FDA Advisory Committees Would Get Patient Influence Under Hagan Bill
Adjusting advisory committee conflict of interest rules has emerged as a high-priority issue in reauthorizing the drug user fee program, and several bills already propose loosen those rules. Sen. Kay Hagan’s draft FDA reform legislation may prove to be the most loosening proposed to date.
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FDA offered Public Citizen’s Sidney Wolfe a seat at the table for discussion, but no vote. Members need to report relevant information about their conflicts in a timely manner, the agency says.
FDA’s Oct. 24 public meeting on the renewal of its drug user fee program demonstrated just how strong a position the agency is in regarding the renewal of the Rx part of the “UFA” legislation – most of the complaints were semantic, quite literally.
Recent improvements to FDA's screening process for intellectual conflicts of interest among advisory committee members are likely to be part of the agency's response to a congressional inquiry into the review of Lilly's prasugrel (Effient)