Posts Tagged: ReGen Biologics


Andrew von Eschenbach, the last Bush administration Food and Drug Agency Commissioner, and four New Jersey members of Congress inappropriately pressured FDA scientists to approve a patch for injured knees back in December, reports the New York Times’ Gardiner Harris and David M. Halfbinger. Here’s the good news: the FDA internally blew the whistle on this and is pulling the knee patch off the market. The Times reports that FDA has “never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.” FDA has also let the Institute of Medicine review the entire process by which it approve medical devices.

In other words, the Obama FDA is correcting problems that took place in the Bush FDA. The Times piece focuses most on the quid pro-quo of the N.J. lawmakers who got money from ReGen Biologics and then pushed FDA to approve ReGen’s knee-patch. But the most unsettling and mysterious part is why Andrew von Eschenbach — in the twilight of his beleaguered tenure — pushed for approval. Ten months after the Bush administration, here is another example of a Bush federal agency head acting against the very mission of his agency.