J&J/Merck Seek OTC Status for Mevacor

As part of their new joint venture, Johnson & Johnson and Merck want to take their cholesterol-lowering drug Mevacor (lovastatin) from prescription to over-the-counter status, according to company officials.

FDA regulators would have to approve the move, which marks the second time in two years the company sought such clearance. In 2000, the plan was temporarily scuttled by FDA, which said it wanted more studies, primarily on the public's ability to self diagnose.

Brian Perkins, chairman of J&J's consumer pharmaceuticals and nutritionals division, says, although there are no guarantees of a positive outcome, he is optimistic FDA will approve the measure. "More and more, some of the costs of prescription drugs are being passed to consumers via co-payments," Perkins recently told a group of investment analysts. "As these co-pays rise, OTCs become a more attractive option for consumers in many categories, where OTCs and prescription products are both options."

The J&J/Merck alliance already has some experience marketing OTC remedies with products such as the Pepcid series of heartburn medicines.

According to Perkins' estimates, the prescription market for anti-cholesterol medications is about $12 billion per year, so Mevacor's potential switch to OTC status could have far-reaching affects on the category. Other major players include Bristol-Myers Squibb's Pravachol (pravastatin), Merck's Zocor (simvastatin), and Pfizer's Lipitor (atorvastatin).

Perkins estimates the current market is growing at about 25 percent annually. "I am certainly not suggesting the OTC statin market will approach these kinds of numbers [25 percent growth], but it does suggest over-the-counter potential."

What Perkins is referring to is the potential savings consumers might realize. With health insurance co-pays for prescription drugs rising, patients might gravitate to OTCs, which often cost less. Even when co-payments cost less than OTCs, the non-prescription versions are often still more attractive to some consumers because it allows them to avoid visits to the doctor.