American Journal of Law & Medicine

Aids Activists, FDA Regulation, and the Amendment of America's Drug Constitution

INTRODUCTION                                                 688    I. A MOVEMENT FOR FREEDOM OF CHOICE WITHIN ORTHODOX        MEDICINE                                              694   II. LEGAL FRAMEWORK OF FDA DRUG REGULATION                 695  III. THE REAGAN ADMINISTRATION AND THE TREATMENT IND        700   IV. AIDS ACTIVISTS JOIN THE FRAY                           704    V. TACTICAL AND IDEOLOGICAL CHALLENGES                    709       A. GETTING INSIDE THE AGENCY                           709       B."WITH FRIENDS LIKE THESE                             711       C. ARTICULATING AN IDEOLOGY OF LIBERTY                 713   VI. EARLY VICTORY: SUBPART E                               716  VII. THE ACTIVISTS TRIUMP: PARALLEL TRACK                   718       A. GENESIS OF AN IDEA                                  718       B. CONGRESSIONAL HEARING                               721       C. ADVISORY COMMITTEE MEETING                          722       D. THE POLICY                                          725 VIII. SCHISM: THE TREATMENT ACTIVISTS BREAK AWAY             726   IX. THE INTERNECINE BATTLE OVER ACCELERATED APPROVAL       727       A. BIRTH OF THE PROCEDURE                              727       B. TAG'S MISGIVINGS                                    729       C. ADVISORY COMMITTEE MEETING                          731  CONCLUSION: LEGACY                                          734 


The Parklawn Building, a massive, bland edifice erected in the late 1960s, looms over a neighborhood of nondescript office buildings and auto repair shops in Rockville, Maryland, about four miles outside the Washington, D.C. Beltway. Until recently, the building contained the headquarters of the U.S. Food and Drug Administration (FDA), as well as other Department of Health and Human Services (HHS) offices. It is an unlikely setting for a mass protest. For a thousand boisterous AIDS activists who stormed it on October 12, 1988, however, the Parklawn Building was the Bastille. (1) And as this Article will explain, their demonstration sparked a profound transformation in the government's approach to regulating treatments for serious illnesses.

The "Seize Control of FDA" protesters--many of them bused in by the recently formed AIDS Coalition to Unleash Power (ACT UP)--demanded that the agency speed the availability of drugs for Acquired Immune Deficiency Syndrome (AIDS). Since it had emerged in the United States in 1981, AIDS had spread with particular virulence among gay and bisexual men. (2) They dominated the crowd surrounding the Parklawn Building, although many women joined the protest, too. (3) For an entire workday, the demonstrators loudly condemned the federal government's inaction in the face of AIDS. They denounced the apathy of President Ronald Reagan and Vice President George H. W. Bush (the 1988 Republican presidential nominee). (4) Their primary target, however, was the FDA itself.

In truth, the FDA had not been completely inert in response to the horrific rise of the epidemic. In 1986, the agency had made azidothymidine (AZT)--an investigational antiretroviral drug that targeted the human immunodeficiency virus (HIV)--available to patients outside of formal clinical trials on a "compassionate use" basis. (5) The following year, it had approved AZT's New Drug Application (NDA) with extraordinary speed. (6) In addition, the FDA had issued a "treatment IND" rule in 1987, formalizing its longstanding ad hoc practice of allowing therapeutic use of investigational new drugs in desperate situations. (7)

AIDS activists were nonetheless enraged in the fall of 1988. AZT remained the only FDA-approved therapy for HIV/AIDS. (8) At best, this drug delayed the disease's inevitably fatal outcome, and many people with AIDS (PWAs) could not tolerate its severe side effects. In October 1987, an FDA advisory committee had recommended against the approval of ganciclovir, a promising drug for a blindness-inducing eye infection common among PWAs. (9) Meanwhile, the treatment IND process was not significantly increasing access to AIDS drugs still under investigation. At the time of the Parklawn protest, the FDA had made only one AIDS-related experimental therapy available pursuant to the new procedure--trimetrexate, a medicine for an often fatal form of pneumonia acquired by many PWAs. (10)

