The New York Times reports that the Food and Drug Administration has revealed that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting. The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.
But after receiving what an FDA report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.
All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner (who resigned amidst controversy in August 2009), said he had acted properly.
As noted in the wake of previous similar problems, this highlights the importance of passage of the Medical Device Safety Act, which would restore the right of patients injured by faulty medical devices to hold manufacturers accountable. The safety of millions of Americans with medical devices should not be put in the hands of one person at the FDA. The civil justice system provides an independent check and balance on corporations to ensure that their products are safe.
Tags: corruption, FDA, mdsa
[...] noted in our Medtronic heart lead recall blog, the New York Times has issued a story that the U.S. FDA “has revealed that four New Jersey [...]