ACT UP's protest at the FDA

The activist Larry Kramer founded ACT UP, the AIDS Coalition to Unleash Power, in New York in March 1987 as a direct-action group. At its first protest, on Wall Street on 24 March, members demanded that the FDA release promising investigational drugs to everyone with AIDS or AIDS-related complex, that government-funded double-blind studies end and that drugs be priced affordably. Five days earlier the FDA had issued rules widening access to unapproved drugs, and in July 1988 it allowed people with life-threatening illnesses to import small quantities of unapproved drugs.

On 11 October 1988 more than 1,000 ACT UP members and supporters staged a sit-in at the FDA's offices in Rockville, Maryland, against the pace of approval of treatments for HIV and AIDS. The offices were shut for the whole day, and there were 176 arrests.

Eight days later the FDA announced new regulations, published on 21 October as subpart E of its investigational drug rules. For drugs meant to treat life-threatening and severely debilitating illnesses, especially where no satisfactory alternative existed, the agency said it would use the broadest flexibility in applying the legal standards of safety and effectiveness. It stated that physicians and patients facing such illnesses are generally willing to accept greater risks or side effects. Sponsors could consult FDA reviewers early, and after phase 1 testing the two sides were to agree on phase 2 controlled trials designed to support a decision on approval.

ACT UP's Treatment Action Committee kept confronting FDA and National Institutes of Health officials. Tasleem Padamsee, in a 2020 history of US HIV policy, credits these confrontations with regulatory changes that widened access to experimental treatments and cut approval times by two or more years, and with placing patient representatives and lay experts on federal decision-making bodies. The committee later became the independent Treatment Action Group. In 1992 the FDA adopted accelerated approval, which allows drugs for serious conditions with unmet needs to be approved on a surrogate endpoint.