F.D.A. Panel Votes Against Sale of Statins Over Counter

By STEPHANIE SAUL

Published: January 15, 2005

Correction Appended

BETHESDA, Md., Jan. 14 - A Food and Drug Administration advisory panel recommended against the over-the-counter sale of a Merck cholesterol-lowering drug, saying that while millions of Americans could benefit from taking it, they should not begin such a regimen without a doctor's advice.

The F.D.A. typically heeds such recommendations, meaning that the drug industry has been at least temporarily thwarted from creating a new segment of the drug market. But Merck and its partner in the application, Johnson & Johnson, said they would continue trying to win approval.

The companies had sought to sell a nonprescription version of Mevacor, one of the oldest of the class of drugs known as statins. With the support of some cardiologists, the companies argued that over-the-counter statins could benefit many of the estimated 39 million people whose blood cholesterol might put them at moderate risk of a heart attack but who are reluctant to spend the time and money getting a doctor's prescription.

Despite the panel's lopsided vote against recommending approval - 20 to 3 - even several members who voted no said they liked the idea of selling cholesterol drugs over the counter but would need more data. An advisory panel rejected similar applications in 2000 for both Mevacor and Pravachol, by Bristol-Myers Squibb, concluding that the medical management of cholesterol should be done under a doctor's care.

An approval of over-the-counter sale of a statin might have opened the door to companies' being able to extend their exclusive rights to name-brand statins even after their patents expire and generic prescription versions enter the market. If a name-brand drug is approved for over-the-counter sale, a company has exclusive rights to sell it without competition from generic over-the-counter versions.

Mevacor, whose patent has already expired, is no longer a big seller for Merck. More important to Merck would be eventual over-the-counter approval for its Zocor, which is No. 2 in the statin market behind Lipitor, by Pfizer, which goes off patent next year. Bristol-Myers Squibb, whose Pravachol is No. 3 in sales and also goes off patent next year, said last month that it was once again planning to seek F.D.A. approval for over-the-counter sales.

But if such approval is to come, drug companies would evidently need to make a more persuasive case than Merck and Johnson & Johnson were able to muster with Mevacor.

"I think the committee was relatively comfortable with the idea that these drugs would reduce risks and would reduce the hazard of this problem," said one of the panelists, Alastair Wood, a professor at Vanderbilt University Medical Center in Nashville. "But the quality of the data supporting that was inadequate."

Several panel members said they would be more likely to approve a nonprescription statin for "behind-the-counter" sale, in which no prescription would be required but a pharmacist must approve the drug's use. Such a sales category exists in Britain but is not currently used in this country. Dr. Charles Ganley, head of the F.D.A.'s division of over-the-counter products, said Friday at a news conference after the hearing that "behind-the-counter" sales were worth exploring, but cautioned that creating that new category might require Congressional approval.

Approval of an over-the-counter statin would also represent a departure from the current system of dispensing nonprescription drugs mainly for symptomatic relief only. Some physicians had predicted that approval of an over-the-counter statin would have been the first step toward over-the-counter blood pressure and diabetes medications.

"This was the paradigm shift that said we were going to over-the-counter drugs to prevent disease," said Dr. Wood, the advisory panel's chairman, who cast one of the three votes for approval. "The reality is that the vast majority of these patients are receiving no therapy now, and should be."

The companies, which planned to market over-the-counter Mevacor 20-milligram doses, had said that the target audience was 15 million to 20 million people. They would be men 45 and older and women 55 and older, with LDL - or "bad" cholesterol - levels of 130 to 170 and at least one other cardiovascular risk factor. The company had estimated that three million to five million people would take the drug.

The panel's decision against the drug was based largely on a marketing study that the two companies submitted in support of their proposal. In that study, the companies set up 14 simulated storefront drugstores across the country where 3,316 people were given the chance to decide whether to take Mevacor without a prescription. Of those, 1,061 decided to buy it.