FDA To Consider Reforms
FDA over the next year plans to consider reforms to the operations of agency advisory committees that make recommendations on prescription drug approvals and safety, the Wall Street Journal reports. The reforms initially will involve the 16 committees under the FDA Center for Drug Evaluation and Research.
The committees each have about 12 members, which include physicians who treat patients, researchers and experts from other federal agencies. In addition, the committees include a pharmaceutical industry representative and a patient representative, neither of whom votes on recommendations.
FDA in most cases accepts committee recommendations on whether and under what conditions to approve prescription drugs. Although the committees must follow financial disclosure guidelines and "broadly act in a similar manner," they differ in certain practices, such as the conduct of discussions and votes, the Journal reports.
FDA Deputy Commissioner Scott Gottlieb in an interview said that the agency will seek to improve the consistency and predictability of the operations of the committees.
Debbie Henderson, director of the office of executive programs at CDER, said that FDA staff members and some pharmaceutical companies have said certain committees operate more effectively than others, adding the agency will seek to apply the best practices from each committee to all committees.
FDA also will consider the appropriate level of involvement for agency division heads in committee meetings because some division heads take more active roles than others (Corbett Dooren, Wall Street Journal, 5/10).