FDA's New Fast Drug Review Plan Comes with Tradeoffs for Pharma

Healthcare & Life Sciences Team Co-Leader Michael Werner was interviewed by Bloomberg Law about the U.S. Food and Drug Administration's (FDA) new Commissioner's National Priority Review Voucher program, which seeks to compress certain drug reviews from up to 12 months to as little as one month. Though the initiative could accelerate market access, particularly for complex areas like rare diseases, significant workforce reductions at the U.S. Department of Health and Human Services (HHS) affecting key FDA centers have raised concerns about the agency's capacity and potential ripple effects on non-voucher applications.

"What stakeholders are wondering is whether they have the resources," Mr. Werner said. "Programs for expedited review are really resource intensive – it's a time crunch."

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