In the 1980s, as the death toll from HIV-AIDS mounted without any effective treatments, the Food and Drug Administration (FDA) denied most AIDS patients access to experimental drugs. Through strategic civil disobedience, AIDS activists including the AIDS Coalition to Unleash Power (ACT UP) launched arguably the most effective campaign ever against federal restrictions on the right to self‐medicate.
In 1988, protesters staged a “Seize Control of the FDA” demonstration in front of FDA headquarters. They carried somber, hard‐hitting signs reading, “R.I.P Killed by the FDA”. Protesters chanted, “42,000 dead from AIDS! Where is the FDA?”
Former FDA commissioner David Kessler credits ACT UP for changing the course of the AIDS epidemic. The protest gave voice to the frustrations of people who for years had watched their loved ones die while the FDA denied them access to drugs that could have extended their lives. But it was also a strategic political move. ACT UP purposefully had speakers from different states prepared to speak, thus the protest appeared in newspapers across the country. The protest shifted the blame for the crisis from the gay and trans community to a government agency that seemed to be twiddling its fingers while thousands died. The protestors were holding the FDA responsible and would not let the FDA continue to stifle the right to self‐medicate under the guise of “consumer protection.”
The movement impacted more than those living with AIDS. It challenged the FDA’s moral authority, changed public opinion, and led to changes that partially restored the freedom of individuals to access the medicines they want. For decades, the FDA assumed the role of protecting Americans from unsafe drugs, even if that meant delaying access to effective treatments. Former FDA Chief Counsel Richard Merrill described the purpose of the FDA as an agency meant “to prevent harm to consumers rather than facilitate the introduction of useful new products.”
Although risks may exist, it is often equally possible that the treatment may do more good than harm….
The question should be, “Who gets to decide what risks are acceptable: the bureaucracy in Washington or the patient whose life is on the line?”
These arguments changed political opinion. In 1979, a national poll showed 60 percent of respondents strongly agreed that a drug “should not be available until it is known to be completely safe and effective.” By 1989, however, 79 percent of respondents believed “the government should allow people with AIDS to be treated with drugs that had not been fully tested and approved.”
What started as an act of civil disobedience led to legal and cultural changes. A little more than a week after the “Seize Control of the FDA” demonstration, the FDA issued a rule promising faster approval of HIV-AIDS drugs. In the following years, the FDA would work side by side with AIDS activists to shape policies to allow patients broader and faster access to investigational new drugs. These initiatives included a “Parallel Track“ that allowed doctors to prescribe investigational new drugs to HIV and AIDS patients outside of clinical trials. The creation of Accelerated Approval allowed the FDA to approve drugs based on surrogate clinical endpoints. Instead of clinical trials having to prove survival new HIV/AIDS drugs only needed to prove “reasonably likely…to predict clinical benefits.” Eight months after the FDA established accelerated approval, post‐approval studies later showed people treated with zalcitabine and AZT plus had a 32 percent lower mortality rate. The Food and Drug Administration Modernization Act, the “Right to Try” Act, and needle exchanges, are legacies of the “Seize Control of the FDA” protest. They are examples of the ripple effects of effective civil disobedience.
In a new study, authors Michael F. Cannon and Jeffrey Singer argue that, much like premarket approval requirements denied AIDS patients access to necessary medicines, government‐imposed prescription requirements are blocking access to essential medicines that the FDA has already approved. They use the example of naloxone, a safe and life‐saving drug that has reversed more than 26,000 opioid overdoses. The FDA requires a prescription to purchase naloxone, a requirement that results in avoidable deaths. Cannon and Singer call for eliminating the FDA’s power to impose mandatory prescription requirements. They emphasize that not only do such requirements “prevent consumers from exercising their right to self‐medicate” but also leave consumers less safe rather than more.
As the organization People with AIDS wrote in The Denver Principles in 1983, individuals have the right “to choose or refuse their treatment modalities.” The FDA’s premarket approval and prescription requirements deny patients the right to make their own medical decisions. The fight for patients’ rights is ongoing.