Never before in the history of the Food and Drug Administration has it publicly questioned its approval process, or admitted a regulatory decision was influenced by politics, or accused a former commissioner of questionable conduct, according to The New York Times. Well, it managed to do all three this week when FDA officials came clean about their mistake in approving Menaflex, a patch for injured knees made by ReGen Biologics Inc.

FDA’s scientists told their superiors over several years that Menaflex was unsafe because it not only failed to help patients, but actually caused them to need more knee operations. But after four Democratic politicians from New Jersey—Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steven Rothman—along with former FDA commissioner Dr. Andrew C. von Eschenbach, lobbied the agency on behalf of ReGen Biologics, Menaflex was approved for the market. All four lawmakers talked to the FDA after receiving significant campaign contributions from ReGen.

The FDA is now considering withdrawing its approval of Menaflex.
                                                                                                                                                       -Noel Brinkerhoff

F.D.A. Reveals It Fell to a Push by Lawmakers (by Gardiner Harris and David M. Halbfinger, New York Times)