and Drug Admin. Guidance for Industry Providing Clinical Evidence of Effectiveness of Human Drugs and Biological Products 3 (1998). In 1997, Congress amended the FDCA to provide that FDA could deem “data from one adequate and well-controlled clinical investigation and confirmatory evidence … sufficient to constitute substantial evidence.” Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, § 115, 111 Stat. 2296, 2313 (1997) (codified at 21 U.S.C. § 355(d)).

76 Carpenter, supra note 5, at 296.

77 Id. at 136, 159 n.62. Agency reviewers were embracing this standard even before 1962. Id. at 175–82.

78 Hearing Regulations and Regulations Describing Scientific Content of Adequate and Well-Controlled Clinical Investigations, 35 Fed. Reg. 7250 (May 8, 1970) (codified at 21 C.F.R. § 314.126 (2016)).

79 21 C.F.R. § 314.126(e) (2016).

80 35 Fed. Reg. at 7251 (codified at 21 C.F.R. § 130.12(a)(5)(ii)(a)(4) (2016)).

81 Carpenter, supra note 5, at 374–80.

82 Hutt, Merrill, & Grossman, supra note 33, at 744–51.

83 Joseph, A. DiMasi, New Drug Development in the United States 1963 to 1999, 69 Clinical Pharmacology & Therapeutics 286, 291 (2001)Google Scholar.

84 FDA Action Handbook, supra note 51 (“The imperatives of science, law, bureaucracy and corporate property, which result in 8-10 year testing periods for most drugs, must yield to a synthesis with the needs of seropositives and PWA's who, untreated, will often live far less long.”).

85 Carpenter, supra note 5, at 433–42.

86 AIDS Drug Development and Related Issues: Hearing before a H. Subcomm. of the Comm. on Government Operations, 99th Cong. 103 (1986) (statement of Harry Meyer, Director, Center for Drugs and Biologics, Food and Drug Administration); see also Carpenter, supra note 5, at 433–38 (describing the AZT approval process).

87 Carpenter, supra note 5, at 441.

88 Then, as now, FDA interpreted the FDCA to permit doctors to prescribe already-approved drugs for unapproved uses.

89 Hutt, Merrill, & Grossman, supra note 33, at 768–70. For a list of major treatment protocols approved through March 1987, see FDA Proposals to Ease Restrictions on the Use and Sale of Experimental Drugs, 105th Cong. 104 (1987).

90 Peter Barton Hutt, Philosophy of Regulation Under the Federal Food, Drug and Cosmetic Act, 28 Food Drug Cosm. L.J. 177, 178–79 (1973).

91 Id. at 178.

92 Milton, Katz, The Function of Tort Liability in Technology Assessment, 38 U. Cin. L. Rev. 587, 593, 597 (1969)Google Scholar.

93 Richard, A. Merrill, The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753, 1843 (1996)Google Scholar.

94 Rutherford v. United States, 399 F. Supp. 1208 (W.D. Okla. 1975).

95 Id.

96 Rutherford v. United States, 582 F.2d 1234, 1237 (10th Cir. 1978).

97 United States v. Rutherford, 442 U.S. 544, 555 (1979). The plaintiffs also claimed that the FDA's ban on Laetrile violated their privacy rights under the Due Process Clause of the Fifth Amendment of the United States Constitution. They initially prevailed on this ground in the district court, but the court of appeals rejected this constitutional holding on remand from the U.S. Supreme Court. See Rutherford v. United States, 616 F.2d 455, 457 (10th Cir. 1980); Rutherford v. United States, 48 F. Supp. 1287 (W.D. Okla. 1977).

98 Thomas, O. McGarity, Regulatory Reform in the Reagan Era, 45 Md. L. Rev. 253, 261 (1986)Google Scholar.

99 See id. at 265–66.

100 Exec. Order No. 12,291, 3 C.F.R. 127 (1981).

101 Id. at 128.

102 New Drug and Antibiotic Regulations, 47 Fed. Reg. 46,622, 46,622 (Oct. 19, 1982).

103 Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations, 48 Fed. Reg. 26,720, 26,742 (June 9, 1983) (codified at 21 C.F.R. Part 312). “Treatment protocol” was the term attached to requests initiated by drug companies rather than physicians, but “treatment IND” became the generic term for all such requests.

104 Id. at 26,720 (citation omitted).

105 Id. at 26,723–24.

106 Id. at 26,729.

107 Id. at 26,742.

108 Id. at 26,734, 26,737.

109 Id. at 26,737.

110 In 1984, the FDA cleared the treatment use of ganciclovir, the previously-mentioned treatment for a blindness-inducing retinal infection common among PWAs. William, C. Buhles, Compassionate Use: A Story of Ethics and Science in the Development of a New Drug, 54 Persps. in Biol. & Med. 304 (2011)Google Scholar. This action suggested that the agency was prepared to open the gate wide for AIDS victims, for it allowed the compassionate use of ganciclovir based solely on laboratory evidence, before the manufacturer had even commenced human trials. Id. PWAs had to wait more than two years for the next compassionate use program, however, and this one—for AZT—was restricted to a particular subset of AIDS sufferers and commenced just a few months before the drug's ultimate approval. Caroline Rand Herron & Katherine Roberts, A Ray of Hope for AIDS Patients, N.Y. Times, Sept. 21, 1986; Carpenter, supra note 5, at 436–37.

111 See Philip Boffey, Reagan Defends Financing for AIDS, N.Y. Times, Sept. 18, 1985 (“[President Reagan's] remarks appeared to be the first time he has publicly addressed [AIDS].”).

112 Dale Gieringer, Twice Wrong on AIDS, N.Y. Times, Jan. 12, 1987, at A21.

113 Charles Krauthammer, Saying No to AIDS Patients: Which Ones Get AZT?, Wash. Post, Feb. 27, 1987, at A27.

114 Id.

115 This history is laid out, with supporting documentation, in FDA Proposals, supra note 89, at 94–105 (testimony of Frank E. Young).

116 Id. at 95.

117 Id.

118 Id.

119 The only notable concessions they appear to have won were, first, to apply the lower evidentiary burden only to drugs for “immediately life-threatening diseases” and, second, to publish the treatment IND provisions as a reproposal, rather than as a final rule along with the rest of the IND regulations. Investigational New Drug, Antibiotic, and Biological Drug Product Regulations; Treatment Use and Sale, 52 Fed. Reg. 19,466 (May 22, 1987).

120 52 Fed. Reg. 8,850, 8,855–57 (Mar. 19, 1987).

121 Id. at 8,856.

122 Id. The preamble explained that for immediately life-threatening diseases, “Requiring a degree of proof only slightly less than is necessary for general market distribution would unnecessarily restrict a drug that could provide real benefits in the particular case under treatment.” Id. at 8851.

