/* mobile /* end mobile MEDDESKTOP: You might be able to eat that Bacon, Merck is seeking Approval to sell a Cholesterol-lowering Drug without a Prescription.

Monday, October 22, 2007

You might be able to eat that Bacon, Merck is seeking Approval to sell a Cholesterol-lowering Drug without a Prescription.

WASHINGTON -(Dow Jones)- Merck & Co. (MRK) is pushing forward with another bid to seek Food and Drug Administration approval to sell a cholesterol-lowering drug without a prescription.

The FDA said Monday it would convene a joint advisory panel meeting to consider the proposal on Dec. 13. Specifically, Merck is asking the FDA to sell switch a 20 milligram dose of Mevacor from prescription to over-the-counter status. Mevacor was approved as a prescription drug in 1987.

In January 2005 another FDA panel rejected a bid by Merck and then partner Johnson & Johnson (JNJ) to sell Mevacor without a prescription. The panel was concerned consumers wouldn't correctly use the drug and suggested the FDA needed to establish a "behind-the-counter" system where a drug could be dispensed by a pharmacist who could make sure consumers fit the criteria to use the drug.

The FDA is considering establishing such a behind-the-counter drug system and is holding a Nov. 14 public meeting on the issue. However, establishing a new system will require the FDA to establish new rules through the federal rule- making system, a process that takes several months to years to complete.

Ron Rogers, a Merck spokesman, confirmed the company is trying again to switch Mevacor from prescription to over-the-counter status, but this time without Johnson & Johnson as a partner. He said the company is in discussions with several potential partners to sell Mevacor without a prescription.

The FDA has allowed the switch of some types of drugs including products used to treat heartburn and to treat certain vaginal infections.

However, the FDA panel that considered Mevacor in 2005 said they were concerned if Mevacor were widely made available to consumers, that many of them would incorrectly use the medication, based on data submitted by the companies. There were also concerns that people who shouldn't use the drug, such as those with liver disease or women who might become pregnant, might do so.

Rogers said the company will be submitting additional data to address some of the concerns raised at the last FDA panel meeting.

"We are optimistic and hopeful we'll be successful this time," Rogers said.

Merck made a similar proposal to sell a 10 milligram dose of Mevacor without a prescription, but the FDA rejected that plan in 2000 and said the companies needed to submit more data about consumer use.

- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com.

  (END) Dow Jones Newswires
10-22-07 1408ET
Copyright (c) 2007 Dow Jones & Company, Inc.

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