Cholesterol Rx Drugs Reported Topic Of July NDAC Meeting
This article was originally published in The Tan Sheet
Executive Summary
FDA may be moving toward softening its firm stance, announced in a 1997 guidance, against over-the-counter use of cholesterol-lowering drugs.
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Prescription drugs that treat risk factors, rather than a chronic illness, may not be ideally suited for Rx-to-OTC switches due to the danger of side effects, FDA's Robert DeLap, MD/PhD, suggested at the Drug Information Association annual meeting in San Diego June 12-13.
Cholesterol drug reviews
FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees will discuss the OTC switch potential of Merck's Mevacor (lovastatin) on July 13 and Bristol-Myers Squibb's Pravachol (pravastatin) on July 14, the agency confirms (1"The Tan Sheet" April 17, p. 3). The proposed OTC indication of both drugs is to "treat individuals with total cholesterol levels of 200-240 mg/dL and low density lipoprotein levels over 130 mg/dL," FDA reports. However, for Mevacor, the indication would apply to "men over 40 and postmenopausal women who do not have established cardiovascular disease or diabetes." Pravachol's proposed indication - "for individuals who do not have established cardiovascular disease or diabetes" - is not age- or gender-specific. A July 12 NDAC session also is scheduled, although a topic has yet to be announced. As a precursor to the advisory committee meeting, FDA is holding a public forum June 28-29 on the suitability of marketing certain Rx drug classes OTC (2"The Tan Sheet" May 1, p. 3)
Rx-To-OTC Switch Flips On With June Public Forum, July NDAC Meeting
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.