OTC statins vetoed again by FDA panels

Washington -- The latest effort to sell a cholesterol-lowering statin over the counter met with defeat on Jan. 14 when two Food and Drug Administration advisory panels voted jointly 20-3 against a proposal by Merck & Co. and Johnson & Johnson to sell 20 mg tablets of Mevacor directly to consumers without a prescription.

The FDA generally heeds the advice given by its panels.

Despite the lopsided vote, several panelists urged the drug companies not to give up their efforts, because the benefits of lower cholesterol levels are clear. And many who voted against the proposal said they favored an approach taken in Great Britain last year when it allowed over-the-counter sales of 10 mg of Zocor but only under the supervision of a pharmacist. The British system allows for this intermediate supervision while the FDA doesn't have that option.

Another proposal for OTC sales of a second statin is expected to be heard later this year.

The vetoed proposals are the second attempts by pharmaceutical companies to gain OTC status for their statins. Both were rejected by the FDA in 2000. OTC approval allows a manufacturer to obtain a three-year exclusive right to sell the drug.

Many of the panelists on the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee also said they thought that the drug presented such a significant danger, particularly to a fetus, that a physician's supervision should continue to be required.

Concerns were also raised about the ability of people to determine on their own whether they should take a statin. The drugs, while generally safe, can cause muscle pain and the more serious muscle breakdown rhabdomyolysis that can lead to kidney and other organ damage.

The AMA strongly opposes OTC statin sales and wrote in a letter to the FDA dated Dec. 22, 2004, that to lose the benefits of physician supervision would be detrimental to the health of many individuals.

The AMA also opposes the addition of a third class of drugs that would be controlled by pharmacists, again citing patient safety considerations.