123 48 Fed. Reg. at 26,742; 52 Fed. Reg. at 8,856. Because one condition for granting a treatment IND was that the drug be “under investigation in a controlled clinical trial under an IND,” the proposal seemed to contemplate that a treatment IND drug must at least have entered phase 2 studies. Id.

124 52 Fed. Reg. at 8,854.

125 Id. at 8,856.

126 FDA Proposals, supra note 89, at 2; Senator Kennedy submitted to the record a letter condemning the proposal. Id. at 155–56.

127 Id. at 127.

128 Weiss and Kennedy also voiced this concern. Id. at 2.

129 FDA Proposals, supra note 89, at 38 (testimony of Charles G. Moertel).

130 Id. at 32.

131 Id.

132 Id. at 100.

133 Id. at 5 (testimony of Richard M. Cooper).

134 Id.

135 Jonathan Kwitny, Acceptable Risks 148–49 (1992).

136 Gina Kolata, Odd Alliance Would Speed New Drugs, N.Y. Times, Nov. 26, 1988, at 9.

137 Id.

138 Frank Young had a meeting about the reproposal with the Pharmaceutical Manufacturer's Association (PMA), the trade association for large drug companies. FDA Proposals, supra note 89, at 70.

139 Investigational New Drug, Antibiotic, and Biological Drug Product Regulations; Treatment Use and Sale, 52 Fed. Reg. 19,466, 19,472 (May 22, 1987).

140 FDA Commissioner Frank Young later told Martin Delaney, a leading AIDS activist, that PMA “would not live with” the reproposal. Kwitny, supra note 135, at 192.

141 Editorial, Drug-Lag Defenders, Wall St. J., May 15, 1987.

142 52 Fed. Reg. 19,466.

143 Id. at 19,476 (codified at 21 C.F.R. § 312.34(b)(3)). The rule also allowed FDA to deny a treatment IND if the evidence as a whole failed to provide a reasonable basis for concluding that the drug “[w]ould not expose the patients … to an unreasonable and significant additional risk of illness or injury.” Id.

144 Id. at 19,476 (codified at 21 C.F.R. § 312.7(d)(2), (3)).

145 Editorial, Senator Helms and the Guilty Victims, N.Y. Times, June 17, 1987, at A30; Jesse Helms, Letter to the Editor, Only Morality Will Effectively Prevent AIDS from Spreading, N.Y. Times, Nov. 23, 1987, at A22; Morris S. Thompson, Bennett Urges Steps on AIDS in Jails, Wash. Post, June 15, 1987, at A14.

146 Joseph Berger, AIDS Patients Pose Difficult New Test for Clerics, N.Y. Times, Jan. 10, 1986, at A14.

147 See Bowers v. Hardwick, 478 U.S. 186 (1986).

148 In Depth: Topics A to Z: Gay and Lesbian Rights, Gallup, http://www.gallup.com/poll/1651/gay-lesbian-rights.aspx.

149 CDC Fact Sheet, supra note 2, at 2.

150 Life, Cover, July 1985.

151 Philip Ziegler, The Black Death 100–02 (rept. ed., 2009).

152 Fran Smith, Anxiety Over AIDS Prompts Attacks Against Gays, Phila. Inquirer, Jan. 27, 1985, at C3.

153 Philip M. Boffey, Bush Favors Requiring AIDS Tests for Marriage License Application, N.Y. Times, April 9, 1987, at B8.

154 William F. Buckley, Jr., Opinion, Identify All the Carriers, N.Y. Times, Mar. 18, 1986, at A27.

155 Michael Hirsley, Talk of AIDS Quarantine Spreads Like a Disease, Chicago Tribune, Nov. 12, 1985, at 1; Thompson, supra note 145.

156 Richard Restak, Worry About Survival of Society First; Then AIDS Victims' Rights, Wash. Post, Sept. 8, 1985, at C01.

157 Id.

158 Transcript of Interview with Gregg Bordowitz, AUOHP (Dec. 12, 2002) at 31, http://www.actuporalhistory.org/interviews/images/bordowitz.pdf [https://perma.cc/9ZSR-DVNS].

159 Id. at 31–32.

160 See Deborah Gould, Rock the Boat, Don't Rock the Boat, Baby: Ambivalence and the Emergence of Militant AIDS Activism, in Passionate Politics: Emotions and Social Movements 135, 152–55 (Jeff Goodwin, James M. Jasper, & Francesca Polletta eds., 2001) [hereinafter Gould, Rock the Boat]; Deborah B. Gould, Moving Politics: Emotion and Act Up's Fight Against Aids (2009) [hereinafter Gould, Moving Politics].

161 Kwitny, supra note 135, at 148.

162 Id.

163 Elaine Woo, Obituary, Martin Delaney, 1945–2009, L.A. Times, January 27, 2009, at B5.

164 Kwitny, supra note 135, at 149.

165 The Task Force was officially disbanded in August 1983 and reconstituted in December 1986. On Gray, see Kenneth B. Noble, Fulfilling a Promise on Deregulation, N.Y. Times, August 29, 1983, at A16.

166 Kwitny, supra note 135, at 187.

167 Id.

168 Id.

169 Hutt, Merrill & Grossman, supra note 33, at 772. In 1977, the FDA Regulatory Procedures Manual was amended to explicitly allow importation of personal use quantities of unapproved drugs by individuals in their baggage or by mail. Id.

170 See Kwitny, supra note 135, at 154; FDA Action Handbook, supra 51; Robert Reinhold, Infected But Not Ill, Many Try Unproved Drug to Block AIDS, N.Y. Times, May 20, 1987.

171 See, e.g., Marilyn Chase, For Some AIDS Patients, Bootleg Drugs Are One Way to Preserve Some Hope, Wall St. J., Oct. 5, 1987. For descriptions of smuggling operations, see Kwitny, supra note 135.

172 Kwitny, supra note 135, at 195–97.

173 Id. at 203–07.

174 Philip M. Boffey, F.D.A. Will Allow AIDS Patients to Import Unapproved Medicines, N.Y. Times, July 24, 1988; FDA Office of Regional Operations, Pilot Guidance for Release of Mail Importations (July 24, 1988).

175 William, Booth, An Underground Drug for AIDS, 241 Science 1279, 1279 (1988)Google Scholar.

176 In accordance with the agency's longstanding approach, the policy was limited to personal use quantities not intended for commercial distribution. Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, Food and Drug Law: Cases and Materials 664–65 (3rd ed. 2007) (citing FDA Office of Regional Operations, Pilot Guidance for Release of Mail Importations (1988)). Indeed, the guidance added a new condition by requiring that the patient provide a written affirmation that the product was for his own use. Id. Two days after its initial story, the N.Y. Times itself acknowledged the limited significance of the Guidance. Philip M. Boffey, Importing AIDS Drugs: Analysis of F.D.A. Policy, N.Y. Times, July 26, 1988, at C1. An FDA “Talk Paper” explaining the new guidelines presented them as an affirmation of existing policy. Brad Stone, FDA Talk Paper: Policy on Importing Unapproved AIDS Drugs for Personal Use (July 17, 1988).

