(WASHINGTON, D.C.) — Consumer Healthcare Products Association (CHPA) Vice President, Regulatory & Scientific Affairs Barbara A. Kochanowski, Ph.D. spoke today on behalf of CHPA during the U.S. Food and Drug Administration (FDA) Public Meeting on OTC Monograph User Fees. CHPA is the trade association that represents the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements.
In her statement, Kochanowski highlighted both the benefits of OTCs and the Monograph system to public health as well as areas of needed reform. 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.
"Unlike other drugs subject to user fees, nonprescription drugs under the Monograph system are not subject to FDA approval prior to marketing. 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. 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.
“Fees for nonprescription medicines under the Monograph system could be a disincentive for innovation, or they could incentivize innovation, depending on how they are applied. For example, today, very few manufacturers are filing New Drug Applications and paying the PDUFA fee to innovate with Monograph ingredients. Discussion of a potential user fee program should include identifying mechanisms to support innovation.”