American scientists were studying scores of other compounds, and many in the HIV-positive population were eager to try each one as soon as it showed the slightest evidence of efficacy, rather than wait the seven to ten years the FDA ordinarily took to approve a drug." Accompanied by whistles and noisemakers, the crowd around the Parklawn Building chanted its demands for pharmaceutical access. "AZT is not enough, give us all the other stuff!" (12) "Release the drugs now!" (13) Most provocatively, the demonstrators, referring to the FDA Commissioner, yelled "Frank Young, you can't hide, we charge you with genocide!" (14) Their placards and banners were no gentler. "AIDS Doesn't Discriminate--Our Government Does." (15) "Federal Death Administration." (16) Many signs displayed a pink triangle, evoking the patch sewn onto the uniforms of gay inmates in Nazi concentration camps. (17)

The action's theatrical elements captured the attention of cameramen from the television networks and major newspapers. Protestors lay down on the street holding cardboard tombstones bearing epitaphs such as "RIP, Killed by FDA" and "I Died for the Sins of FDA." (18) Others paraded around in "blood"-stained white doctors' coats. (19) ACT UP's Peter Staley, a J. P. Morgan bond trader turned full-time activist, hoisted himself onto the portico over the building's main entrance, wearing a bandana that made him look, in the eyes of a fellow protestor, like the Karate Kid. (20) Once there, he attached a giant "Silence=Death" sign on the facade and set off smoke bombs, to the cheers of the throng. (21)

The event was peaceful overall. A glass door and a couple of windows were shattered. (22) Six activists snuck inside the building and briefly occupied some non-FDA offices. (23) One protester was arrested after knocking a police officer off his motorcycle. (24) Other demonstrators, some in T-shirts declaring "Gay and Positive," occupied the driveway in front of the building and refused to move. (25) Eventually, police--some wearing latex gloves--escorted or dragged 175 handcuffed activists to buses, which carted them off to be booked for loitering. (26) Despite the gravity of the cause, the event was characterized by inspired camp and an almost festive camaraderie. As the buses rolled away to transport the arrestees to the police station, the passengers crooned the theme song from television's Carol Burnett Show: "I'm so glad we had this time together." (27) One activist recalled, "It was really fun. I mean, it was really fun." (28)

The day of the protest was not a productive one inside the Parklawn Building. Many employees stayed home or failed to breach the blockade. (29) Those who managed to reach their desks spent hours peering through windows at the commotion outside.

When the workforce arrived en masse the next morning, things seemed back to normal. But in fact, the FDA never really resumed business as usual after ACT UP seized the agency in October 1988. This Article will examine how the AIDS social movement spurred changes in the agency's implementation of the Food, Drug, and Cosmetic Act (FDCA) and, eventually, in the language of the statute itself. The resulting reforms have made access to potentially life-saving drugs a fundamental goal of the Act, alongside the protection of consumers from unsafe and ineffective products. (30)

In describing and analyzing the AIDS activists' impact on FDA drug regulation, this Article draws on a number prominent contemporary developments in legal scholarship. One scholarly trend, articulated most prominently by William N. Eskridge and John Ferejohn, focuses on how this country's foundational legal principles are contained not only in the U.S. Constitution, but also in quasi-constitutional "superstatutes" and their implementation by administrative agencies. (31) The FDCA, enacted in 1938 as the successor to the Pure Food and Drugs Act of 1906, is one such statute. (32) Congress passed the FDCA largely in response to a crisis precipitated by insufficient government protection of drug consumers--namely, the death of more than a hundred people who consumed a medicine called Elixir Sulfanilamide. (33) The statute was premised on the principle that the national government should shield consumers from unsafe and (in the case of medical products) ineffective goods, including food, drugs, cosmetics, and medical devices. (34) Later amendments, in 1962 and 1976, strengthened the statute by requiring the FDA to block new drugs and some medical devices from entering the market until the agency was satisfied that their benefits outweighed their risks. (35) Despite occasional protests, the American public has broadly endorsed FDA's role as the gatekeeper for medical products. (36)

The quasi-constitutional nature of the FDCA is reflected not only in the important, deeply-entrenched government structures and functions it has created, but also in its corresponding effect of restricting American consumers' choices within some of the most essential product categories in the human economy. As a formal matter, the Act curbs the conduct of manufacturers and distributors, not their customers. Nevertheless, when the FDA prevents the sale of a product altogether, the Agency also indirectly limits the rights of consumers who want that product. Americans usually quietly accept this constraint on their freedom of choice because they value the FDA's role in safeguarding their health. On occasion, however--and with increasingly frequency since the 1970s--citizens have resisted FDA restrictions on the sale of certain drugs as unwarranted infringements on their autonomy. As we will see, these protests have been especially fervent with respect to potentially life-saving medications, as patients have condemned government curbs on the distribution of such products as violations of the most fundamental right of all--the right to attempt to preserve one's own life.

