OTC Cholesterol Drugs May Be Revisited By FDA In 2000
This article was originally published in The Tan Sheet
Executive Summary
FDA will re-examine the question of potential Rx-to-OTC switches of hypercholesterolemia drugs in 2000, including reexamination of a 1997 guidance finding such drugs inappropriate for over-the-counter sale, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said Dec. 16.
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FDA will re-examine the question of potential Rx-to-OTC switches of hypercholesterolemia drugs in 2000, including reexamination of a 1997 guidance finding such drugs inappropriate for over-the-counter sale, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said Dec. 16. Responding to questions about cholesterol-lowering claims raised during the Food Drug & Law Institute's annual educational conference in Washington, D.C., Woodcock said the issues will be evaluated "as part of our overall consideration of the role of OTC products." The "key for this is on what side does the net public health benefit fall for any given product," she added. The CDER director noted foods such as oat bran carrying cholesterol-lowering claims do not pose a harm to consumers who may use them improperly. To the contrary, "there's some harm that's going to be caused by almost every drug that exists. Are those types of harms balanced by the benefit that's provided by public access to medication?" Agency officials "really have to consult with the public" on the question of where "the net public health benefit arises or where does it fall on many novel proposals we've been receiving for over-the-counter switches," Woodcock maintained. In an October 1997 guidance, CDER said it concurred with the recommendations of the Nonprescription Drugs and Endocrinologic & Metabolic Drugs advisory committees that hypercholesterolemia treatment requires both preliminary and ongoing medical management and, consequently, is not suitable as an OTC indication. The advisory committees' findings and the 1997 guidance stemmed from Bristol-Myers Squibb's failed attempt to switch Questran (cholestyramine) OTC. FDA issued the guidance, in part, to advise companies against expending resources to switch cholesterol-lowering drugs (1 (Also see "Cholesterol drugs should not be available OTC, FDA guidance says." - Pink Sheet, 6 Oct, 1997.)). The Consumer Healthcare Products Association has repeatedly taken issue with FDA's position in rejecting OTC status for cholesterol-lowering treatments while allowing cholesterol-related claims on foods and supplements. |