Product News and Recalls

Who Exactly Does the FDA Serve?

fda under fire for not serving the american peopleIt’s no secret to anyone who has read this blog for any length of time that we have no difficulty with criticizing the Food and Drug Administration. It is a broken agency that is plagued by policies that seem written almost to invite corruption rather than make it less likely. As a personal injury law firm who has spent decades taking on the pharmaceutical industry and those who would allow dangerous products to reach the marketplace of the American people, you should expect no less from us.

It would seem, however, that we are far from the only party critical of the FDA, and that their problems only start with the legal community. The medical community has grown critical of the agency as well. The latest evidence of that claim can be found in a June 16th opinion piece on MedPage Today by Vinay Prasad, MD, MPH. In an article titled “The FDA is Failing the American People,” Dr. Prasad takes the FDA to task over a host of failures but pays particular attention to the FDA’s recent approval of Alzheimer’s drug aducanumab.

Aducanumab has been controversial since day one. At a cost of $56,000 per year per patient its price tag demands nothing but complete effectiveness. Yet, clinical data seems to show no significant increase in the quality of life for those patients taking the drug. It also comes with a laundry list of side effects.

The agency’s approval of the drug caused three members of the Peripheral and Central Nervous System Drugs Advisory Committee to resign their seats on the panel in protest. One of them called the drug “problematic,” which is not something one likes to hear when its staggering price tag means that if just one-third of Medicare eligible patients were to start taking it, costs for the program would jump $112 billion per year – just from aducanumab prescriptions alone.

Sadly, it’s not hard to reach the conclusion that it is the drug’s price tag which led to the agency’s approval of it in the first place. As one of the most transparently corrupt agencies in Washington, D.C., the FDA’s revolving door of former industry executives serving on influential federal committees is one of the worst kept secrets in the nation’s capital. There’s no other way to explain away some of its prior decisions. The approval of a $56,000 a year drug that serves almost no purpose is just the latest link in that chain.