Will Hamburg run FDA for another 4 years?

Speculation is that if President Obama is re-elected, Margaret Hamburg will continue as FDA commissioner. Elsevier Business Intelligence says Health and Human Services Secretary Kathleen Sebelius, who is Hamburg's boss, is not expected to want to bring in new faces as the Affordable Care Act kicks into high gear in 2014. A variety of new initiatives of concern to drugmakers could be affected if Hamburg were to leave. One of the key ones for the manufacturing divisions is the ramping up of inspections throughout the world funded out of additional fees being collected under the FDA reauthorization. It is not clear what would be in store for the agency if former Massachusetts Gov. Mitt Romney is elected. Hamburg and the FDA did come under fire this year by a House committee that accused her of being too aggressive on plant inspections. The result, a House report said, was that plants closed down to address FDA concerns, leading to drug shortages. The agency responded by pointing out that patients were put at risk by some of the poor-quality manufacturing inspectors uncovered. Report | More

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