FDA and industry should immediately begin pursuing the development of a regulatory process for a behind-the-counter class of drugs, FDA Commissioner Andrew C. von Eschenbach, M.D., told OTC industry executives March 16.

To increase consumer access to health care products, stakeholders should explore "new ways that might include the opportunity to think through and pursue the process of a third class of drugs that are regulated by FDA," the commissioner said at the Consumer Healthcare Product Association's annual executive conference in Naples, Fla.

When asked about his projected time table for the creation of the third class, von Eschenbach quipped, "I'm a surgical personality so that means the time-line was yesterday." The process is "something that's timely, so it should begin now."

Von Eschenbach described products that would be included in the potential pharmacy drug class as "medications that can be available without the need for a prescription by a health care professional, but are delivered in the context of being able to have patients guided and directed and instructed about their appropriate use."

The commissioner sees a third class as a route for increasing, rather than restricting access to consumers.

The goal of developing an intermediate class would be to "expand access to the patients, to the public, to consumers, if you wish, access to products, drugs, biologics, devices, etc. that we regulate and to do that in a way that still provides safeguards with regard to the appropriate use, but doesn't necessarily involve the need for them to undergo a medical evaluation and the need for a formal prescription on the part of the health care provider," he said.

Von Eschenbach said some products may not need a medical evaluation to take place, or a formal prescription, but may require more than the consumer's ability to read and comprehend a label to ensure appropriate selection.

"It may involve a dialogue for assurance of [comprehension], or providing unique or specific information with regard to that. And then that would provide, I think, much greater options and then much more opportunity for the patients we're here to serve."

CHPA President Linda Suydam stated the association is interested in building new distribution channels for its members' products, but has questions about a third class status.

"We're really anxious to undertake this discussion with the FDA," Suydam said.

John Hendrickson, CHPA chairman and Perrigo Consumer Healthcare executive vice president and general manager, clarified industry's apprehension about the establishment of a third drug class.

"I think the concerns in general of a third class have been to not create a U.K.-type system where things are switched to Pharmacy Only and stay there for life," Hendrickson said.

"Things get locked in that class, so they have a very underdeveloped true OTC business," he said.

"What CHPA has always espoused is that we believe in individual companies' abilities to develop appropriate means of educating consumers, of using pharmacists to help promote and drive their products," he continued.

A third class has been discussed by the industry and regulators for years, but resurfaced in recent years with Merck's attempt to switch the statin Mevacor and with the Plan B switch approval, which mandated behind-the-counter sale (¹ Also see "Mevacor OTC Panel Rejection Elicits Third Drug Class Talk" - Pink Sheet, 17 January, 2005., p. 3 and ² Also see "Plan B Restrictions Set “Unique Example” Experts Say, But What May Follow?" - Pink Sheet, 11 September, 2006., p. 3).

According to the commissioner, a third drug class would bring more nuanced flexibility to the spectrum of heath care services by adding an educational component for consumers through pharmacists' guidance on beneficial therapies and products previously available only with prescriptions.

The drug classification system runs on a "full continuum to provide and amplify the opportunity ... to expand that access" to more effective health care, he said.

Von Eschenbach said FDA needs to determine whether it currently has authority to create a third class. "It would be important to look at this from the perspective of what would be required in the way of regulations and what would be required in the way of legislation."

- Jessica Lake (j.lake@elsevier.com)

Von Eschenbach Promotes Behind-The-Counter Drug Class

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