FDA unsure consumers can self-Mevacor

No crystal ball here: In reviewing Merck's application to convert Mevacor to over-the-counter [1], FDA staff said it wasn't clear whether consumers could use the statin safely and effectively. But the agency didn't say consumers clearly couldn't, either.

Tomorrow, an FDA advisory panel is set to hear Merck's app, its third attempt to get permission to sell Mevacor to patients without a prescription. GlaxoSmithKline has bought OTC rights to the drug [2], so GSK would market it and Merck reap the royalties.

Among the data Merck plans to present tomorrow is a new study that shows 72 percent of 1,499 consumers could correctly decide whether the drug was right for them. A small percentage of women under 55 and another group of patients at low risk of heart disease incorrectly said they should take the drug. Meanwhile, 30 percent of people with diabetes, with a history of stroke or with heart disease wanted Mevacor--and those patients should be managed by a doctor. More to come tomorrow.

- see the FDA briefing document [3] (.pdf)
- check out Merck's briefing info [4] for tomorrow's meeting (.pdf)
- read the article [5] from the Wall Street Journal

Related Articles:
Merck faces fierce debate on OTC statin. Report [1]
GSK buys OTC rights to Merck statin. Report [2]
Switching to generic statins not so healthy. Report [6]