177 See Loraine Sommella, This is about People Dying: The Tactics of Early ACT UP and Lesbian Avengers in New York City, AUOHP (last visited Oct. 17, 2016), http://www.actupny.org/documents/earlytactics.html.

178 FDA Proposals, supra note 89, at 132.

179 Id.

180 See Kwitny, supra note 135, at 150.

181 Patrick Healy, Larry Kramer to be Honored by Gay Men's Health Crisis, N.Y. Times (Feb. 6, 2015).

182 Randy Shilts, And The Band Played on: Politics, People, and The Aids Epidemic 135, 166–67, 209–10, 275, 309–11 (2000).

183 Transcript of Interview with Larry Kramer, AUOHP (Nov. 15, 2002) at 7–8, http://actuporalhistory.org/interviews/images/kramer.pdf [https://perma.cc/S2AS-MR38]..

184 See Nesline interview, supra note 20, at 8–9, Transcript of Interview with Maxine Wolfe, AUOHP (Feb. 19, 2004) at 40–42, http://actuporalhistory.org/interviews/images/wolfe.pdf [https://perma.cc/L99D-8JUJ] [hereinafter Wolfe interview], and Transcript of Interview with Ron Goldberg, AUOHP (Oct. 25, 2003) at 59–60, http://actuporalhistory.org/interviews/images/goldberg.pdf [https://perma.cc/GD6K-YZLY] [hereinafter Goldberg interview] for more on the first meetings.

185 See Nesline interview, supra note 20, at 8–9; Wolfe interview, supra note 184, at 40–42; Goldberg interview, supra note 184, at 59–60.

186 Larry Kramer, The F.D.A.'s Callous Response to AIDS, N.Y. Times, Mar. 23, 1987, at A19.

187 Id.

188 Id.

189 Id.

190 Linda Hirshman, Victory: The Triumphant Gay Revolution 197 (reprint ed. 2013).

191 Carpenter, supra note 5, 393–461.

192 Id.

193 FDA Resumes Business After AIDS Demonstration, supra note 11, at 7.

194 5 U.S.C. § 553(c) (2012).

195 See, e.g., U.S. v. Nova Scotia Food Products, 568 F.2d 240 (2d Cir. 1977) (requiring preambles accompanying final rules to address points raised by commenters).

196 5 U.S.C. § 553(e) (2012).

197 Gregg Bordowitz interview, supra note 158, at 23 (paraphrasing Barr and Wheatley). The notion of conducting a demonstration at the FDA building was not in fact as unprecedented as these men believed. In 1975, the Women's National Health Network conducted a much smaller demonstration there—a “memorial service” to protest the agency's labeling policies for hormone-containing drugs. Sandra Morgen, Into Our Own Hands: The Women's Health Movement in the United States, 1969–1990 29 (1st ed. 2002). Nevertheless, David Barr continues to believe “there had never been a demonstration at the Food and Drug Administration before, ever.” Transcript of Interview with David Barr, AUOHP (May 15, 2007) at 36, http://www.actuporalhistory.org/interviews/images/barr.pdf [https://perma.cc/PJ2M-RX2P] [hereinafter Barr interview].

198 Bordowitz interview, supra note 158, at 23 (paraphrasing Barr and Wheatley).

199 Sidney Tarrow examines the “outsiders inside” phenomenon in social movements extensively in Sidney Tarrow, Strangers at the Gates: Movements and States in Contentious Politics (2012).

200 Transcript of Interview with Mark Harrington, AUOHP (Mar. 8, 2003) at 45, http://www.actuporalhistory.org/interviews/images/harrington.pdf [https://perma.cc/Y6XF-VEH8] [hereinafter Harrington interview]; Transcript of Interview with David Kirschenbaum, AUOHP (Oct. 19, 2003) at 45, http://www.actuporalhistory.org/interviews/images/kirschenbaum.pdf [https://perma.cc/77SJ-VYE5] [hereinafter Kirschenbaum interview].

201 Sidney Tarrow, Power in Movement: Social Movements, Collective Action and Politics (Peter Lange et al eds., 1994); Charles Tilly, From Mobilization to Revolution (1978); Doug Mcadam, Political Process and the Development of Black Insurgency, 1930–1970 (2nd ed. 1999).

202 Tarrow, supra note 201, at 18.

203 Gould, Rock the Boat supra note 166, at 136; see also Gould, Moving Politics supra note 160, at 10–14. Steven M. Engel, by contrast, believes that political opportunity structure provides a useful framework for analyzing the AIDS movement. Stephen M. Engel, The Unfinished Revolution: Social Movement Theory and the Gay and Lesbian Movement 14, 47–53, 100 (2001).

204 See generally Gould, Moving Politics supra note 160.

205 Poll, Pfizer Pharmaceuticals (Jan. 25 – Feb. 11, 1979) (available on “iPoll” on Roper Center website).

206 Poll, The Roper Center for Public Opinion Research (May 5 – May 13, 1989). In 1988, sixty-eight percent of respondents to a different poll said they favored the early access provided by the recently published Treatment IND rule. Poll, American Medical Association, Feb. 1 – Feb. 15, 1988, http://www.ropercenter.edu/pollldatabase.

207 Crossfire (CNN television broadcast, excerpted in How to Survive a Plague and at https://www.youtube.com/watch?v=ZUCUAEZsBuU [https://perma.cc.26MN]).

208 Boffey, supra note 8; Carpenter, supra note 5, at 445 (“AIDS activists were aware that their demands … dovetailed with a long-running conservative poltical agenda for pharmaceutical deregulation …. ”).

209 Kolata, supra note 136.

210 Id.

211 Consider, for example, the alliance between progressives and Spencerian conservatives in opposition to medical licensing in the Gilded Age. Grossman, supra note 52.

212 Ronald Reagan: Inaugural Address, http://www.presidency.ucsb.edu/ws/?pid=43130 (last visited Nov 11, 2015).

213 Larry Kramer, A “Manhattan Project” for AIDS, N.Y. Times, July 16, 1990, at A15.

214 Erik Eckholm, AIDS: Scientists Voice Concern Over Research, N.Y. Times, Nov. 4, 1986; See generally Judith A. Johnson & Sharon Coleman, Cong. Research Serv., FY1981–FY2006, AIDS Funding for Federal Government Programs: FY1981–FY2006, http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3073103232005.pdf (last visited July 20, 2015).

215 Bernard Weinraub, Reagan Orders AIDS Report, Giving High Priority to Work for Cure, N.Y. Times, February 6, 1986, at B7; Eckholm, supra note 214; See generally AIDS Funding for Federal Government Programs: FY1981–FY2006 - RL3073103232005.pdf, supra note 214.