The AIDS activists' struggle to loosen the FDA's gatekeeping role with respect to drugs can thus be viewed as a form of constitutional struggle, even though they rarely invoked the language of the U.S. Constitution itself. By forcing a change in the FDA's regulatory practices, the campaign effectively amended the country's "drug constitution"--a term I use in this Article to refer to the human drug provisions of the FDCA and the agency's interpretation and application of them. Before the AIDS movement took to the streets, the FDA viewed the sole core purpose of the FDCA as guarding the public health by protecting consumers from hazardous and ineffective products. (37) As this Article describes, by the time AIDS activism waned in the early 1990s, the Act--as interpreted and applied by the agency--also embodied the (sometimes contrary) fundamental purpose of promoting the expeditious release of potentially effective treatments, both to advance public health and to enhance consumer choice. Before the turn of the century, Congress would embody this transformation in the language of the FDCA itself. (38)

This Article is also a contribution to the growing body of scholarship, dubbed "demosprudence" by Lani Guinier and Gerald Torres, that focuses on the "dynamic equilibrium of power between law and social movements." (39) Work in this vein considers how citizen mobilizations create the conditions for durable legal change, including by opening space for marginalized minorities to participate in policy formation. (40) This approach is becoming an important component of constitutional law scholarship in particular. While some of this work focuses on the influence social movements have on the judicial interpretation and application of the U.S. Constitution itself (what Eskridge and Ferejohn call "large 'C Constitutionalism"), (41) an important more recent strain emphasizes their impact on the language and post-enactment implementation of quasi-constitutional superstatutes ("small 'c' constitutionalism"). This Article contributes to this latter body of work, which examines how constitutional values are forged by interactions between social movements and nonjudicial government officials, such as agency administrators and legislators.

The story of the AIDS activists' struggle to reform FDA drug regulation thus demonstrates how extralegal popular mobilization can play an important constitutive function in the administrative law sphere. This Article is not the first work of legal scholarship to emphasize the importance of interactions between social movements and administrative agencies in shaping the nation's core values. (42) Such studies are a small but growing component of the growing body of work about "administrative constitutionalism." (43) Nevertheless, legal academics have produced few detailed analyses, from the ground-up, of the tactics particular social movements have used to shape particular agencies' policies. (44) This Article adds to the literature by providing such an examination. The AIDS movement's FDA campaign offers a particularly interesting example of a social movement's administrative reform effort, for the notice-and-comment rulemaking procedure established by the Administrative Procedure Act of 1946 (APA) (45) was far less crucial to it than other, non-APA techniques, such as street protests, media appearances, private meetings with agency officials, and testimony at public hearings.

This Article also offers insight into the distinct dynamic of social movement campaigns focusing on scientific agencies that deal with highly technical issues. In contrast to agencies like the Equal Employment Opportunity Commission (EEOC) (recently examined from a social movement perspective by Vicki Schultz (46)), the FDA bases its decisions largely on hard scientific data. Although some legal scholars have discussed social movements' efforts to reform the practices of scientific agencies, particularly in the environmental area, (47) close studies of the particular challenges confronting such efforts appear primarily in social science literature. (4) As I explore below, the scientific nature of the FDA's mission shaped the AIDS movement's activism, requiring the development of a cadre of technically sophisticated "treatment activists" who forged productive working relationships with government officials and scientists. This development in turn produced irresolvable tensions within the movement itself, and a bitter split ultimately occurred between these "insider" treatment activists and their less scientifically literate, more radical "outsider" counterparts.

Finally, this Article highlights two distinctive aspects of patient activism concerning the regulation of medical products. One distinguishing feature is the especially fraught intra-movement divisions rooted in the very nature of medical research. (49) Modern clinical science depends primarily on the double-blind controlled investigation--a methodology that treats ill people as randomly-assigned subjects of study rather than as autonomous patients. As we will see, AIDS activists were passionately divided on the morality of restricting patient choice in the interest of obtaining scientific evidence of efficacy.

This Article also explores an inter-movement phenomenon characteristic of medical product activism. The ideological dynamics of body politics can forge remarkable left-right coalitions. In the case of AIDS drugs, left-leaning champions of gay and women's liberation who supported government intervention in many arenas joined forces with right-leaning libertarians who promoted sweeping deregulation. As we will see, this alliance of convenience presented the AIDS movement with challenges as well as opportunities.

