However, the drug’s manufacturer, ReGen, which is based in Hackensack, N.J., gave four New Jersey congressmen a total of $26,000, which was followed by calls from the members of Congress to the FDA complaining about its review of the device. The congressmen all say they acted appropriately.
The FDA is now acknowledging that its former commissioner gave in to the pressure from ReGen, and began calling for an expedited approval process for the device, which was eventually approved in December 2008.
On Wednesday, the FDA asked the Institute of Medicine, a non-profit medical guidance and analysis organization, to review its procedures for approving drugs and medical devices. The Institute’s report was extremely critical.
This case strikes a chord with many other recent FDA cases in the past that GAP has been involved with. Although not directly involving congressmen, GAP client Dr. Victoria Hampshire was subjected to a smear campaign, aimed at discrediting her, by drug behemoth Wyeth Pharmaceuticals with the help of FDA senior officials. Why? Because Hampshire was assigned to review one of Wyeth’s profitable animal care products, and recommended it be taken off the market, after she found it had killed over 500 canines.