ACT UP Storms the FDA and Changes How Drugs Get Approved

On the morning of October 11, 1988, a federal office building in Rockville, Maryland, woke up surrounded. The Parklawn Building was not a monument. It was a long, flat block of government offices in the suburbs north of Washington, the kind of place where forms go to be stamped. Inside it sat the Food and Drug Administration, the agency that decided which medicines Americans were allowed to take. Outside it, by the time the commuters arrived, were more than a thousand people who had come from across the country to tell that agency it was killing them. They carried cardboard tombstones. They lay down in the driveway. They hung a banner that read "Seize Control of the FDA." Police in rubber gloves hauled protesters into buses, one at a time, for hours. And somewhere in the crowd were people who had spent the previous year reading clinical trial protocols at their kitchen tables, which is the detail that turned out to matter most.

In short: In 1988, AIDS activists shut down the FDA's headquarters for a day and demanded faster access to experimental drugs. The protest worked less because of the noise than because the activists had learned the science and the regulations well enough to propose specific changes. Accelerated approval, expanded access and patient voices inside drug review all trace part of their lineage to that morning, and the fight over how fast is too fast is still going.

A disease, a drug and a seven-year wait

By the fall of 1988, the epidemic was seven years old in the official record. The first report of what would be called AIDS appeared in June 1981. In those seven years, tens of thousands of Americans had died, most of them young, many of them gay men, drug users, Haitian immigrants and people with hemophilia. The federal response had been slow and often grudging. President Reagan did not give a major public address on AIDS until May 1987.

There was one approved treatment. AZT, a drug originally developed decades earlier as a possible cancer medicine, had been approved by the FDA in March 1987 after a trial showed it extended the lives of people with advanced disease. It was hard on the body, it did not work for long on its own, and at launch it was among the most expensive prescription drugs ever sold. For most people with HIV in 1988, the realistic menu was AZT or nothing.

Meanwhile, other compounds sat in the pipeline. Some looked promising in the lab. Getting them to patients meant passing through the standard sequence of clinical trials, the system built after the thalidomide disaster of the early 1960s to make sure drugs were proven safe and effective before they reached the public. That system had saved lives. It also moved at a pace set for a world in which the patient could afford to wait. People with AIDS in 1988 could not. Many would be dead before the trial that might help them finished enrolling.

That is the tension at the center of this story, and it is worth sitting with it, because neither side was simply wrong. A careful regulator protects people from drugs that do nothing or do harm. A dying patient has a different calculation about risk. The question ACT UP forced onto the table was who gets to make that calculation.

Who showed up in Rockville

ACT UP, the AIDS Coalition to Unleash Power, formed in New York in March 1987, after a speech by the writer Larry Kramer at the city's Lesbian and Gay Community Services Center. It ran on weekly meetings that were loud, democratic and frequently chaotic. It also had committees, and one of them, the Treatment and Data Committee, did something unusual for a protest movement. Its members sat down and taught themselves pharmacology.

They read the Federal Register. They read trial designs. They learned what a placebo arm was and why a dying man might refuse to be in one. They learned the difference between a Phase I safety study and a Phase III efficacy trial, and they learned which FDA divisions handled which drugs. Some had no science background at all; they had been waiters, writers, bond traders and art students. They came to know the regulatory machinery well enough to argue with the people who ran it.

The Rockville action was planned as a national event. Groups from many cities joined, organized into affinity groups that each took on a piece of the day: blocking a door, staging a die-in, holding signs. The demonstrators had a list of demands, not a mood. They wanted the FDA to speed up approval of promising drugs, to allow people with AIDS access to experimental treatments outside rigid trials, to stop relying on placebo-only control groups when patients were dying, and to include women, people of color and drug users in trials that had mostly enrolled white gay men.

The FDA closed for the day. That alone made the evening news. But the coverage and the arrests were the surface. What gave the protest its long tail was that the activists walked away from the barricades and into meetings, carrying paper.

The rules that moved

Here is where the history gets less cinematic and more consequential. The changes that followed did not arrive in a single dramatic decree. They came as a series of regulations, policies and new habits at the FDA and the National Institutes of Health, some of which had been in motion before Rockville and were sped up by the pressure.

The first was expanded access. In 1987, the FDA had formalized rules for "treatment INDs," a way to let patients with serious diseases get investigational drugs before approval when no good alternative existed. Activists pushed to make that pathway real and broad rather than a narrow exception. In 1989, Anthony Fauci, then the director of the National Institute of Allergy and Infectious Diseases, publicly backed a "parallel track" idea: while a drug was being studied in a controlled trial, people who could not enroll could still receive it under monitoring. The antiviral ddI was made available this way while it was still under study.

The second was accelerated approval. In December 1992, the FDA finalized a rule allowing drugs for serious or life-threatening conditions to be approved based on a "surrogate endpoint," a lab marker reasonably likely to predict real clinical benefit, rather than waiting years to measure deaths prevented. The company would then have to run confirmatory studies after approval. For HIV, surrogate markers like counts of CD4 immune cells and, later, viral load let regulators move faster.

The third was cultural. Patient representatives began sitting on FDA advisory committees. Activists from ACT UP's treatment committee, and later the Treatment Action Group that grew out of it in 1992, were invited into NIH trial planning. The people who had been chained to the Parklawn Building's doors were helping to design studies a few years later. It is hard to find a cleaner example of a protest movement converting outside pressure into inside expertise.

Also in 1992, Congress passed the Prescription Drug User Fee Act, which let the FDA collect fees from drug companies to pay for more reviewers and set deadlines for review. That law had many parents, including the industry, but it fit the same demand: reviews should not take as long as they had been taking.

