The FDA’s First Public Meeting on Potential Over-the-Counter (OTC) Monograph User Fees

The FDA is announcing a public meeting 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 and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.

In large part, the OTC monograph drug review process has been successful – the FDA was able to make determinations about the general recognition of safety and efficacy of the active ingredients in thousands of OTC products through this process. However, rapidly evolving science, emerging safety issues, and drug development innovations require a more agile and responsive process than the process the FDA set up in the early 1970s in order to serve the public health effectively. The FDA also needs additional resources to modernize the OTC review process to keep up with evolving science and the fast pace of the pharmaceutical and consumer healthcare products industry, and to finalize the pending monographs. There has been substantial growth in the number of OTC products on the market and it is part of the FDA’s mission to ensure that these OTC drugs are safe and effective for consumers to use.

Prescription Drug User Fee Amendments (PDUFA) and Generic Drug User Fee Amendments (GDUFA) have allowed both the new drug and generic drug application review processes to modernize by providing resources and allowing for more timely and efficient review of applications. User fees for OTC monographs could potentially have a similar positive effect for OTC monograph products

For additional information, please visit:

• Public Meeting on Over-the-Counter Monograph User Fees
• Frequently Asked Questions: June 10, 2016 Public Meeting on OTC Monograph User Fees 
• Federal Register Notice