FDA: Review of Advisory Committees 2008-2012, Fewer Meetings and More Approvals

Over the years, we have written about the FDA's Advisory Committees with a special interest on "conflict of interest" issues. Recently, Avalere researchers published an interesting look at FDA's Advisory Committees (AdComm), considering trends in the first three years of current user fees. The study aimed to provide insight into developments regarding FDA's approach to the AdComm process. The research is based on data from programs related to the FDA Safety and Innovation Act. The follow information can be found in the Avalere report. Advisory Committees The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires FDA to hold Advisory Committee meetings for the approval of all new molecular entities. The researchers point out that the process surrounding AdComms "remains a source of significant uncertainty for biopharmaceutical and medical device product sponsors." Mandatory meetings are required in the review of pediatric adverse events or labeling changes, biannual Drug Safety and Risk Management committee meetings on postmarket safety, and device classification/reclassification. AdComms are comprised of members that are appointed by the FDA Commissioner based on their scientific or technical expertise, and supplemented by other experts as needed. FDA has 34 standing AdComms and although the agency is not required to follow the advice of the AdComms, it generally does when evaluating product approvals. The researchers point out that "of the 214 AdComms conven...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs