A US Food and Drug Administration advisory committee on Friday knocked back Merck & Co’s bid to win over-the-counter approval of its cholesterol-lowering product, Mevacor (lovastatin), after raising doubts over whether patients would be able to take the product safely without a doctor’s input.
The committee rejected the proposed approval of Mevacor Daily by a resounding 20 votes to three majority, saying it felt that Merck’s proposed system was not adequate for patients to make appropriate assessment about whether they require a cholesterol-lowering drug that would be used on a chronic basis.
Although the drug’s safety is not in question, many committee members felt that patients would be better served by a system that provides more guidance – either from a doctor or pharmacist. Many committee members said they would have backed non-prescription status had there been a behind-the-counter option as in the UK, where an OTC statin has been available for several months but patients must first undergo an on-the-spot health check at pharmacy, including questions concerning a patient’s medical history and a range of tests [[30/07/04a]], [[18/11/03b]]. “I think it is the right thing to do, but I don’t think we are there yet,” committee member, Frank Davidoff, of the Annals of Internal Medicine, commented.
The committee rejection did not come as a surprise after documents released ahead of the meeting suggested that agency believed that the proposed label would need “major revisions and re-testing to assure better consumer understanding” [[13/01/05d]]. An earlier OTC switch proposal for Mevacor was similarly rejected in July 2000.
- Meanwhile, the FDA has set February 16, 17 and 18 as the dates when its Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee will convene to discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 drugs and selective non-steroidal anti-inflammatories [[20/10/04c]]. The meeting comes in the wake of Merck’s withdrawal of its painkiller, Vioxx (rofecoxib) [[01/10/04a]], and other clinical trial result that have since cast doubt over these products [[21/12/04a]].