FDA Has Regulatory Science Plan; Now It Needs Funding
This article was originally published in The Pink Sheet Daily
FDA Commissioner Hamburg is "guardedly optimistic" that Congress will give the agency funding beyond the continuing resolution that kept budgets at fiscal 2010 levels.
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Sean Tunis embraces a bigger decision-making role for CMS in product access, while FDA Commissioner nominee Robert Califf also calls for smoother FDA-CMS hand-offs, and CBER Director Peter Marks wants a quicker FDA-CDC approval and deployment process.
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.
Margaret Hamburg’s background in public health, as opposed to academic medicine, was off-putting to some in pharma initially, but she leaves the agency in March with high drug approval numbers, initiatives to improve the OTC monograph and switch programs and increased enforcement in the supplement manufacturing arena.