216 Editorial, An AIDS Crisis Proposal, Wall Street Journal, June 15, 1988, at 1; Editorial, AIDS and 1962, Wall St. J., July 14, 1988, at 26.

217 Kolata, supra note 136.

218 ACT UP, FDA Action Handbook 9-12-88, http://www.actupny.org/documents/FDAhandbook1.html [https://perma.cc/3875-H4H2] (last visited July 20, 2015).

219 Warren Leary, Panel Seeks to Streamline F.D.A. for Cancer and AIDS Drugs, N.Y. Times, Jan. 5, 1989, at B12.

220 Final Report of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and Aids, viii (1990).

221 Quoted in Laurie Garrett, Discovery: The Battle over FDA Drug Policy, Newsday, February 14, 1989, at 1.

222 Grossman 2013, supra note 52, at 112–123; Grossman Forthcoming Publication, supra note 52.

223 Denver Principles, http://www.actupny.org/documents/Denver.html (last visited Aug. 5, 2015).

224 Transcript of Interview with Jim Eigo, AUOHP, (Mar. 5, 2004) at 16–17, http://www.actuporalhistory.org/interviews/images/eigo.pdf [https://perma.cc/9PWV-E6H4].

225 See, e.g., American Hospital Association, Patients’ Bill of Rights (1973), reprinted in Ruth R. Faden Johns Hopkins University School of Public Health & Tom L. Beauchamp Georgetown University, A History and Theory of Informed Consent 93 (1986).

226 Kevin Michael DeLuca, Unruly Arguments: The Body Rhetoric of Earth First!, ACT UP, and Queer Nation, 36 Argumentation & Advocacy 9–21 (1991).

227 See, e.g., Transcript of Interview with Jean Carlomusto, AUOHP, (Dec. 19, 2002) at 12, http://www.actuporalhistory.org/interviews/images/carlomusto.pdf [https://perma.cc/UX7L-VWVP] [hereinafter Carlomusto interview]; Transcript of Interview with Marion Banzhaf, AUOHP, (Apr. 18, 2007) at 15–21, http://www.actuporalhistory.org/interviews/images/Banzhaf.pdf [https://perma.cc/TS5Y-E4E] [hereinafter Banzhaf interview]; Transcript of Interview with Rita Denenberg, AUOHP, (July 11, 2008) at 9–19, http://www.actuporalhistory.org/interviews/images/Denenberg.pdf [https://perma.cc/C7HV-77EK] [hereinafter Denenberg interview]; Maxine Wolfe interview, supra note 184, at 21–22, 28–32.

228 For instance, ACT UP's Women's Caucus in New York City compiled an enormous handbook on the women's health movement and presented it in a “teach-in” to hundreds of men. Barbara Seaman, Health Activism, American Feminist | Jewish Women's Archive, http://jwa.org/encyclopedia/article/health-activism-american-feminist [https://perma.cc/MS2Z-8C5U] (last visited July 23, 2015).

229 Transcript of Interview with Robert Vazquez-Pacheco, AUOHP, (Dec. 14, 2002) at 63, http://www.actuporalhistory.org/interviews/images/vazquez.pdf [https://perma.cc/TS5Y-ER4E] [hereinafter Vazquez-Pacheco Interview]. Risa Denenberg, a leader of the ACT UP Women's Caucus, explained that feminism contributed directly to the PWA empowerment ideology, in particular the “empowerment that takes place … when concepts change about things that are as basic as who has control over your body. So if it came up to something like drugs into bodies, it was just nice to kind of have that perspective.” Denenberg interview, supra note 227, at 33.

230 Transcript of Interview with Heidi Dorow, (Apr. 17, 2007) at 31, http://www.actuporalhistory.org/interviews/images/Dorow.pdf [https://perma.cc/T7E6-JQWA] [hereinafter Dorow interview].

231 Transcript of Interview with Brian Zabcik, (Sept. 8, 2008) at 40 http://www.actuporalhistory.org/interviews/images/Zabcik.pdf [https://perma.cc/2XUM-7YW7] [hereinafter Zabcik interview].

232 Transcript of Interview with Steve Quester, (Jan. 17, 2004) at 16 http://www.actuporalhistory.org/interviews/images/quester.pdf [https://perma.cc/Z82M-379B] [hereinafter Quester interview].

233 Jim Serafini, ACT UP's Challenge to the Establishment, San Francisco Chronicle, June 20, 1990, at A19.

234 Sam Kazman, Protected to Death: The FDA's Misbegotten AIDS Rules are Killing with Kindness, Wash. Post, July 16, 1989, at B5.

235 Early Availability of Drugs for Serious or Life-Threatening Diseases: Hearing Before the Antiviral Drugs Advisory Comm., 177–178 (1994) (statement of Mark Milano, Member, ACTUP New York).

236 To the extent that AIDS activists embraced a vision of economic freedom, it was expressed in their occasional objections to a purportedly corrupt alliance between FDA and large pharmaceutical companies to block new drugs from the market. Martin Delaney voiced such suspicions. Kwitny, supra note 135, at 180, 193.

237 Procedures for Drugs Intended to Treat Life-Threatening and Severely Debilitating Illnesses, 53 Fed. Reg. 41,516, 41,516 (Oct. 21, 1988).

238 Id.

239 Editorial, The FDA for Itself, Wall St. J., Oct. 13, 1988, at A22.

240 53 Fed. Reg. 41,516; Michael Specter, FDA Amends Rules to Speed AIDS Drugs, Wash. Post, Oct. 20, 1988, at A1.

241 Id. In the rule's preamble, FDA stressed that it had “met informally with representatives of AIDS interest groups.” 53 Fed. Reg. at 41,516.

242 Expedited Approval of Drugs for Serious or Life-threatening Diseases or Conditions, 21 U.S.C. § 356(b), (d) (2015).

243 Charging for Investigational Drugs under an IND, 21 C.F.R. § 312.82 (2016).

244 Id. at § 312.84(a).

245 53 Fed. Reg. at 41,520.

246 Id. at 41,518.

247 Specter, supra note 240.

248 Warren Leary, F.D.A. Announces Changes to Speed Testing of Drugs, N.Y. Times, Oct. 20, 1988, at A1.

249 Specter, supra note 240; Leary, supra note 248.

250 In June 1989, FDA approved two drugs intended to treat secondary infections suffered by PWAs: aerosol pentamidine, for a severe type of pneumonia, and ganciclovir, for cytomegalovirus retinitis.

251 The new Subpart E regulations stated that FDA could invite sponsors to seek treatment INDs—but only if “the preliminary analysis of phase 2 test results appears promising.” 21 C.F.R. 312.83 (2015). In the views of patient advocates, the treatment IND was used primarily “as a bridge between Phase III and the NDA while FDA reviewed the data.” Jeffrey Levi, Unproven AIDS Therapies: The Food and Drug Administration and ddI, in Biomedical Politics 9, 14 (Kathi E. Hanna ed., 1991).

