FDA Panel Rejects Merck Statin Mevacor For OTC Status

Main Category: Statins
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Dec 2007 - 10:00 PDT

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

The panel was concerned by a study of 1,500 people that found about one-quarter of them would take the pills even though they were not at a high enough risk of heart disease to require the medication, needlessly exposing them to possible side 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, Newark Star-Ledger, 12/14). The study also found that 30% of high-risk patients -- who should be monitored by a physician -- wanted nonprescription Mevacor. In addition, the proposed OTC Mevacor is less potent than some prescription statins. More than half of patients taking statins said they would switch to the weaker, nonprescription version if it were available, which could expose them to health risks.

Merck argued that making a lower-dose statin available without a prescription would help people with moderately high cholesterol control their condition. The drug 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 help them prevent heart attacks. "This is a real opportunity," Edwin Hemwall, executive director of Merck's worldwide OTC regulatory and scientific affairs, said. He added, "We are disappointed. We felt we presented a compelling case" (AP/Long Island Newsday, 12/13).

Blow for Statin Manufacturers
The panel heard testimony from doctors and received letters from groups including the American Medical Association stating that consumers do not have the capacity to self-medicate with statins and that doing so could cause risks to their health. Physicians said that patients with high cholesterol need to undergo blood tests to monitor their levels and that they should visit a doctor every six months.

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

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