As the federal agency charged with ensuring the safety of the nation’s pharmaceuticals, medical devices, food supply and a multitude of other products, the F.D.A., plays a pivotal role in American society. When a pharmaceutical company wants to bring to market a new drug, it’s the F.D.A. that has to sign off first. The same goes for medical devices like pacemakers and food products like vitamin supplements.
The F.D.A. derives its authority from the Federal Food, Drug and Cosmetic act, enacted by Congress in 1938 in the wake of Elixir Sulfanilamide disaster. The agency has one of the broadest mandates of any federal organization, responsible for the oversight of everything from prosthetic limbs to Tylenol.
These shortcomings are particularly apparent when it comes to medical devices. A 2011 study found that between 2005 and 2009, 113 devices were recalled for posing a serious health risk to patients, yet the vast majority of these were approved without undergoing thorough testing because the agency deemed them similar enough to other products already on the market. In particular, the agency is currently under fire for what’s widely perceived as an inadequate safety alert regarding potentially counterfeit surgical mesh used in implants manufactured by Boston Scientific. Mostyn Law, the firm currently litigating thousands of mesh cases against Boston Scientific, stated:
“The FDA’s watered-down warning of the risk posed by Boston Scientific’s surgical mesh falls far short of what is needed to protect women’s health. We are talking about a counterfeit version of a product that the original U.S. manufacturer has repeatedly said should not be used in the human body.”
A full listing of recalled products under the F.D.A.’s regulatory authority can be found here.
A New York Times report found the agency does little to nothing to oversee the efficacy of products like dietary supplements and homeopathic medicines, even though these products often boast F.D.A. endorsements. The agency also suffers from a number of glaring oversights, such as numerous medications that have been on the market for so long, the F.D.A. has simply never reviewed them thoroughly.
Fortunately, the F.D.A. is under increasing pressure to reform the way it reviews and oversees the products under its purview. With any luck, we can all look forward to a safer and more consistent regulatory environment in the near future.