252 Martin Delaney, The Case for Patient Access to Experimental Therapy, Address Before the 26th Annual Meeting of the Infectious Diseases Society of America (Oct. 27–28, 1988), in 159 J. Infect. Dis. 416, 416 (1989).

253 Id.

254 Id. at 416.

255 Id. at 417.

256 Id.

257 Id.

258 Id. at 418.

259 Id.

260 Id.

261 Id. at 417.

262 Id. at 419.

263 ACT UP/New York, A National Aids Treatment Research Agenda, V International Conference on Aids, Montreal (June 1989) (revised Sept. 1989). Excerpts of the Montreal press conference introducing the Agenda appear at 35’, 35” of the documentary How to Survive a Plague. The agenda was presented by Peter Staley, Mark Harrington, Jim Eigo, and Iris Long.

264 Id. at 6.

265 Id. at 7.

266 Id. at 6–7.

267 Id. at 7.

268 Gina Kolata, AIDS Researcher Seeks Wide Access to Drugs in Tests, N.Y. Times, June 26, 1989, at A1; Levi, supra note 251, at 15–16.

269 Kwitny, supra note 135, at 218, 224, 235–36.

270 ACT UP Capsule History 1989, AIDS Coalition to Unleash Power, June 4–9, 1989 http://www.actupny.org/documents/cron-89.html [https://perma.cc/8C57-RCU4] (last visited Oct. 15, 2016].

271 Kolata, supra note 268; Victor F. Zonana & Marlene Cimons, Ease AIDS Drug Rules, Health Chief Urges, Los Angeles Times, June 24, 1989, at 23; Levi, supra note 251, at 16.

272 Zonana and Cimons, supra note 271.

273 Levi, supra note 251, at 14.

274 Kolata, supra note 268.

275 Levi, supra note 251, at 16.

276 AIDS Issues: Parallel Track Proposal for Clinical Drug Development: Hearing before the Subcomm. on Health and the Env't of the H. Comm. on Energy and Commerce, 101^st Cong. 5–26 (1989) (statements of James O. Manson, Assistant Sec'y for Health, Pub. Serv., Dep't of Health and Human Servs., accompanied by Frank E. Young, Comm'r, Food and Drug Admin.; Anthony S. Fauci, Nat'l Inst. of Allergy and Infectious Diseases, Mat'l Inst. of Health; Samuel Broder, Dir., Nat'l Cancer Instit.)

277 Id. at 1 (statement of Henry A. Waxman, Chairman, Subcomm. on Health and the Env't of the H. Comm. on Energy and Commerce).

278 Id. at 6–7 (Mason), 9 (Young).

279 Id. at 11 (Mason).

280 Id. at 10 (Mason).

281 Id. at 10 (Fauci).

282 Id. at 30 (statement of Martin Delaney, on behalf of Project Inform and ACT UP San Francsico).

283 Id. at 28–29 (Delaney).

284 Id. at 41 (statement of Jim Eigo, on behalf of AIDS Coalition to Unleash Power).

285 Id. at 19 (Mason, Young).

286 Anti-Infective Drugs Advisory Comm. of the Food and Drug Admin., Transcript of Proceedings (Aug. 17, 1989) (unpublished transcript) (on file with the American Journal of Law & Medicine).

287 Id. at 83–85 (Eigo), 86, 90–91 (Delaney).

288 Id. at 80, 84 (Eigo), 88, 99 (Delaney).

289 Id. at 77 (Eigo).

290 Id. at 93.

291 Id. at 171 (Roland). Derrick Hodel of the PWA Health Group similarly opined: “Our position has always been that given low toxicity, people have the right to acquire drugs that they feel might be efficacious.” Id. at 162.

292 Id. at 172 (Roland), 193 (Kramer).

293 Id. at 131–32 (Levi).

294 Id. at 194 (Kramer).

295 Id. at 156–57 (Wolfe).

296 Id. at 218–19 (Schulz), 147.

297 AIDS Issues: Parallel Track Proposal for Clinical Drug Development, supra note 276, at 21–22 (Mason).

298 Transcript of Proceedings, supra note 292, at 74 (Eigo); AIDS Issues: Parallel Track Proposal for Clinical Drug Development, supra note 276, at 40.

299 Transcript of Proceedings, supra note 286, at 179–80 (Harrington).

300 Id. at 133–34 (Levi), 158 (Wolfe).

301 At the advisory committee meeting, FDA Commissioner Young announced the submission of the ddI treatment IND application and promised to respond to it within thirty days. Id. at 16 (Young).

302 Levi, supra note 251, at 26–28.

303 Expanded Availability of Investigational New Drugs Through a Parallel Track Mechanism for People with AIDS and HIV-related Disease, 55 Fed. Reg. 20,856 (May 21, 1990). Interestingly, parallel track was never published in the form of a proposed or final rule.

304 Id.

305 Id. at 20,858. The proposed policy actually referred to “standard therapy,” rather than AZT in particular, but at the time AZT was the only one.

306 Id. at 20,857.

307 Eligibility for parallel track was thus limited to patients that failed to meet the controlled trials' entry criteria, were too ill to participate, or could not participate without undue hardship (for example, because of geographic distance), or to situations in which the controlled studies were already fully enrolled.

308 Id. at 20,859.

309 Id. at 20,858.

310 Final Report of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS, supra note 220, at 11–12. The report also supported the use of treatment INDs earlier in the drug development process, a recommendation essentially identical to parallel track. Id. at 10–11.

311 Id. at 11.

312 Id.

313 Id. at 7.

314 Expanded Availability of Investigational New Drugs Through a Parallel Track Mechanism for People with AIDS and Other HIV-related Disease, 57 Fed. Reg. 13,250 (April 15, 1992). To ensure the continuation of controlled research, some commenters urged the FDA to prohibit the commencement of any parallel track program prior to the full enrollment of phase 2 trials. The agency declined to take this step, pointing out that patients were ineligible for parallel track protocols unless they could not participate in the controlled trials, in any event. Id. at 13,251–52.

315 Gould, Moving Politics supra note 160, at 328–394.

316 Transcript of Interview with Tracy Morgan, AUOHP, (Oct. 12, 2012) at 43, http://www.actuporalhistory.org/interviews/images/morgan,pdf [https://perma.cc/2LHZ-KCNN] [hereinafter Morgan Interview].. This PI was an African-American woman, and the controversy thus illustrated the complexity of ACT UP racial politics.

317 Gould, Moving Politics supra note 160, at 366; Morgan Interview, supra note 316. The range of federal officials and discussions that would have been subject to this moratorium is unclear.

