CHPA testifies on impact FDA's proposed OTC Monograph User Fees may have on innovation

WASHINGTON — Testifying before the Food and Drug Administration, the Consumer Healthcare Products Association on Friday expressed cautious optimism on the impact OTC Monograph User Fees may have on OTC innovation. 

 

“Unlike other drugs subject to user fees, nonprescription drugs under the Monograph system are not subject to FDA approval prior to marketing," noted Barbara Kochanowski, VP regulatory and scientific affairs. "Many of these ingredients have been marketed for more than 40 years, with a long history of safe use. There is no backlog of applications. Therefore, we must define value differently than industries subject to FDA approval prior to marketing," she said. " As FDA correctly identifies in the meeting notice, assessment of fees can create certain incentives or disincentives for activities that are subject to fees.  Neither we, nor FDA, nor the public want to discourage activities that could benefit public health."

 

Depending upon how these fees are structured, OTC PDUFA fees could be as much a disincentive as it is an incentive to innovation. "For example, today, very few manufacturers are filing New Drug Applications and paying the PDUFA fee to innovate with Monograph ingredients," Koxhanowski said. "Discussion of a potential user fee program should include identifying mechanisms to support innovation.” 

 

In regard to a user fee program, Kochanowski asserted the industry’s position that a user fee program for nonprescription medicines will require thorough discussion and study.