This Article will proceed as follows. Section I introduces the special problems AIDS activists confronted as the first major movement for freedom of therapeutic choice focused not on alternative cures but on orthodox medicine. Section II lays out the legal framework for drug regulation established by the FDCA. This section also describes the FDA's general approach to implementing this statute prior to the AIDS crisis. Section III describes how even before the rise of the AIDS movement, conservative libertarians fought, with limited success, to make unapproved drugs more available to PWAs and others with deadly diseases.

Section IV discusses the emergence of FDA-focused activism among PWAs and their allies, culminating in the Parklawn protest. Section V explores a variety of tactical and ideological questions faced by the AIDS movement following the FDA demonstration. Section VI considers the movement's initial regulatory victory, the publication of "Subpart E" procedures expediting the development of drugs for serious illnesses, and Section VII describes its greatest triumph, the creation of a "parallel track" allowing PWAs to take unapproved drugs for treatment purposes while clinical trials were still ongoing. Section VIII describes the schism that subsequently developed, dividing scientifically literate "treatment activists" from the broader movement. Section IX analyzes the vicious conflict that occurred between these factions over FDA's proposed "Accelerated Approval" procedure, which lowered the evidentiary requirements for initial marketing of some AIDS drugs. Finally, this Article's Conclusion considers the legacy of the AIDS movement's FDA campaign: the amendment of America's "drug constitution" in a way that still shapes medical product regulation today.


AIDS activism was not the first social movement to target the FDA; as I have examined in other work, movements fighting for access to dietary supplements and Laetrile (an alternative cancer treatment derived from apricot pits) had done so in the 1970s. (50) Nonetheless, something different was going on when ACT UP took up its struggle. Unlike their forerunners, the leading AIDS activists did not reject the scientific premises of modern drug development. To the contrary, they focused their demands on cutting-edge pharmaceutical treatments produced by the government-industrial-academic biomedical complex. (51) AIDS activism was the first mass movement for freedom of therapeutic choice within orthodox scientific medicine.

The AIDS movement thus invited a fundamental tension into its ideology--a tension that, more than anything else, distinguished it from prior campaigns for freedom of therapeutic choice. As I have described elsewhere, American opponents of government restrictions on alternative therapies have long stressed the value of unfettered experimentation by practitioners and patients. They have considered free inquiry to be essential to both effective individual treatment and to the advancement of medical knowledge. (52)

By contrast, in the worldview of modern scientific medicine, a treatment's efficacy is determined not by decentralized trial-and-error experimentation, but by meticulously designed, FDA-regulated, controlled clinical studies. Indeed, those who embrace the modern clinical research model believe that the unrestricted use of experimental drugs actually undermines the quest for scientific truth by diverting patients away from such controlled studies. The AIDS activists thus pinned their medical hopes on a system in which the advancement of knowledge requires not free inquiry, but rather highly regulated inquiry. As we will see, this tension between access and knowledge bedeviled the AIDS movement's campaign to reform FDA drug regulation and, ultimately, prevented it from ever coalescing around a unified, comprehensive medical libertarian ideology.

The fact that AIDS activism was a movement for freedom of therapeutic choice within orthodox medicine also impelled the AIDS community to embrace different tactics. Protesters against government curbs on alternative medicine have generally approached their tasks as outsiders. They have stood apart from, and resisted the authority of, establishment institutions and orthodox systems of knowledge. AIDS activists sometimes adopted an "outsider" approach, particularly when they engaged in disruptive direct actions, not only at the FDA, but also, for example, at the National Institutes of Health (NIH), St. Patrick's Cathedral, the New York Stock Exchange, the American Medical Association headquarters, and North Carolina Senator Jesse Helms's house (which they sheathed in a giant condom). (53) Such demonstrations called attention to PWAs' plight, challenged the homophobic values of the dominant culture, and satisfied the expressive and identity-building needs of the AIDS community itself.

