Rost's FDA push makes PharmaTimes

A leading US politician has told President-elect Barack Obama that “a complete change” is needed in the leadership of the Food and Drug Administration (FDA), as the agency’s current senior staff are “too close with the industries they regulate, creating a question of whom they are working for.”

“I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA,” writes Bart Stupak, the Democratic Representative for Michigan, in a letter to Mr Obama released last Friday. While he names no agency officials in his letter, Rep Stupak’s plea to the incoming president is being widely seen as an attempt to counter support for Dr Janet Woodcock, head of the agency’s Center for Drug Evaluation and Research (CDER), to be the next Commissioner, or to take the post on an interim basis, when Dr Andrew von Eschenbach steps down.

Commissioner von Eschenbach, who has held the post since September 2005, has made no announcement about his future plans, but his resignation is expected shortly.

Rep Stupak has been a member of the House Energy and Commerce Committee for 12 years, during which time he has been involved in “numerous” investigations of the FDA, he tells Mr Obama. Also, for the past two years has chaired the panel’s oversight and investigations subcommittee, which has primary oversight of the FDA, and: “since February 2007, I have held 16 hearings into the inadequacies of the FDA to protect Americans from unsafe food, drugs and medical devices. The subcommittee’s investigations revealed how the current FDA senior management blocked clinical trials, drove dedicated medical professionals out of the agency and lined their pockets with outrageous bonuses. The agency has abandoned its core mission of protecting Americans from contaminated food, unsafe drugs and medical devices,” he writes.“A new Commissioner or Interim Commissioner must bring the agency back to the forefront of science, integrity and transparency,” Rep Stupak urges the incoming president.

CDER director Dr Woodcock is widely reported to be the industry’s choice to lead the Administration. This fact alone could be enough to wreck her chances of landing the post, and her 22 years at the agency also means that she is not regarded as a likely force for reform.

Pfizer whistleblower says: “I want to be FDA Commissioner

Meantime, a new name in the frame for FDA Commissioner is Peter Rost, the controversial former Pfizer vice president who is currently involved in long-running whistleblower litigation against his former employer. He has made public his interest in the agency top job and is being supported by Democrat Sherrod Brown, the junior Senator from Ohio, with whom he has campaigned for imports of cheaper prescription drugs from Canada, and by Missouri Democrat Representative Jo Ann Emerson. Rep Stupak is also reported to be backing Mr Rost.

By Lynne Taylor
PharmaTimes