FDA Schedules Public Meeting to Discuss OTC User-Fee Program

The FDA is considering creating a user-fee program for OTC drugs to hire additional staff to expedite the monograph OTC drug review process.

The agency said that it has only 18 employees to manage monographs, and new resources would expedite reviews, as well as the modification of labels for new safety concerns.

The FDA is seeking feedback on the proposal, asking stakeholders to weigh in on several factors, including the appropriate user fees ranging from product listing fees to application fees. When considering the type of fee the agency asks industry to bear in mind:

• The nature of monographs, which don’t require a premarket application, regarding the application-fee route;
• Industry activities that may be discouraged given the assessment of fees; and
• The “stability and predictability” of the resources provided by the type of fee.