The suitability of specific Rx drug classes - such as antihypertensive agents, osteoporosis treatments and oral contraceptives - for OTC use will be examined by FDA at a June 28-29 meeting in Gaithersburg, Md.

Cholesterol-lowering drugs, diuretics, oral antidiabetic agents and antimicrobials are among the other Rx drug categories that might be discussed, FDA says in an April 27 Federal Register notice requesting comments on a variety of switch-related issues.

The agency seeks input on whether there are specific classes of products, not currently marketed OTC, that should be available over-the-counter, what specific evidence should be required to support such approvals, and whether there are specific classes that should not be available OTC.

The agency says it is examining its overall philosophy and approach to regulating OTC drug products "in light of the continuously changing health care environment, including the growing self-care movement."

The public meeting represents renewed FDA focus on switch issues following a slow 1999 in which only two Rx drugs - Novartis' Lamisil AT antifungal and Habitrol nicotine patch - were approved for OTC sale.

FDA's Nonprescription Drugs Advisory Committee convened only once in 1999 - a July 20 joint meeting with the Arthritis Advisory Committee to consider switching Merck's Flexeril 5 mg for relief of muscle spasms in the back and neck. A formal vote was not taken (¹ Also see "Flexeril Indications Self-Diagnosis Seen As Significant Hurdle By Committee" - Pink Sheet, 26 July, 1999.).

However, the June forum on general switch-related issues is seen as a preview to a scheduled July 13-14 joint meeting of NDAC and the Endocrinologic & Metabolic Drugs Advisory Committee, which are expected to consider the potential switch of one or more Rx cholesterol-lowering statin drugs (² Also see "Cholesterol Rx Drugs Reported Topic Of July NDAC Meeting" - Pink Sheet, 17 April, 2000.).

FDA has assembled a list of issues "of specific interest" to the agency. Comments are requested on criteria FDA should consider in deciding on OTC availability and what types of diseases are or are not suitable for OTC treatment, such as chronic illnesses, diseases that initially require physician diagnosis, and diseases that, if left untreated or inadequately treated, can lead to serious morbidity or mortality.

"How should the risks and benefits to individuals and risks and benefits to the public health be assessed and weighed in any decision on OTC marketing," FDA asks, citing as an example antimicrobial agents and resistance.

The agency requests input on consumer understanding of the benefits and risks of specific drug products and the ability of consumers to use products safely and effectively if they are marketed OTC.

Potential topics for discussion include sampling criteria for comprehension studies, language barriers, appropriate use and interpretation of self-administered diagnostic tests, ramifications of misdiagnosis and consumers' ability to appreciate the need for continuous treatment and follow-up.

Other suggested areas for reflection include consumer confusion between trade names and generic/chemical names, and confusion created when the active ingredients generally associated with a brand are not present in some of the brand's extensions. Adequate conveyance through labeling of efficacy information is another area of concern cited by FDA.

"Can prevention claims encourage ill-advised behavior, and if so, how could this potential be minimized," the agency asks. "For example, would use of a cholesterol-lowering drug allow patients to ignore other needed interventions, such as smoking cessation, dietary discretion and management of other risk factors?"

The agency raises a number of questions regarding selection of treatment where prescription and OTC therapies co-exist, including whether the first drug to enter the OTC market in a therapeutic class should be the "best" drug under a risk/benefit ratio, and how the presence of a "better" OTC product, in terms of safety or efficacy, would affect the status of products already marketed OTC for the same condition.

FDA urges commenters to consider the adequacy of the OTC marketing structure in the U.S., including lessons learned from other countries where nonprescription drugs are sold "behind the counter." Finally, FDA asks under what circumstances it should actively propose OTC marketing for a drug absent a sponsor's support, and whether the agency should be more active in initiating switches.

Comments for consideration at the meeting are due by June 2. Written comments will be accepted until Aug. 25.

Rx-To-OTC Switch Flips On With June Public Forum, July NDAC Meeting

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