But leading AIDS activists recognized that street protests alone could not achieve their more instrumental goal of reforming the FDA's approach to drug regulation. That mission, they concluded, required members of their movement to enter the halls of power and, using the technical language of modern scientific medicine, interact directly with the government, the pharmaceutical industry, and the clinical research community. Consequently, an organized group of "treatment activists" emerged within ACT UP to lead the FDA reform effort. (54) This determined coterie of eloquent laymen mastered the science of AIDS and the complexities of pharmaceutical research. Due to their emergence, the AIDS movement did not, like most social movements focused on science or medicine, simply attack the trustworthiness of "experts" or embrace an anti-scientific epistemology. Instead, as contemporaneously described by sociologist Steven Epstein:

These activists wrangle with scientists on issues of truth and method. They seek not only to reform science by exerting pressure from the outside but also to perform science by locating themselves on the inside.... Most fundamentally, they claim to speak credibly as experts in their own right--as people who know about things scientific and who can partake of this special and powerful discourse of truth. (55) 

In both formal proceedings and informal meetings, this cluster of autodidacts engaged in highly technical discussions with the FDA and other stakeholders about how best to tackle the AIDS crisis. This "inside" complement to outside action was perhaps the defining characteristic of AIDS activism and subsequent movements for freedom within orthodox medicine. (56) As we will see, however, it also represented a widening schism that ultimately tore the AIDS movement apart.


Although the FDA arguably lacked sensitivity, creativity, and a sufficient sense of urgency in its early response to AIDS, nobody could charge it with violating the law by severely restricting access to drugs not yet definitively shown to be safe and effective. To the contrary, the agency was following the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) to the letter. Unfortunately for PWAs clamoring for an opportunity to try new medications, that statute's primary goal was to keep unsafe and ineffective drugs off the market.

In 1938, Congress passed the FDCA largely in response to a catastrophe in more than a hundred Americans, many of them children, died as a result of taking "Elixir Sulfanilamide," an early antibiotic. (57) Before this time, the FDA lacked any power to review the safety of drugs prior to sale. The FDCA created the modern system under which submission of a New Drug Application (NDA) to the agency must precede the introduction of a new drug onto the market. (58) Notably, however, the 1938 version of the statute required NDAs to contain evidence of safety, but not of effectiveness. (59) Furthermore, the 1938 FDCA created a premarket notification process rather than a true premarket approval process; an NDA would automatically "become effective" after 60 days unless the FDA intervened and affirmatively disapproved it. (60)

The groundbreaking 1962 Drug Amendments were a reaction to another public health disaster. This time, the source of the problem was thalidomide, a popular sedative used in many nations around the world. (61) Soon after pregnant women began to take thalidomide as a treatment for morning sickness, it became apparent that the drug caused severe birth defects--most distinctively malformed and stunted limbs. (62) Thanks to the resoluteness of a now-legendary FDA medical officer named Frances Kelsey, the agency never allowed thalidomide's American NDA to become effective. Congress recognized how narrowly the United States had averted tragedy, however, and it promptly amended the FDCA to strengthen the regulation of new drugs--in ways that went far beyond correcting any deficiencies revealed by the thalidomide crisis. (63)

The main features of the regulatory framework established by the 1962 Drug Amendments remain intact today. The Amendments introduced the requirement that investigators notify the FDA prior to commencing any study of an unapproved drug in human beings. (64) Moreover, Congress authorized the agency to disallow or halt any investigation that did not satisfy requirements set forth in FDA regulations, including human subject protections. (65) The FDA issued these "Investigational New Drug" (IND) regulations in 1963. One section of this rule established the enduring three-phase structure for human drug experiments familiar to researchers today. (67) Phase 1 studies are performed in a small number of (usually healthy) volunteers and are designed primarily to assess the drug's safety at increasing doses. (68) Phase 2 studies are conducted in a larger but limited number of subjects suffering from the target disease and are performed with the goal of assessing the treatment's effectiveness as well as safety. (69) Phase 3 studies are large trials intended to gather all the information the FDA needs to perform an overall risk-benefit assessment of the drug and to review the proposed physician labeling.

The 1962 Amendments also made important changes to the FDA drug approval process. They converted the NDA procedure into a true premarket approval scheme, under which a manufacturer cannot legally market a new drug until the FDA has positively approved it. (71) More importantly, the 1962 Amendments revised the Act to require the agency to reject an NDA, not only if the applicant fails to demonstrate that the drug is safe, but also if "there is a lack of substantial evidence that the drug will have the effect it purports... to have... in the proposed labeling." (72)

Although the 1962 Amendments listed proof of safety and proof of effectiveness as separate requirements, the FDA immediately recognized the inextricable relationship between them and embraced a drug approval calculus that weighs benefit against risk. (73) This interpretation of the statute was sensible and probably inevitable. Many useful pharmaceutical products (including most AIDS and cancer drugs) pose significant risks. If FDA considered the safety of such products in isolation from their benefits, it would reject many indispensable treatments. But this risk-benefit approach also exposed the FDA to a new type of challenge to its NDA decisions--attacks on the agency's policy judgments rather than (or in addition to) its scientific findings. After all, a decision by the FDA to reject an effective drug because of excessive risks is not merely a scientific conclusion. Rather, it is a determination that the particular product's risks so clearly outweigh its benefits that the government should deny patients and their physicians the opportunity to perform their own risk-benefit assessment and make their own treatment decision. The AIDS activists were among the first to attack FDA rulings on this basis.

