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FDA foils Merck's OTC drug plan
Merck's stock holds steady after Mevacor loses second attempt at over-the-counter status.
January 14, 2005: 5:34 PM EST
By Aaron Smith

NEW YORK (CNN/Money) - An advisory panel for the U.S. Food and Drug Administration shot down an attempt by Merck & Co. Inc. to peddle a prescription cholesterol-reduction drug as an over-the-counter medication on Friday, but the company's share price scarcely budged after the announcement.

Merck spokesman Tony Plohoros said he was "disappointed" with the decision of the advisory panel, which rejected a similar attempt by the drug manufacturer in 2000, though he vowed to keep fighting.

"We are encouraged by the discussion and recognize the value of the committee reflecting a wide range of views," said Plohoros, whose company had formed a partnership with Johnson & Johnson to retail the drug. "We continue to believe in the benefits of Mevacor 20-milligram as an over-the-counter medication to keep lower cholesterol and continue to improve overall public health. We will continue to work with the FDA towards that end."

The panel voted 20-3 against approving Mevacor as an over-the-counter medication. The FDA still has the final word, but the administration generally follows the advice of its panels.

Michael Krensavage, pharmaceutical analyst for Raymond James, said the decision "will have no meaningful impact on Merck." Even if the over-the-counter deal had been accepted, Merck would have had to split its sales with Johnson & Johnson and would have had to lower prices to accommodate over-the-counter customers, said Krensavage.

The FDA's advisory panel agreed that over-the-counter Mevacor would be beneficial to its target population, but expressed concerns that pregnant women and others might expose themselves to muscle and liver damage by taking the drug, according to Reuters.

"Every drug is a balance of benefits and risks," said Robert Hazlett, pharmaceutical analyst for Suntrust Robinson Humphrey, who considers the leading cholesterol reduction drugs, otherwise known as statins, to be safe. "With any drug there are risks and you have to be careful with all these drugs in terms of liver damage. No drug is perfect. They're not lollipops."

Dr. Frank Sacks, professor of cardiovascular disease prevention at Harvard School of Public Health, said he regularly prescribes statins to patients who need more than a balanced diet and a gym membership to fight high cholesterol.

"I'm in favor of drug therapy and being aggressive with drug therapy with patients who are high risk for cholesterol," said Dr. Sacks. "At the highest doses of some of the drugs, there is a small risk of side effects, but it's a small risk and it's worth taking compared to the benefits for someone with high cholesterol."

Prior to the advisory panel's decision, Dr. Sacks warned that over-the-counter approval could lead to trouble.

"More people will take it and many people think it's the panacea, which it's not," said Dr. Sacks. "Who's going to monitor it to see if it's effective? There's no monitoring for safety."  Top of page




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