The FDA released a report yesterday stating that the agency and its former commissioner, Dr. Andew C. von Eschenbach, succumbed to pressure by four New Jersey congressmen in approving a collagen implant patch for injured knees last year. That approval is now being re-visited and re-analyzed.
Apparently FDA scientific reviewers had declined approval for the Menaflex device manufactured by ReGen Biologics, Inc. for years citing its high failure rate. The decisions against approval had been unanimous – that is until four New Jersey congressmen – Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr and Steve Rothman – stepped in to assert their influence on behalf of the New Jersey-based manufacturer. Not surprising, all four legislators received significant campaign contributions from ReGen.
It is sad and scary to think that manufacturers can literally buy approval of their product and an agency as important as the FDA can give it to pressure by politicians and ignore their own scientists. This is yet another example of the FDA failing the American public. We think that if a pharmaceutical drug or medical device has FDA approval, then the product and drug has passed all types of stringent safety testing. It just isn’t so. And the manufacturers want to hide behind this veil of "FDA approval" and take your right to seek compensation from them should you be the unfortunate one injured by their product? The public simply shouldn’t stand for it.
Call your Congressman today and tell them to listen to you and not the manufacturers. Tell them to support the passage of the Medical Device Safety Act to protect the public from defective devices and hold manufacturers accountable.