1. Pink Sheet

FDA’s Top Two Reform Priorities Aren’t Really Legislative Material

 
• By Sarah Karlin-Smith

Senate eyes a biomedical reform process that is simultaneously narrower and slower than the House’s 21st Century Cures Initiative; FDA’s Hamburg asks for ability to shape sponsor’s trial designs earlier and more regulatory science funding.

Biomedical reform legislation is third on the Senate HELP Committee’s priorities for this Congress, but given the “fast-moving train,” the chamber’s leadership appears more interested in zeroing in on a few key transformations rather than producing the kind of “kitchen sink” reform the House Energy and Commerce Committee seems to be pursuing.

Unfortunately for FDA Commissioner Margaret Hamburg and NIH Director Francis Collins, the priorities they listed for the Health, Education, Labor and Pensions Committee may not be the most politically viable...

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• By Sarah Karlin-Smith

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