Cholesterol drugs "still poised for US OTC switch, despite Mevacor setback"

In its US application to switch its cholesterol-lowerer Mevacor (lovastatin) from prescription to over-the-counter status, Merck & Co maintains that the statin is safe to use without a physician's guidance. Last month, a US Food and Drug Administration advisory committee disagreed, recommending against the switch (Marketletter January 24).

The results of the panel vote, while disappointing for Merck and its joint venture partner, Johnson & Johnson, should be only a temporary setback for the cholesterol-lowering drug class, which is still among the most likely candidates to produce the first US Rx-to-OTC switch of a medication used to treat serious chronic but asymptomatic conditions, says a new market study being undertaken by Kline & Co. The billion-dollar question for marketers is: whose product will be on the drugstore shelves first, it adds.

"There's a very good chance that at least one of the many cholesterol drugs being marketed now will switch in the next few years," said Laura Mahecha, industry manager for Kline's health care practice. "Everyone will be looking at the FDA's final judgment on Mevacor very carefully to see what they'll need to do to get approved," she added.