Pharmaceutical, Medical Device Industries Concerned About Sharfstein As FDA Deputy Director

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry;  Medical Devices / Diagnostics
Article Date: 20 Mar 2009 - 6:00 PDT

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The pharmaceutical and medical device industries have praised the nomination of former New York City Health Commissioner Margaret Hamburg as FDA commissioner, but they are "nervous in varying degrees" about the nomination of Baltimore Health Commissioner Joshua Sharfstein as principal deputy commissioner of the agency, CongressDaily reports.

According to one lobbyist, Sharfstein likely "will have a certain amount of autonomy on pharmaceuticals and medical devices," as Hamburg likely will focus on food safety and tobacco regulation. The lobbyist added, "Companies are clearly going to get more scrutiny" under Sharfstein.

As a former staffer for House Energy and Commerce Committee Chair Henry Waxman (D-Calif.), who "has been tough on drug companies," Sharfstein "has a long and sometimes contentious history with the pharmaceutical industry," CongressDaily reports. "Sharfstein has carried the torch on many of his boss's public health priorities" -- such as efforts to limit off-label use of medications and gifts from pharmaceutical companies to physicians -- and he "could play a key role implementing 2007 FDA legislation" that requires pharmaceutical companies to develop risk evaluation and mitigation strategies, according to CongressDaily.

Peter Pitts, a former FDA associate commissioner for external affairs and co-founder of the Center for Medicine in the Public Interest, said that many of the concerns about Sharfstein raised by the pharmaceutical and medical device industries are unfounded. "I don't think you'll see more strident regulations," he said, adding, "I think you'll see a more effective way to use existing regulation" (Edney, CongressDaily, 3/18).

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