CHPA, FDA discussing user fee program for OTC drugs

WASHINGTON —  Since the Food and Drug Administration’s March 25, 2014 Part 15 public hearing on the OTC Drug Monograph, the Consumer Healthcare Products Association has been in discussions with FDA and relevant committees in Congress to identify potential enhancements that would update and modernize this regulatory framework for most nonprescription medicines.

"CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive and accommodating to innovation," the association noted in a press release issued Tuesday. "We recognize that resource constraints would affect the ability of FDA to implement any potential monograph reforms, and we are open to discussing ways of adequately funding reforms, including consideration of a user fee program for OTC drugs."

Following the FDA Public Meeting on OTC Monograph User Fees on June 10, 2016, CHPA has entered the stage of discussion that will include detailed talks about the parameters of a potential user fee framework.

Any such framework would require Congressional action. The FDA will post public minutes of these meetings on its website.