Statement from the Consumer Healthcare Products Association on Proposed New "Third Class" of Medicines

Washington, D.C. (November 14, 2007)—Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), regarding today’s FDA public meeting seeking comments on a proposed "third class" of drugs:

"On behalf of our member companies, CHPA was pleased to have the opportunity to offer perspective on today’s discussion of expanded consumer access to medicines. As the leading makers of OTCs, we know that improved access to these medicines provides an important, cost-effective, and convenient public health benefit for millions of consumers.

"As reflected in our presentation today, CHPA has always advocated for expanded access to nonprescription medicines, and we have made every effort to empower consumers with the additional tools and information needed to make appropriate decisions on OTC use.

"The last several years have seen a significant number of successful Rx-to-OTC switches across a wide range of therapeutic categories, which have benefited millions of patients with such conditions as migraines, frequent recurring heartburn, vaginal yeast infections, and hair loss. In itself, this is ample evidence that our current regulatory system allows for safe, expanded consumer access to medicines.

"Most importantly, flexibility is built in to the existing framework, with sponsors having the opportunity to work with the agency and to design the appropriate tools to address any challenges to that particular medicine. These tools add value and provide safeguards in the selection or use of these OTC switch medicines. Examples of this include informational and support strategies to support the Rx-to-OTC switches of nicotine replacement therapy (NRT), orlistat, and levonorgestrel.

"Like all things, the switch from prescription drug to over-the-counter status has its share of challenges, but based on these examples, we have concrete examples of success.

"Access to OTC medicines provides an important, cost-effective, and convenient benefit to consumers and to public health. Consumer access to NRT has resulted in tens of thousands of people quitting smoking every year, translating into an annual $2 billion social benefit. Additionally, due to the switch of a number of vaginal antifungals for recurrence of infections, women’s visits to the doctor for this condition were reduced by 15 percent in the first four years post-switch.

"We believe that existing statutory and regulatory laws offer sufficient flexibility for companies and FDA to explore new or different approaches to moving prescription medicines to nonprescription status. We are committed to providing innovative solutions to enhance consumer access to OTC medicines."

Contacts: Elizabeth Funderburk and Virginia Cox, 202.429.9260

CHPA is the 126-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.