318 Id. at 52.

319 New Drug, Antibiotic, and Biological Drug Product Regulations: Accelerated Approval, 57 Fed. Reg. 58, 942, 58,958 (Dec. 11, 1992) (codified at 21 C.F.R. § 314.510).

320 Final Report of the National Committee to Review Current Procedures for Approval of new Drugs for Cancer and Aids, supra note 220, at iii–iv.

321 Gina Kolata, Petition Seeks to Speed Approval of AIDS Drugs, N.Y. Times, Dec. 21, 1990, at A31.

322 Supra text accompanying notes 301-02.

323 Malcolm Gladwell, Second AIDS Drug Given Conditional Approval; FDA Allows Sale on Basis of Incomplete Tests, Wash. Post, Oct. 10, 1991, at A4; Milt Freudenheim, F.D.A. Approves a Second Drug, Still Being Tested, to Treat AIDS, N.Y. Times, Oct. 10, 1991, at B2.

324 Freudenheim, supra note 323.

325 Council on Competitiveness and FDA Plans to Alter the Drug Approval Process at FDA Before the Human Res. and Intergovernmental Relations Subcomm. of the H. Comm. on Gov. Operations, 102d Cong. 176 (1992) (statement of the White House Press Secretary).

326 Robert Pear, The Federal Budget: The Overview; Mood of Compromise Prevails on Election-Year Budget, N.Y. Times, Jan. 31, 1992, at A14.

327 Council on Competitiveness and FDA Plans to Alter the Drug Approval Process at FDA Before the Human Res. and Intergovernmental Relations Subcomm. of the H. Comm. on Gov. Operations, 102d Cong. 194 (1992) (letter from Allan B. Hubbard, Exec. Dir., Council on Competitiveness, to David Kessler, Comm'r, Food and Drug Admin.).

328 Council on Competitiveness Fact Sheet: Improving the Nation's Drug Approval Process (1991), http://quod.lib.umich.edu/c/cohenaids/5571095.0474.099 [https://perma.cc/VM7W-83QG].

329 57 Fed. Reg. 13,234 (April 15, 1992) (codified at 21 C.F.R. § 314.510 (2011)).

330 Id. at 13240. The proposed rule also permitted accelerated approval in situations in which the agency concluded that the drug could be safely used only if subject to restrictions on its distribution or use. Id.

331 Id.

332 Marlene Cimons, FDA Approves AIDS Drug for Use with AZT, Los Angeles Times, June 23, 1992, at A1; 3d AIDS Drug Wins Conditional Approval, N.Y. Times, June 23, 1992, at C11.

333 New Drug, Antibiotic, and Biological Drug Product Regulations: Accelerated Approval, 57 Fed. Reg. 58,942 (Dec. 11, 1992).

334 Mark Harrington, Introduction, in Ten Texts on Saquinavir: Its Rapid Rise and Fall 1, 3 (Mark Harrington ed., 2001).

335 Id. at 3.

336 Id. at 7.

337 Id. at 8; Laurie Garrett, Battle on AIDS Drugs, Newsday, Sept. 6, 1994, at 4.

338 Garrett, supra note 266.

339 Treatment Action Group, ACTG 229: AZT/ddC/Saquinavir vs. AZT/Saquinavir v. AZT/ddC (May 1994), in Ten Texts on Saquinavir: Its Rapid Rise and Fall 12–13 (Mark Harrington ed. 2001).

340 Harrington, supra note 334, at 9.

341 Letter from David Barr et al. to David Kessler, FDA Commissioner (June 16, 1994), in Ten Texts on Saquinavir: Its Rapid Rise and Fall 6, 9, 14 (Mark Harrington ed. 2001).

342 Id. at 14–15.

343 Id. at 15.

344 How to Survive a Plague (Netflix 2012) at 1:32:00–34:00. A group of TAG representatives, including Harrington and Gonsalves, attended the subsequent ACT UP meeting and tried to defend their actions. Id.

345 Early Availability of Drugs for Serious or Life-Threatening Diseases, supra note 235, at I-145–51, 193–96 (testimony of Waijen Soo, Hoffman-LaRoche, and Andre Pernet, Abbott Laboratories).

346 Mark Harrington, Access versus Answers (1996 Version), in Ten Texts on Saquinavir: Its Rapid Rise and Fall 6, 10 (Mark Harrington ed., 2001).

347 Early Availability of Drugs for Serious or Life-Threatening Diseases, supra note 235, at 1-388-89.

348 See Placebos: Time to Say No, 5 PI Perspective (Project Inform, San Francisco, Cal.) Oct. 1988, at 1–4, for Martin Delaney's call to ban the use of placebos in clinical studies when alternative controls are possible.

349 Transcript of Proceedings, supra note 286, at 178 (Harrington).

350 Indeed, since the approval of AZT, the FDA had prohibited placebo-only arms in AIDS trials. Investigational New Drug, Antibiotic, and Biological Drug Product Regulations; Procedures for Drugs Intended to Treat Life-threatening and Severely Debilitating Illnesses, 53 Fed. Reg. 41,516, 41,519 (Oct. 21, 1988).

351 Early Availability of Drugs for Serious or Life-Threatening Diseases, supra note 235, at I-385 (Delaney).

352 Id. at I-129 (King).

353 Id. at I-78.

354 Id. at II-70 (Haas), II-109–110 (Onstott). Onstott decried the “assumption that most people with AIDS and other life-threatening illnesses are too naive, ignorant and/or desperate to make rational and informed treatment choices” as “an insidious and paternalistic assumption that many bureaucrats, physicians, politicians and even a few AIDS activists share.” Id. at 110.

355 Id. at II-104 (Schaich).

356 It was unclear how much evidence of effectiveness TAG would demand before supporting accelerated approval of a drug. Although the letter to Kessler intimated that saquinavir should not be eligible for approval until completion of the LST, Harrington moderated this stance at the hearing: “The answers don't have to be in by the time accelerated approval occurs, but it would be useful to have some kind of confidence greater than we have now that those answers would indeed be forthcoming.” Id. at I-291 (Harrington). This was hardly an extreme position; after all, the accelerated approval rule itself stated that postmarketing studies “would … usually be … already underway” at the time of approval. 57 Fed. Reg. at 58,958 (codified at 21 C.F.R. § 314.510). Nonetheless, TAG seemed to continue to want at least preliminary evidence prior to accelerated approval; Harrington stated that approval would be appropriate only if and when the “surrogate markers show [clinical] benefit.” Early Availability of Drugs for Serious or Life-Threatening Diseases, supra note 235, at I-293 (Harrington).

357 Early Availability of Drugs for Serious or Life-Threatening Diseases, supra note 235, at II-36 (Cox).

358 Id. at II-43 (Cox) (emphasis added).

359 Id. at II-45 (Bahlman).

360 Id. at I–379.

361 Id. at II-17.

362 The company's failure to complete these trials was less clearly blameworthy than TAG suggested. For discussion of ddC's post-approval clinical program, see id. at 136–52.

