FDA nomination reflects split in agency's role

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Nearly a week after the story leaked, President Obama made his picks to head the FDA official in his weekly address Saturday.

Obama will nominate Dr. Margaret Hamburg, a biodefense expert and former New York City health commissioner, to serve as FDA commissioner, and appoint Baltimore health commissioner Dr. Joshua Sharfstein as principal deputy commissioner.

“As Baltimore's health commissioner, Dr. Sharfstein has been recognized as a national leader for his efforts to protect children from unsafe over-the-counter cough and cold medications,” Obama said, “and he's designed an award-winning program to ensure that Americans with disabilities had access to prescription drugs.”

The appointments, some noted, may portend a more formal split of the agency's responsibilities for food and drug safety. Rep. Rosa DeLauro (D-CT), who chairs the FDA and agriculture subcommittee of the Appropriations Committee, has introduced legislation that would create a separate Food Safety Administration. In that scenario, Hamburg would likely lead the new food safety agency, while Sharfstein would be in charge of drug safety.

“[Hamburg] has a deep science background, which perfectly positions her to take on the food and tobacco elements of the FDA – which will be spun out of the agency,” said former FDA associate commissioner for external relations Peter Pitts, who now heads Porter Novelli's global healthcare practice and the Center for Medicine in the Public Interest. “Sharfstein is more politically savvy, and has a background in drugs and devices. He's a great candidate for that side of the operations.”

Where Hamburg seems an uncontroversial candidate, Sharfstein is viewedby some as hostile toward the drug industry. Unlike Hamburg, he willnot have to go through a Senate confirmation.

Obama's weekly address focused chiefly on food safety and the “troubling trend” of contaminated produce in recent years, which he said troubled him not only as president but as a parent. He pointed to laws not updated since Teddy Roosevelt's day and a system of enforcement underfunded, understaffed and spread too thin.
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