Switching to OTC enables manufacturers to extend their exclusive right to sell a drug for up to three additional years. The first statin on the market, Mevacor, is scheduled to go off patent next year. Once that happens, generic versions of lovastatin could cut deeply into sales of the brand-name product. Pravachol's patent doesn't expire until 2005. Millions of Americans have taken lovastatin, pravastatin or one of four other available statins to lower their cholesterol and reduce their risk of heart disease, the leading killer in industrialized nations.
Statins work by interfering with the body's ability to make cholesterol.
To me, it's actually a major public health problem that these drugs are not being used. Despite the FDA's official policy on cholesterol-lowering drugs going over the counter, there are signs that the agency may be reconsidering its stance. Another sign that the FDA may be reconsidering its policy is a two-day meeting on OTC switches beginning Wednesday, says Steven Francesco, president of Francesco International in South Orange, N.J., publisher of Switch , an industry newsletter. The switch meeting in June gives them permission to revisit policy. It's sort of going from first generation to third generation.