The US Food and Drug Administration (FDA) will hold a public meeting on June 10, 2016 in Silver Spring, Maryland, to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user fee program would provide funding to supplement Congressional non user-fee appropriations and would support timely FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.
The FDA provided notice of the meeting and requests for comments on a potential OTC monograph user fee program in a Federal Register posting dated May 10, 2016.
User fees are now in place for innovator drugs under the Prescription Drug User Fee Act (PDUFA) and for generic drugs under the Generic Drug User Fee Amendments of (GDUFA), but user fees for OTC drugs do not yet exist. The OTC drug approval process is distinct from the process for reviewing and approving new drug applications for new drugs and abbreviated new drug applications for generic drugs.
Under the OTC drug review process, expert advisory review panels evaluate evidence of safety and efficacy for ingredients in broad therapeutic classes of OTC drug products. These panels review data submissions and provided reports to the FDA. Those reports makerecommendations regarding whether or not the ingredients were “generally recognized as safe and effective (GRASE)” for use in self-treatment. The review panels also review claims and recommend appropriate labeling. Based on the panels' reviews, FDA publishes in the Federal Register advanced notices of proposed rulemaking and, after additional agency review and public comment, tentative final monographs. Subsequently, final regulations in the form of individual drug monographs are established for various therapeutic areas; these monographs establish conditions of use under which ingredients are considered GRASE for inclusion in an OTC drug.
There are approximately 88 simultaneous rulemakings in 26 broad therapeutic areas encompassing hundreds of thousands of products. There are approximately 800 active ingredients for over 1,400 different therapeutic uses. The FDA said that it needs additional resources to work toward finalization of the monograph review process and to address safety issues in a more efficient and timely manner. It said that additional resources would also better enable the agency to consider innovations for drug products containing monograph ingredients, such as the development of new dosage forms for ingredients under existing monographs.
Source: Federal Register