FDA Advisors Recommend Against Approving OTC Statin For The Third Time

This is the third time that the FDA advisory committee has rejected Merck’s proposed otc statin Mevacor application. FDA does not feel that consumers could make an appropriate self-selection decision.

The joint panel voted 10-2 with one abstention against recommending approval. It also voted 11-2 that Merck’s consumer behavior study conducted for its switch application for lovastatin 20 mg did not demonstrate consumers could make an appropriate self-selection decision.

The committees also voted strongly, 12-2, against saying that data Merck presented with its application shows the proposed label warning concerning muscle pain supports adequate consumer understanding. However, the committees voted 9-3 with one abstention that the data supports adequate consumer understanding of the label warning concerning pregnancy and appropriate self-selection by women who could become pregnant.

During the daylong advisory panel meeting, experts expressed concern about whether patients were capable of determining if they were appropriate candidates for the lipid-lowering medication. The panel members were concerned that patients who did not need the drug–those at low risk for future cardiovascular events–and those who should be under the care of a physician–those considered high risk–would inappropriately take lovastatin if it was available OTC.

"Although statins have tremendous benefits and are effective in many patients, there are risks associated with taking the wrong dosage, not adjusting the dosage after condition improvement, and not adhering to specific usage guidelines," an ACC statement issued to the press read. "Patients get the best treatment when their progress is monitored, and physician involvement is paramount in ensuring that patients receive optimal medical treatment."

The UK was the first country to introduce OTC statins, with the launch of Zocor Heart-Pro in July 2004. This product, which contains 10 mg of simvastatin, is aimed at the same group of people–those with a moderate risk of heart disease. But the switch was easier in the UK, because it has an intermediate category of medicines called "pharmacy-only medicines," which allows certain products to be bought only under the supervision of a pharmacist, who can check that they will be used appropriately.

The panel discussed Merck’s third application to switch lovastatin 20 mg for cholesterol lowering for primary prevention of heart attack, specifically for women over age 55 and men over 45 with higher cholesterol levels and heart disease risk factors.

If approved by the FDA, which is now unlikely given the recommendation of the advisory committees, lovastatin would be sold by GlaxoSmithKline, which recently licensed the US rights to OTC Mevacor from Merck. A decision from the FDA is expected in early 2008.

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