FDA reviewers didn’t get to vote on first priority voucher drug

WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one- to two-month drug review, culminating in a one day “tumor board” style meeting where leaders decide whether to approve the drug. 

STAT has learned that when the agency voted on whether to approve the first product from a voucher recipient in October, the voting members did not include the review team. Instead, the voting panelists were leaders from the top of the agency, according to three agency sources. It is not clear what the outcome was. The agency has not yet publicly announced the approval decisions for any of the voucher recipients.

That’s a major departure from the agency’s typical practice of investing this power in career officials, to avoid the perception of politics influencing the approval process. It’s the latest example of how political influence is shaping FDA’s scientific decision-making. 

The voting officials were: