Merck & Co will have to demonstrate that its cholesterol-lowering agent, Mevacor (lovastatin), can be used safely without a prescription in order to win US Food and Drug Administration clearance as an over-the-counter product, an FDA advisory committee revealed yesterday.

In briefing materials released ahead of this week’s meeting to discuss whether to recommend giving the product the green light, the panel questioned whether the self-management system Merck had used in its studies was adequate, and whether it should be a condition of approval. Since most consumers in the study “were not able to follow directions when selecting the product for their own use,” the FDA said, “the proposed label will need major revisions and re-testing to assure better consumer understanding.” It also questioned how Merck would guarantee the presence of medical staff and cholesterol testing in pharmacies where the product would be sold.

The committee will also assess whether the risks of muscle- and liver-related side effects associated with the use of drugs belonging to the statin class of drugs outweigh the lipid-lowering benefits.

Another Merck statin, Zocor (simvastatin), has been available in the UK since July 2004 [[30/07/04a]]. However, its approval faced stinging criticism from The Lancet [[21/05/04b]], and the Consumers’ Association [[14/05/04d]], which said the UK public was being used as guinea pigs in a large-scale experiment designed to lessen the burden of cost on the UK Government. The US knocked back an application for OTC Zocor in the 1990s.