Positioned to take over leadership of the Food and Drug Administration during a period of immense overhaul, former New York City Health Commissioner Margaret Hamburg is eliciting early support from the drug and medical-device industries and watchdog groups.
Time of transition
Hamburg must ‘restore’ trust: exec
Hamburg, approved last week by the full Senate but not yet sworn in at deadline, faces a laundry list of pressing tasks for turning around the beleaguered agency. They include directing the use of the agencys increased appropriations, overseeing the creation of an improved imports inspection program, and ensuring the effectiveness and transparency of new drug and medical-device approval programs.
I think she is going to do a lot to restore Congress and the publics trust in the FDA, said Steve Ubl, president and CEO of the Advanced Medical Technology Association, a lobby group for the medical-device industry. If you look at her confirmation process, she was widely regarded on both sides of the aisle, he said. The drug industry lobby group Pharmaceutical Research and Manufacturers of America also voiced support, saying in a written statement that Hamburg will provide strong leadership.
Hamburgs supporters acknowledged, however, that the new commissioner faces a unique learning curve given the changes the FDA must undertake to restore its image following harsh criticism about its effectiveness. The rebukes include a January report from HHS inspector generals office pressing the FDA to ramp up efforts to obtain full conflicts-of-interest disclosure from researchers involved in clinical trials, and a Government Accountability Office report that same month that found the agency used a less-stringent process than mandated to approve the sales of 24 high-risk medical devices.
Along with fixing such problems, the medical products industry is also looking for Hamburg to act quickly on the new-products innovation front, Ubl said.
High expectations could certainly test the new commissioners mettle, said Steve Grossman, deputy executive director of the watchdog group Alliance for a Stronger FDA. She understands theres a lot of work to be done, and the more she gets into it, the more shell understand how much of it is cost driven, Grossman said.
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