FDA Panel Denies Merck's Application for OTC Mevacor

A joint panel of FDA advisers has recommended the agency not approve Merck's application to convert its cholesterol-lowering statin Mevacor from prescription to OTC status -- a move that will likely dampen efforts for OTC switches of other statins that are set to lose patent protection.

In a 20-3 vote, the Nonprescription Drugs and Endocrinologic Advisory and Metabolic Drugs Advisory Committees said the proposed OTC Mevacor (lovastatin), 20 mg should not be marketed at this time. The FDA is not required to follow an advisory committee's recommendation, but it usually does.

Many panelists noted that patients wouldn't be able to diagnose themselves for the OTC product, and would need additional monitoring. Panel members also expressed concern that pregnant women might take the OTC product, even though the target population is women 55 years and older and for men 45 years and older. Animal studies have shown the drug can cause profound birth defects, the panel noted.

While the panel agreed unanimously that the sponsors, Merck and Johnson & Johnson, had provided "adequate rationale" for the use of a 20-mg lovastatin to lower cholesterol levels and heart attack risks in the target population, the committee agreed that more research must be done before it could recommend approving Mevacor as an OTC drug.

Still, numerous panelists noted that they could support the product if it were available behind-the-counter, meaning consumers would require some assistance from a pharmacist to purchase the drug. Although this system operates in other countries, including the UK where Merck's statin Zocor (simvastatin) is available without a prescription, the U.S. does not have a system in place for behind-the-counter products.