363 Id. at I-292 (Harrington), II-36–8, 41 (Cox), II-42 (Gonsalves), II-142 (Link).

364 Id. at I–108 (Hogan); Letter from David Barr et al. to David Kessler, supra note 347, at 14.

365 Early Availability of Drugs for Serious or Life-Threatening Diseases, supra note 235, at II–36 (Cox).

366 Id. at I-123–24 (Davidson).

367 Id. at I-377 (Delaney).

368 Id. at I-75 (Freiburg).

369 Id. at II-313–13 (Feigal).

370 Id. at I-154 (Soo).

371 Mark Harrington, Access Versus Answers (1996 Version), in Ten Texts on Saquinavir: Its Rapid Rise and Fall, supra note 346, at 10, 25.

372 FDA Approves First Protease Inhibitor Drug for Treatment of HIV, U.S. Dep't of Health and Human Servs. (Dec. 7, 1995), http://archive.hhs.gov/news/press/1995pres/951207.html [https://perma.cc/3NR9-8Y3J].

373 Spencer Cox, Giving Away the Farm: How Corporate Cynicism, Savvy Schmoozing and Relentless PR Paved the Way to Unqualified Approval for Two New Antiretrovirals (1995), in Ten Texts on Saquinavir: Its Rapid Rise and Fall, supra note 346, at 29.

374 These drugs were Norvir (ritonavir) (1996), Crixivan (indinavir)(1996), and Viracept (nelfinavir) (1997).

375 Eskridge & Ferejohn, supra note 31, at 33.

376 Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, § 112, 111 Stat. 2296, 2309–10 (1997) (codified at 21 U.S.C. § 356).

377 Id.

378 Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, § 901, 902, 126 Stat. 993, 1082–88 (2012) (codified at 21 U.S.C. § 356).

379 § 112, 111 Stat. 2296, 2365–67.

380 Treatment IND or Treatment Protocol, 21 C.F.R. 312.320(a)(3)(ii) (emphasis added); Expanded Access to Investigational Drugs for Treatment Use, 74 Fed. Reg. 40,900, 40,910–11, 40,945 (August 13, 2009).

381 Susanna, L. Rose, Patient Advocacy Organizations: Institutional Conflicts of Interest, Trust, and Trustworthiness, 41 J.L. Med. & Ethics 680, 681 (2013)Google Scholar (between 30% and 71% of patient advocacy organizations receive funding from the pharmaceutical industry).

382 Patient Representative Program, U.S. Food & Drug Admin., http://www.fda.gov/downloads/forconsumers/byaudience/forpatientadvocates/patientinvolvement/ucm14 [https://perma.cc/3NR9-8Y3J].

383 Bill Clinton & Al Gore, National Performance Review, Reinventing the Regulation of Cancer Drugs: Accelerating Approval and Expanding Access 9 (1996), http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4191B1_01_03-Reinvent-Cancer-Drugs.pdf [https://perma.cc/FRR74EKK].

384 Historical Overview Information—Cancer Patient Representative Program, U.S. Food & Drug Admin., http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/cancerliaisonprogram/ucm147019.htm [https://perma.cc/G833-K4FB].

385 Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, § 1137, 126 Stat. 993, 1124 (2012) (codified in 21 U.S.C. § 360bbb–8c).

386 Id.

387 Id.

388 § 101(b), 126 Stat. at 996 (referring to goals identified in letters from the Secretary of Health and Human Services to the Chairmen of the relevant House and Senate Committees); PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 Through 2017, U.S. Food & Drug Admin., http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.

389 Webinar: Background on FDA and Patient-Focused Drug Development, U.S. Food & Drug Admin., http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm349133.htm (last visited May 13, 2014).

390 Patient-focused Drug Development: Disease Area Meetings Planned for Fiscal Years 2013–2017, U.S. Food & Drug Admin., http://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm347317.htm [https://perma.cc/R96B-23NX].

391 Meeting Notice and Request for Comments, 77 Fed. Reg. 58,848, 58,849 (Sept. 24, 2012).

392 Peter S. Arno & Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics And Profits 109 (Tom Miller ed., 1992).

393 FDAMA added section 903(b) (now 1003(b)) to the FDCA, stating that FDA's mission is, first, to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner,” and, second, to “protect the public health by ensuring that” these products are safe and effective. See Food and Drug Administration Modernization Act, Pub. L. No. 105-115, § 406, 111 Stat. 2296, 2369 (1997) (codified at 21 U.S.C. § 393(b)).

394 By March 1997, the agency had granted accelerated approval to about a dozen AIDS-related drugs. See supra note 374.

395 U.S. Food & Drug Admin., White Paper: FDA and Accelerating the Development of the New Pharmaceutical Therapies, http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm439082.htm [https://perma.cc/63US-W5BU].

396 Another FDA policy to expedite consideration of important new medicines is called Priority Review. See Center for Drug Evaluation & Research, U.S. Food & Drug Admin., Manual of Policies and Procedures 6020.3: Priority Review Policy (Apr. 22, 1996).

397 Matthew, C. Lovell, Second Thoughts: Do the FDA's Responses to a Fatal Drug Trial and the AIDS Activist Community's Doubts About Early Access to Drugs Hint at a Shift in Basic FDA Policy?, 51 Food & Drug L.J. 273, 274 (1996)Google Scholar; see also Sheila, R. Shulman & Jeffrey, S. Brown, The Food and Drug Administration's Early Access and Fast-Track Approval Initiatives: How Have They Worked?, 50 Food & Drug L.J. 503, 516 (1995)Google Scholar (stating that under pressure from AIDS patients, FDA's emphasis “is less on speeding the availability of new compounds than it is on establishing therapeutic value”).

398 Jacob W. Stahl, A History of Accelerated Approval: Overcoming the FDA's Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients (2005) (unpublished Third Year Paper, Harvard University) (on file with Digital Access to Scholarship at Harvard).

399 Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, 126 Stat. 993, 1083–86 (2012) (Findings; Sense of Congress, and Amendment of FD&C Act §506).

400 Prescription Drug User Fee Act of 1992, Pub. L. No. 102-571, 106 Stat. 4491–4505 (1992) (codified in 21 U.S.C. 301).

401 138 Cong. Rec. H9098 (daily ed. Sept. 22, 1992). See generally Bruce N. Kuhlik, Industry Funding of Improvements in the FDA's New Drug Approval Process: The Prescription Drug User Fee Act of 1992, 47 Food & Drug L.J. 483, 483–91 (1992).

402 Reauthorization of the Prescription Drug User Fee Act and FDA Reform: Hearing Before the Subcomm. on Health & Environment of the H. Comm. on Commerce, 105th Cong. 103 (1997) (statement of Jeff Bloom).

