Light Shed on Politicized FDA

 

 

The New York Times is reporting that the Food and Drug Administration was influenced by four New Jersey congressmen and the FDA’s own former commissioner to approve a patch for injured knees. Those investigating and making the claim are the FDA’s own scientific reviewers. The patch device is the Menaflex and manufactured by ReGen Biologics Inc., a Hackensack, New Jersey based company. The approval is now under review by agency scientists.

Menaflex is used to repair the meniscus when it is damaged. The meniscus is the cushion-like part between knee bones. At least 30 people in the US and 3000 in Europe have received the Menaflex, and ReGen reportedly has trained 140 surgeons in the US to use the device. However, clinical studies have shown Menaflex to be no more successful than routine surgery. ReGen executives dispute this.

This is more a story of how the device was approved than its actual performance. It hasn’t yet been recalled, and who knows if it ever will; so far it hasn’t performed badly. In fact, patients who have already received the device have been told not to panic and await the outcome of the investigation.

However, the way in which a company can call its local politicians to get a federal agency to okay a product that hasn’t been proven to be successful certainly should be alarming to all of us. It makes one wonder how many products are only out there because of political pressure.

The Political Process

The four New Jersey congressmen were all given money by ReGen. These have been described as “donations” by several organizations, but these donations may also be seen as a bribe if what the Times says is true. All four senators believe they were simply helping constituents, while former FDA commissioner Dr. Andrew von Eschenbach says he acted appropriately.

Others question the integrity of Dr. Eschenbach and the congressmen. While the American people may have grown just cynical enough to expect this type of behavior from politicians, we also expect scientists to remain politically neutral and look at the facts. Still, other aspects have come to light regarding this story.

The agency has asked the Institute of Medicine to review the entire process in how medical devices are approved. The agency claims that for decades, most medical devices receive only a cursory review of their safety and effectiveness. This in itself is a little disconcerting. The agency has also said the device was approved since it was supposed to be similar to an earlier device that approved because – again – it was supposed to be like an earlier approved device. This is was the agency report on the matter called “predicate creep.” This is when devices are approved based on information gleaned from other devices that are not necessarily similar to one another.

This is also the first time the agency has publicly questioned its own process, admitted the regulatory decision was political in nature, and has certainly never publicly accused a former commissioner of acting with questionable conduct.