The payoff for people with HIV came in the mid-1990s. Protease inhibitors arrived in 1995 and 1996, approved quickly under the new expectations, and combination therapy changed AIDS from a near-certain death sentence into a manageable condition for those who could get treatment. Death rates in the United States fell sharply within a few years. No single protest produced that science, but the faster path to patients was in place when the science was ready.

The strongest case against speed

A fair account has to stop here and give the other side its due, because the argument ACT UP won has a cost that critics have been documenting ever since.

The case goes like this. A surrogate endpoint is a bet. A drug can shrink a tumor or lower a lab marker without helping people live longer or better, and sometimes a drug that improves a marker turns out to hurt patients in ways the marker missed. Once a drug is on the market under accelerated approval, the confirmatory trial is harder to run, because patients can simply get the drug instead of enrolling. For years, some companies were slow to finish those studies, and the FDA's tools for pulling a drug that failed to prove itself were clumsy.

The sharpest recent example came in 2021, when the FDA granted accelerated approval to the Alzheimer's drug Aduhelm based on its ability to reduce amyloid plaques in the brain, over the objections of its own outside advisory committee. Several committee members resigned. The drug's clinical benefit was disputed, its price was high, and its maker later discontinued it. Critics said the episode showed what happens when the urgency of 1988 is applied without the discipline that HIV researchers paired with it.

That criticism deserves a real answer, and the answer is not that speed is always good. The honest version is narrower. AIDS activists did not argue that evidence did not matter. They argued that the people bearing the risk should help set the trade-off, that trials should be designed around patients' lives, and that surrogate markers could be good science when validated. The HIV experience worked partly because viral load turned out to be an excellent predictor of outcomes. The lesson is not "approve faster." It is "approve faster when the marker is sound, and finish the follow-up studies."

Congress took a step in that direction in late 2022, giving the FDA more power to require confirmatory trials to be under way at the time of approval and to withdraw drugs more quickly when they fail. Progressives who care about both access and safety should see that as the kind of repair a good system needs, not as a betrayal of the original fight.

What the activists understood about power

The deeper legacy of Rockville is not a specific regulation. It is a method.

The activists combined three things that movements often treat as separate. They had a disruptive outside game: shutting down a federal agency for a day is not polite. They had a technical inside game: they could sit across from an FDA division director and argue about statistical power. And they had a moral frame that the public could understand without reading a single protocol, which was that people were dying while paperwork moved.

Most campaigns pick one. A purely disruptive movement can win attention and lose the follow-through, because it has no one who can say exactly what the rule should be. A purely technical movement can write beautiful comment letters that no one reads, because there is no pressure making anyone read them. ACT UP made the officials need to talk to them and then had something worth saying once they were in the room.

There is a lesson here for progressives that is uncomfortable. Plenty of current campaigns have the outrage and not the expertise, or the expertise and no one willing to make noise. The AIDS movement also had internal fights that were bitter, including over whether the treatment activists had become too cozy with the agencies. Those arguments were real and should not be smoothed over. But the combination of pressure and precision is what changed federal drug policy, and it is a model any movement can study.

From AZT to a twice-yearly shot

The science has traveled a long way since the Parklawn Building. Today a person diagnosed with HIV in the United States who gets steady treatment can expect a near-normal lifespan, and people whose virus is suppressed to undetectable levels do not transmit it sexually. Pre-exposure prophylaxis, or PrEP, was approved in 2012 as a daily pill to prevent infection. In June 2025, the FDA approved lenacapavir as an injection for prevention given twice a year, a tool that could reach people who struggle with a daily pill.

But the access fight that began in 1988 has not ended; it has moved. The new obstacles are price, insurance coverage and public health funding rather than the speed of review. In 2025, the Supreme Court decided Kennedy v. Braidwood Management, a challenge to the Affordable Care Act's rule that insurers cover recommended preventive services, including PrEP, at no cost. The Court upheld the structure of the task force that makes those recommendations, so the coverage requirement survived, but the case made plain how much depends on decisions made by appointed officials. In 2025, staff cuts at the Department of Health and Human Services also reached offices that work on HIV prevention, and advocates warned about the effect on testing and outreach.

A drug that works but costs too much, or that clinics cannot afford to offer, is an approval on paper. The activists of 1988 would recognize that problem at once. They would also recognize that the people with the most at stake, in the rural South where new HIV diagnoses are concentrated, among young Black and Latino gay and bisexual men, among people without stable insurance, are again the ones least likely to be in the room where coverage and funding decisions are made.

What you can do

The method from Rockville still works: learn the rule, then make the people who write it hear you. A few ways to start.

• Read and answer the rules that set health coverage. Proposed federal rules on Medicaid, the ACA marketplaces and drug pricing come up for public comment regularly. The comment page lists the federal rules open right now, closing soonest first and grouped by issue, with guidance on writing a comment that an agency has to log and consider. A comment that cites your own experience with a prescription or a clinic is worth more than a form letter.
• Call the people who fund HIV programs. Prevention and treatment money moves through annual appropriations. Use your representatives' page to find your House member, senators and state legislators, along with their phone numbers and their latest votes, and ask specifically where they stand on HIV prevention and Ryan White program funding.
• Back the groups doing the slow work. Local AIDS service organizations, LGBTQ+ health centers and legal aid groups handle the insurance appeals and the outreach that no regulation covers. The organizations directory lists nonprofits by cause in every state, including health and LGBTQ+ groups.
• Follow the broader fight. The coverage questions that began with AIDS now touch everyone with a chronic illness. Our pages on health care for all and LGBTQ+ rights gather the reporting as it happens.

The people outside the FDA in 1988 did not have money, votes in Congress or friends in the agency. They had a deadline nobody else could see and the patience to read the fine print. That turned out to be enough to change how the country approves medicine.