FDA Considers New User Fee Program for OTCs

FDA, which relies heavily on user-fee programs to review prescription drugs in an expeditious fashion, may adopt a similar framework to tap industry financial support for the OTC drug evaluation process. Currently, hundreds of thousands of OTC medications—including analgesics, cough and cold treatments, and antiseptics—are marketed through “monographs” without being sanctioned by FDA. Lack of funding and staffing, meanwhile, have slowed finalization of these monographs, giving consumers access to OTC drugs that have yet to be cleared as safe and effective by the agency. “FDA needs additional resources to work toward finalization of the monograph review process and to address safety issues in a more efficient and timely manner,” according to the regulator, which has scheduled a public meeting for June 10, 2016, to hear feedback. In particular, it hopes to obtain stakeholder insight on the kinds of user fees that might work best, the types of performance objectives that might be important, and the best way to evaluate the success of a such a program. See: Federal Register Notice.