403 Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (1997); Prescription Drug User Fee Amendments of 2002, Pub. L. No. 107-188, 116 Stat. 594, 687–694 (2002); Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823, 825–42 (2007); Food and Drug Administration Safety and Innovation Act of 2012, 126 Stat. 993, 996–1008.

404 Hutt, Merrill, & Grossman, supra note 33, at 749–50.

405 See Denise Grady, U.S. Lets Drug Tied to Deaths Back on Market, N.Y. Times, June 8, 2002, http://www.nytimes.com/2002/06/08/us/us-lets-drug-tied-to-deaths-back-on-market.html.

406 Sabrina Tavernise, FDA Clears Debated Drug That Patients Lobbied For, N.Y. Times, Sept. 19, 2016, at B1.

407 Expanded Access INDs and Protocols 2009–14, Food & Drug Admin., http://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm443572.htm [https://perma.cc/Y4UJ-W6VS].

408 Id.

409 Expanded Access INDs and Protocols 2013–14, Food & Drug Admin., http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/INDActivityReports/UCM430188.pdf

410 Abigail Alliance for Better Access to Developmental Drugs v. Crawford, 495 F.3d 695, 697 (D.C. Cir. 2007) (en banc). Abigail Alliance is named after Abigail Burroughs, who died of cancer at twenty-one years old in 2001 after failing to gain access to two experimental drugs that the FDA later approved. I will discuss this case extensively in my forthcoming book. Lewis Grossman, You Can Choose Your Medicine: Freedom of Therapeutic Choice in American History and Law (forthcoming).

411 Charging for Investigational Drugs under an IND, 21 C.F.R. § 312.8(c).

412 74 Fed. Reg. 40,872, 40,883–85 (August 13, 2009) (codified at 21 C.F.R. Part 312). The rule states that a sponsor who wishes to charge for expanded access must provide FDA with “reasonable assurance that charging will not interfere with developing the drug for marketing approval,” including “[e]vidence of sufficient enrollment in any ongoing clinical trial(s)” and “[e]vidence of adequate progress in the development of the drug for marketing approval.” 21 C.F.R. § 312.8(c).

413 Benjamin R. Rossen, FDA's Proposed Regulations to Expand Acccess to Investigational Drugs for Treatment Use, 64 Food & Drug L.J. 183–224 (2009); Jerome Groopman, The Right to a Trial: Should Dying Patients Have Access to Experimental Drugs?, New Yorker, Dec. 18, 2006, http://www.newyorker.com/magazine/2006/12/18/the-right-to-a-trial [https://perma.cc/ZY56-Y6S8].

414 Mission Statement, Treatment Action Group, http://www.treatmentactiongroup.org/mission [https://perma.cc/CWF7-33DN].

415 H. Comm. on Rules, 114th Cong., Text of House Amendment to the Senate Amendment to H.R. 34, Tsunami Warning, Education and Research Act of 2015, (Comm. Print 114-67) (“showing the text of the 21st Century Cures Act”). Over 250 patient groups joined industry in supporting the initial version of the bill in 2015. Letter from 251 Patient Orgs to Leadership of House Comm. on Energy and Commerce (June 18, 2015), http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Letters/251PatientGroupsSupportCures.pdf [https://perma.cc/43J6-BTWM].

416 Twenty-First Century Cures Act, Pub. L. No. 114-255, § 1001 (2016). This funding was an important reason why the law attracted the support of many Democrats skeptical about its other provisions.

417 Id. at § 3002.

418 Id. at § 3022.

419 Id. at § 3032.

420 Gregg Gonsalves, Mark Harrington, & David A. Kessler, Don't Weaken the F.D.A.'s Drug Approval Process, N.Y. Times, June 11, 2015, http://www.nytimes.com/2015/06/11/opinion/dont-weaken-the-fdas-drug-approval-process.html.

421 For example, the “real world evidence” section clearly states that it does not alter the current standard of evidence for drug approval, “including the substantial evidence standard” in section 505(d) of the FDCA. Twenty-First Century Cures Act, § 3022.

422 Thomas M. Burton, White House Backs Drug Law for Terminally Ill Patients, Wall St. J., Feb. 8, 2017, at A3; Right to try Model Legislation, Goldwater Inst., http://scienceblogs.com/insolence/files/2014/10/GoldwaterInstituteRighttoTryModel.pdf [https://perma.cc/9SVA-27RJ]. See also Rebecca, Dresser, The “Right to Try” Investigational Drugs: Science and Stories in the Access Debate, 93 Tex. L. Rev. 1631 (2015)Google Scholar; Paul Howard, Hail Mary Medicine, Wall St. J., Nov. 13, 2015, http://www.wsj.com/articles/hail-mary-medicine-1447375941 [https://perma.cc/5Y4J-5JZH].

423 Some of the laws would also immunize physicians and drug companies from tort liability.

424 Alexander, Hertel-Fernandez, Who Passes Business's “Model Bills”? Policy Capacity and Corporate Influence in U.S. State Politics, 12 Persps. on Pol. 582, 583, 584 (2014)Google Scholar. On the Goldwater Institute's links to ALEC, see Center for Media and Democracy & Arizona Working Families, A Reporter's Guide to the Goldwater Institute: What Citizens, Policymakers, and Reporters Should Know (Mar. 14, 2013).

425 Ariz. Sec'y of State, State of Ariz. Official Canvass: 2014 Gen. Election 13 (2014), http://apps.azsos.gov/election/2014/general/canvass2014GE.pdf [https://perma.cc/HE2C-TZDZ].

426 Matthew Perrone, Former FDA Foe Now is in Its Corner, Bos. Globe, Aug. 12, 2014, at B7.

427 Gregg Gonsalves, Letter to the Editor, Going Around FDA Will Not Serve Patients' Interests, WASH. POST, May 21, 2014, at A14.

428 Such bills have periodically appeared—and failed—since the mid-1990s. See, e.g., Terminally Ill Access to Treatment Act of 1996, H.R. 3149, 104th Cong. (1996); Compassionate Freedom of Choice Act of 2012, H.R. 6342, 112th Cong. (2012); Right to Try Act of 2015, H.R. 3012, 114th Cong. (2015).

429 Thomas M. Burton, White House Backs Drug Law for Terminally Ill Patients, Wall St. J., Feb. 8, 2017, at A3.

430 Trickett Wendler Right to Try Act of 2017, S. 204, 115th Cong. (2017) (introduced Jan. 24, 2017); Right to Try Act of 2017, H.R. 878, 115th Cong. (2017) (introduced Feb. 6, 2017).

431 The state “right to try” measures generally mandate that the drug in question “remain under investigation in a clinical trial,” but this requirement falls well short of ensuring that drug sponsors are vigorously pursuing a complete clinical research program and ultimate FDA approval.