The FDA and Safety Risks

When the Trump administration took office in 2025, the U.S. Food and Drug Administration, like other federal agencies, faced budget cuts, staff layoffs, and initiatives aimed at deregulation — the FDA was being reshaped. We asked Rachel Washburn, whose expertise includes science, technology, and medicine studies, to review the agency’s origin, history, and controversies. —The Editor

When was the FDA established?

The roots of the FDA date back to the 19th century, when the Department of Agriculture established the Bureau of Chemistry to carry out studies on food and drug safety with an emphasis on mislabeling and preservatives and other adulterants. In the early 20th century, the bureau’s scientific purview was broadened to regulatory authority over food and drugs, including pesticide residues found on fruits and vegetables at market. Since then, the bureau has been renamed several times and placed under differing federal agencies. In 1980, it was moved to the Department of Health and Human Services, which is currently led by Robert F. Kennedy Jr.

What is the extent of the FDA’s purview today?

The agency divides its scope into eight areas including foods (food additives, bottled water, infant formula), drugs (prescription and over the counter), biologics (vaccines, blood and tissue products, allergenics), medical devices, electronic products that emit radiation (sunlamps, microwaves, x-ray equipment), cosmetics, tobacco products, and veterinary drugs. The FDA is also responsible for research in all these areas. 

What are some of the FDA’s significant accomplishments?

Some areas where the FDA has made a difference include developing standards for food and drug safety and labeling, overseeing the process of drug approval, and making sure that medical devices and vaccines are safe. In all these areas, the FDA has also sustained critiques for regulations that are either too stringent or too lax. It is important to remember the environment in which the FDA emerged: In the late 19th and early 20th centuries, there was far less research on the safety of foods and drugs and few regulations ensuring that what we ingested was indeed safe. There is still more we can do to keep ensuring safety, but we have come a very long way.

What role did the AIDS crisis have in leading to reforms of FDA approval processes? 

The FDA came under sustained attack during the late 1980s, especially from AIDS activists, for failing to approve drugs to treat the disease. By then, years into the epidemic, there was only one FDA-approved drug on the market, an antiretroviral called zidovudine (AZT). But other promising drugs were still considered by the FDA to be too experimental to be dispensed. Frustrated by the situation, underground clinics were set up by activists to import drugs from other countries, and the AIDS Coalition to Unleash Power (ACT UP) staged demonstrations around the country to raise awareness about the issue. AIDS activists became experts in the FDA drug-approval process and worked to establish credibility with scientists and the broader public. In October 1988, ACT UP members demonstrated at FDA headquarters, demanding access to drugs. Within a week, the FDA developed a new expedited process for approving drugs to treat HIV/AIDS and other life-threatening illnesses. The FDA now has four programs to expedite the development and review of drugs for life-threatening and serious conditions that otherwise lack treatment.  

What are some risks of weakening the FDA’s regulatory powers or significantly defunding it?

Like all major federal agencies charged with protecting public health, the FDA needs adequate funding to keep producing the evidence base needed to craft good regulations. Eroding the FDA’s regulatory powers means that private companies will have even more power to act in their own best interests. In turn, individuals may feel that they need to take more responsibility for ensuring their own health. This is a real problem, because we know that not everyone has the same access to information and, more importantly, the same ability to act on that information. We already have some significant health inequalities in this country. Any effort to pull back on federal responsibility for protecting health means that these inequalities will grow.