STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug
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WASHINGTON \u2014\u00a0The Food and Drug Administration has promised companies that earn a Commissioner\u2019s National Priority Voucher<\/a> a one- to two-month drug review, culminating in a one day \u201ctumor board\u201d style meeting where leaders decide whether to approve the drug.\u00a0<\/p>\n 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.<\/p>\n That\u2019s a major departure from the agency\u2019s typical practice of investing this power in career officials, to avoid the perception of politics influencing the approval process. It\u2019s the latest example of how political influence<\/a> is shaping FDA\u2019s scientific decision-making.\u00a0<\/p>\n The voting officials were:\u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n