Another critical feature of the 1962 Amendments was their definition of "substantial evidence" of effectiveness: "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved." (74) Congress left the precise meaning of this phrase to FDA regulation. As the AIDS activists would later realize, the agency's interpretations and applications of this statutory standard were also policy judgments subject to challenge, particularly in the context of an inevitably fatal disease whose victims might not demand the same level of certainty as people suffering from less serious ailments.

The FDA has always interpreted the plural form of the word investigations in the definition of "substantial evidence" to signify that a drug sponsor must ordinarily present at least two adequate and well-controlled studies demonstrating efficacy. (75) In practice, the agency almost always demands that these two studies be phase 3 trials. (76) In construing the term adequate and well controlled investigations in its regulations implementing the 1962 Amendments, the agency embraced the methodology broadly adopted by the field of clinical pharmacology during the 1950s: the randomized, double-blind, controlled study. (77) The FDA's 1970 rule on "adequate and well-controlled studies"--as elaborated by subsequent agency practices and guidance documents--established this type of trial as the "gold standard" for demonstrating drug efficacy. (78) The rule declared: "Isolated case reports, random experience, and reports lacking the details which permit scientific evaluation will not be considered [in assessing efficacy]." (79)

Consequently, for the past half-century, almost all "pivotal" trials conducted to demonstrate drug efficacy in support of an NDA have shared certain characteristics. They are "controlled"--that is, they compare, according to predefined diagnostic criteria, a group of people taking the experimental drug to one or more distinct "control" groups. Ideally, the control group takes a placebo, although other types of controls sometimes suffice, including the "active treatment" controls used when "administration of a placebo would be contrary to the interest of the patient." (80) To minimize bias, the subjects are assigned to the experimental arm or the control arm of the study on a random basis ("randomization"), and both investigators and subjects are ignorant with respect to which arm of the study each subject is in ("double-blinding"). To ensure scientific integrity, drug investigations are conducted according to detailed, pre-established protocols, and only people who satisfy strict eligibility criteria are permitted to participate.

Because of the rigorous, multistep drug development and approval process that Congress and the FDA imposed on manufacturers starting in 1962, many drugs took significantly longer to reach the market in the United States than in other advanced nations. (81) During the quarter of a century following 1962, both the time that industry spent researching new drugs and the time FDA spent reviewing NDAs ballooned. (82) The average total interval that elapsed between the commencement of clinical research and final FDA approval grew from a little over four years in 1963 to more than ten years by 1990. (83) While scholars and policymakers debated the significance and causes of this "drug lag," PWAs feared that without a change in approach, the AIDS treatments they needed would not reach the market until years after they had perished. (84)

AIDS patients derived some solace from the FDA's March 1987 approval of AZT. The approval was based on the results of one successful phase 2 study, a placebo-controlled trial that the agency terminated early because of its strikingly positive data. (85) Only twenty-two months passed between the start of clinical trials and approval of the NDA--a process so fast that one agency official likened AZT to a "greased pig." (86) But AZT was not a cure. Moreover, it was intolerably toxic for many people at the prescribed dose. (87) PWAs desperately sought access to additional drugs, and they did not want to wait for FDA approval.

When the AIDS crisis arose, neither the FDCA nor FDA regulations explicitly allowed any use of unapproved drugs for the treatment of patients, as opposed to their administration for research purposes. (88) Nonetheless, the agency had for decades sometimes permitted seriously ill patients with no satisfactory alternatives to obtain experimental drugs for treatment. It had done so on a largely ad hoc basis, under various rubrics, including "single patient exceptions" and "compassionate use INDs." Moreover, since 1976, the National Cancer Institute, with FDA acquiescence, had furnished the most promising cancer therapies it was investigating ("Group C" drugs) to physicians prior to approval for treatment use. …

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