An FDA Committee for FDA Advisory Committees
This article was originally published in RPM Report
Drug sponsors craving consistency among the Food & Drug Administration's advisory committees take heart: changes are underway to make the process more predictable. FDA's Center for Drug Evaluation & Research is undertaking a one-year review of the advisory committee process to identify "best practices" that can be adopted across all the drug review divisions.
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Reconstructing Advisory Committees: FDA Conflict of Interest Policy Will Pose Challenges for Drug Sponsors
Drug sponsors soon will have another hurdle to overcome at advisory committee meetings: significant turnover in the experts asked to consider the approvability of their products. The new policy will help FDA quiet critics of the agency's advisory committee system, but it will also create more noise around the drug approval process.
FDA's advisory committee process has long been criticized for conflict of interest issues. But now those on the inside are questioning whether change is needed. At the same time, some FDA officials don't believe advisory committees add much to the review process. And given resource constraints, FDA is holding committees less and less often. That may be good news for drug sponsors. The public disclosure of an NDA as part of the committee process leaves sponsors vulnerable to attacks that can undermine the future of a drug. Given the sway advisory committees in the court of public opinion, a re-examination of the system is coming.
Surge of interest prompts US FDA to consider how to adjust feedback, including potentially creating a separate team to answer more basic questions.