STAT FDA Review Staff Excluded from Voting on Priority Voucher Drug Approval
The Food and Drug Administration (FDA) has committed to providing companies that earn a Commissioner’s National Priority Voucher with an expedited drug review process. This process typically lasts one to two months and concludes with a one-day “tumor board” style meeting. During this meeting, agency leaders decide whether to approve the drug. However, STAT has learned that in October, when the FDA voted on the approval of the first product from a voucher recipient, the review team was excluded from the voting panel.
According to three sources within the agency, the voting members did not include the FDA review staff who had worked on the drug. Instead, the panel consisted solely of leaders from the top levels of the agency. The outcome of the vote remains unclear, as the FDA has not publicly announced any approval decisions for products from voucher recipients to date.
Departure from Standard FDA Practices in Drug Approval Process
This approach marks a significant departure from the FDA’s usual practice. Typically, the agency entrusts approval decisions to career officials who have been involved in the review process. This standard method helps to maintain the integrity of the process and reduces concerns about political influence affecting scientific decisions.
Excluding the stat FDA review staff from the voting panel raises questions about the role of politics in the agency’s scientific decision-making. It highlights ongoing concerns about political influence shaping the FDA’s approval process, especially for drugs reviewed under the priority voucher program.
Implications of Excluding Stat FDA Review Staff from Voting
The decision to remove the review team from the voting panel for the first priority voucher drug approval is unusual and has not been explained publicly. It is unclear why the FDA chose to have only senior leaders vote on the approval rather than including the experts who conducted the detailed review.
This move could signal a shift in how the FDA handles high-profile drug approvals, potentially prioritizing leadership decisions over the input of career scientists and reviewers. The agency’s failure to announce the results of the vote adds to the uncertainty surrounding the approval process for drugs under the Commissioner’s National Priority Voucher program.
In summary, the exclusion of the stat FDA review staff from the voting panel during the first priority voucher drug approval vote represents a notable change in FDA procedures. It underscores concerns about political influence in scientific decisions and raises questions about the transparency and integrity of the agency’s drug approval process.
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Source: original article.