FDA panels vote against OTC status for statin drug

Concern that patients would be taking the medication inappropriately led to a decision to continue to have physicians supervise patients who could benefit from Mevacor.

By Susan J. Landers, AMNews staff. Feb. 7, 2005.

Washington -- Helping people lower their artery-clogging cholesterol is an admirable goal, but selling a popular statin drug without a prescription is not the way to go, said two Food and Drug Administration advisory committees during a joint meeting in mid-January.

The panelists voted 20-3 against over-the-counter distribution of 20 mg tablets of Mevacor (lovastatin). The FDA generally follows the advice of its committees.

The lopsided vote does not reflect the difficulty of the decision the panelists wrestled with during the two-day hearing, as officials from Merck & Co. and Johnson & Johnson presented the case for OTC sales of Mevacor for people with certain risk factors for heart disease.

"At times I've thought [statins] should be in the drinking water," said panel member Frank F. Davidoff, MD, editor emeritus of the Annals of Internal Medicine. Dr. Davidoff praised the pharmaceutical companies for bringing the matter forward, but he ultimately voted against their proposal. "While OTC statins may be the right thing to do, I don't think we're there yet," he said.

While the FDA committees voted such access down, doubtless there will be an opportunity for another go-round as Bristol-Myers Squibb Co. is likely to seek approval for OTC sales of its statin Pravachol (pravastatin), in the near future.

At the heart of the panelists' Mevacor decision was their concern that approval would undermine the role that many primary care physicians play in steering patients toward healthier lifestyles as well as determining the correct dose of a statin to reduce patients' risk of heart disease.