FDA panel says no to selling cholesterol drugs over counter

CHICAGO TRIBUNE

CHICAGO — Consumers will still need a doctor’s prescription for cholesterol-lowering drugs, advisers to the U.S. Food and Drug Administration ruled Thursday.

By a 10-2 vote, FDA’s panel of outside advisers denied drug giant Merck & Co.’s third bid to sell Mevacor as an over-the-counter medication. Merck declined to say whether it will come back a fourth time. The FDA usually follows the advice of its panels.

“We are disappointed in today’s outcome,” said Edwin Hemwall, Merck’s vice president, Global OTC Regulatory and Scientific Affairs.

The panel’s vote is a severe blow to a seven-year push by Merck and other drug makers to bring the world’s top-selling class of drugs to retail pharmacy shelves, next to aspirin and other over-the-counter medications.

The so-called statins that include Lipitor and Crestor and generics such as simvastatin, branded as Zocor, and lovastatin, also known under the Mevacor brand, help lower LDL (or “bad cholesterol”) that makes up the bulk of a person’s cholesterol level. The doctor-recommended level is below 200, a marker deemed achievable thanks to the help of statins. The FDA panel heard testimony from influential doctors and received letters from physician groups such as the American Medical Association, which contended that consumers’ ability to self-medicate with statin drugs could be putting their health at risk to dangerous side effects.