FDA panel refuses to allow Merck to sell statins over the counter

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon
Source: CBS News

The FDA’s joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted (10-2) late yesterday against recommending approval at this time of the over-the-counter (OTC) use of Mevacor (lovastatin) to help lower LDL cholesterol.

"We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.

Most committee members said the drug was generally safe, but raised concerns that consumers might be subject to excess usage and uninformed consumption without a prescription.

The FDA is not bound by the committee's vote, but usually follows its recommendations. The anticipated action date by the FDA is Jan. 26, 2008.

If the FDA does not follow the advice of the panel, Mevacor would be the first statin to be sold OTC. The American Medical Association has also openly opposed Merck’s application for nonprescription sales.

The Centers for Disease Control and Prevention (CDC) released its cholesterol report yesterday morning that states the U.S. cholesterol level has fallen to the ideal range of 199, in comparison to 222 in 1960 when the survey began. The CDC attributes the improvement to anti-cholesterol drugs—statistics that did not assist Merck’s influence with the FDA yesterday.

The rejection thwarts efforts by Merck and its marketing partner, GlaxoSmithKline, to increase profits with an OTC Mevacor. The current sales of prescription statins total more than $16 billion a year in the United States alone, according to the Chicago Tribune.