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12:00 AM
Dec 14, 2009
 |  BioCentury  |  Regulation

The Hamburg surprise

It would have been easy for FDA Commissioner Margaret Hamburg to ignore Sens. Sam Brownback (R-Kan.) and Tom Carper (D-Del.) when they sent letters asking for the agency's views on a politically popular bill that seeks to allow drug importation. She also could have delayed responding until after the Senate had moved on to other topics. Instead, she wrote letters damning the bill with faint praise and identifying flaws she warned could expose Americans to unacceptable safety risks.

Democrats may have been surprised that a political appointee of the Obama administration has rebuffed her own boss by echoing FDA commissioners from the Bush administration. But it should give populists from both parties in Congress food for thought that FDA commissioners from very different political perspectives have come out against importation based on safety.

Because she didn't duck, Hamburg became a target for bipartisan attack as the Senate began debate on an importation amendment filed by Sen. Byron Dorgan (D-N.D.). Senators on both sides focused their comments on Hamburg's letters to Brownback and Carper. In typical Washington fashion, those who oppose her position impugned Hamburg's motives and integrity, not the substance of her comments.

Dorgan's bill, which has 32 Senate sponsors and could easily attract the 60 votes required for passage, would allow pharmacies to import drugs from Canada, the EU, Japan and other...

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