FDA Panel Rejects Merck Statin Mevacor

An FDA advisorypanel on Thursday voted 10-2 against recommending that Merck'scholesterol drug Mevacor be granted over-the-counter status, the Philadelphia Inquirer reports. Although FDA is not boundby its advisory panels' recommendations, it usually follows them (Stark, PhiladelphiaInquirer, 12/14). The decision marks the third time that an advisorypanel has rejected such a request from Merck, the Wall Street Journalreports. The panel said it is unclear whether consumers would use the drugcorrectly without guidance from their physicians (Wilde Mathews, WallStreet Journal, 12/14).

The panel was concerned by a study of 1,500 people that found about one-quarterof them would take the pills even though they were not at a high enough risk ofheart disease to require the medication, needlessly exposing them to possibleside effects, the AP/Long Island Newsday reports (Neergaard, AP/Long Island Newsday,12/13). Side effects for long-term use of statins include liver problems,muscle pain and weakness, according to the Newark Star-Ledger (Cohen, NewarkStar-Ledger, 12/14). Thestudy also found that 30% of high-risk patients -- who should be monitored by aphysician -- wanted nonprescription Mevacor. In addition, the proposed OTCMevacor is less potent than some prescription statins. More than half ofpatients taking statins said they would switch to the weaker, nonprescriptionversion if it were available, which could expose them to health risks.

Merck argued that making a lower-dose statin available without a prescriptionwould help people with moderately high cholesterol control their condition. Thedrug maker also said that among high-risk patients who should be monitored,some are not under a physician's care to begin with, so OTC Mevacor would helpthem prevent heart attacks. "This is a real opportunity," EdwinHemwall, executive director of Merck's worldwide OTC regulatory and scientificaffairs, said. He added, "We are disappointed. We felt we presented a compellingcase" (AP/Long Island Newsday, 12/13).

Blow for StatinManufacturers

The panel heard testimonyfrom doctors and received letters from groups including the American Medical Association stating that consumers do not havethe capacity to self-medicate with statins and that doing so could cause risksto their health. Physicians said that patients with high cholesterol need toundergo blood tests to monitor their levels and that they should visit a doctorevery six months.

The decision is a "severe blow to a seven-year push by Merck and otherdrug makers to put statins, the world's top-selling class of drugs, next toaspirin and other over-the-counter medications on retail pharmacyshelves," the Chicago Tribune reports (Japsen, ChicagoTribune, 12/14). According to the Journal, the "10-2vote leaves little hope Merck can win regulatory approval." The decisionalso is a disappointment for GlaxoSmithKline, which bought rights to market thedrug without a prescription in the U.S. (Wall Street Journal,12/14). Some drug industry analysts said that making Mevacor nonprescriptioncould increase sales to between $200 million and $300 million annually (NewarkStar-Ledger,12/14).

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