StrangeSox Posted September 25, 2009 Share Posted September 25, 2009 F.D.A. Reveals It Fell to a Push by Lawmakers The Food and Drug Administration said Thursday 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 F.D.A. 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, said he had acted properly. The agency 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. “The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters. Link to comment Share on other sites More sharing options...
Rex Kickass Posted September 25, 2009 Share Posted September 25, 2009 If this is true, its a huge disappointment to me about Pallone. The others don't surprise me, but I thought Frank would be better than that. Link to comment Share on other sites More sharing options...
bmags Posted September 25, 2009 Share Posted September 25, 2009 Really wouldn't mind this taking down menendez. Link to comment Share on other sites More sharing options...
Rex Kickass Posted September 25, 2009 Share Posted September 25, 2009 QUOTE (bmags @ Sep 25, 2009 -> 04:22 PM) Really wouldn't mind this taking down menendez. Would prefer him to be taken down with a Dem governor at the helm though. Link to comment Share on other sites More sharing options...
bmags Posted September 25, 2009 Share Posted September 25, 2009 QUOTE (Rex Kicka** @ Sep 25, 2009 -> 08:50 PM) Would prefer him to be taken down with a Dem governor at the helm though. baha, jeeze Corzine just ran a spanish ad with Menendez. Link to comment Share on other sites More sharing options...
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