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FDA Mulls Easier Access to Cholesterol Drugs

And no drug discussion would be complete without a financial component. Companies have an incentive for seeking OTC status for prescription drugs that are experiencing weakening sales and/or generic competition. This way, companies can use their brand names to capture some sales that would have been lost.

Mevacor's U.S. sales have virtually disappeared due to generic competition. Pravachol, which ranks third in U.S. statin sales, will lose its U.S. patent protection in April 2006.

For the week ended Nov. 12, Pravachol had a U.S. dollar market share of 11.9%, or $39.2 million, according to NDCHealth, a health care information company. The market leader is Pfizer's (PFE) Lipitor, with a 49% market share, followed by Merck's Zocor, with 25.2%. Zocor, which has lost patent protection in some foreign markets, will be hit by generic competition in mid-2006.

For the week ended Nov. 12, Mevacor had U.S. sales of only $233,314 compared with sales of $13.8 million for generic versions, says NDCHealth. The firm tracks drugs that are dispensed in retail outlets and by mail-order pharmacies. The dollar amounts represent the estimated cost incurred by the wholesaler to purchase product from the drug manufacturer.

Pros And Cons

One way to examine the OTC statin debate is to compare dueling editorials by The Lancet, which opposes nonprescription statins and The American Journal of Cardiology, which says they could provide a benefit.

Shortly before Merck and J&J began selling an OTC version of Zocor in the U.K., The Lancet attacked the British government's decision for becoming the first country to allow a nonprescription statin. It argued that the government failed to require adequate tests on patients who self-medicate and to secure proof that people wouldn't simply "substitute drug use for lifestyle modification," such as losing weight and stopping smoking.

"Will pharmacists have the time to determine the individual's risk of coronary heart disease before selling the drug and also give lifestyle advice?" the editorial asked. "All these are unknowns, which is unfortunate for the U.K. public, who will be the guinea pigs in this large-scale OTC experiment."

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