Political pressure is nothing new for the US Food and Drug Administration. The agency has frequently come under fire for its drug approval decisions, but attacks on its decision-making process and science itself have increased during the Covid-19 pandemic.
I am a legal scholar whose research focuses in part on the law and ethics of the FDA’s drug approval process. Examining the FDA’s history reveals the unprecedented nature of the current challenges to the agency’s authority.In its early years, the FDA focused primarily on balancing the competing goals of consumer safety with access to experimental treatments. The priority was strengthening consumer protection to prevent tragedy from recurring.
Similarly, in 1937, approximately 71 adults and 34 children died from ingesting S.E. Massengill’s antibacterial elixir, which contained a poisonous raspberry flavoring added to sweeten the taste. In response, Congress passed the Federal Food, Drug and Cosmetic Act of 1938, requiring manufacturers to show that drugs are safe before they go on the market. This act marked the beginning of modern drug regulations and the birth of the FDA as a regulatory agency.
After massive protests, Dr. Anthony Fauci, then director of the National Institute of Allergy and Infectious Diseases, proposed a parallel track program allowing eligible patients access to unapproved experimental treatments. This, along with other existing FDA mechanisms, helped lay the path for other alternative approval pathways, such as Emergency Use Authorization, which played a large role in permitting use of vaccines and medications pending full FDA approval during the Covid-19 pandemic.