Don’t limit the powers of the FDA

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tags: FDA



Alison Bateman-House is an assistant professor of medical ethics at NYU School of Medicine. Ameet Sarpatwari is an instructor in medicine and assistant director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital and Harvard Medical School.

Repeated scandals helped create the Food and Drug Administration we know today: a thriving agency that effectively protects consumers and patients from unsafe food and drugs. However, Congress is overdue in passing legislation necessary to keep the FDA running, with one senator threatening further delay to force adoption of a policy that limits the powers of the agency. It is important that we remember the lessons of history and preserve the tools the FDA needs for its vital mission. 

In the 19th century, Congress granted the Customs Service and Department of Agriculture limited powers to protect Americans from adulterated drugs. However, it was not until public exposure by muckrakers of egregious industry practices in the 1900s that more comprehensive legislation was passed. Signed by President Theodore Roosevelt in 1906, the Pure Food and Drug Act prohibited the introduction of adulterated or misbranded drugs in interstate commerce but did not require premarket testing. It took the death of 107 people — many of them children — from the poison-containing elixir sulfanilamide, to remedy this shortcoming. The resulting outcry facilitated enactment of the Federal Food, Drug, and Cosmetic Act in 1938, which mandated that manufacturers demonstrate the safety of drugs prior to FDA approval. In 1962, the Kefauver-Harris Amendments strengthened the protections of the FDCA, requiring premarket proof of efficacy in addition to safety. Again, the impetus for reform was tragedy: birth defects caused by the drug thalidomide.

While the creation of the modern FDA is thus a story of consumer protection, the regulatory narrative changed with the emergence of AIDS in the 1980s. In the face of a seeming death sentence, patient-activists clamored for the opportunity to try investigational medicines of unknown safety and efficacy. They argued that the drug approval process was too slow and wanted to avail themselves of any chance, no matter how slight, of not dying from the disease. 

In response to this pressure, the FDA formalized a process for patients with serious or life-threatening conditions to access investigational drugs. To allow such “expanded access” requests, the FDA must determine that no similar therapies are already on the market, that access will not interfere with ongoing clinical trials, and that the benefits of access justify the potential harms. The FDA approves the overwhelming majority of expanded access requests it receives. ...




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