Third time's the charm? Merck is going to the FDA again, hat in hand, asking for approval to sell the statin drug Mevacor over the counter. Twice before, in 2000 and 2005, the answer was no. The concern apparently was that patients aren't equipped to decide whether they need statins.
This time, Merck is suggesting that two precautionary messages be added to the drug's label: Women under 55 shouldn't take it, nor should women who could get pregnant. The drug maker says new study data shows that these messages helped consumers make the should-I-statin-or-shouldn't-I choice. Still, some powerful critics will argue at the advisory panel's meeting Thursday that patients taking statins need a doctors' advice and oversight. Meanwhile, Merck and its supporters plan to cite the "treatment gap" in heart disease. About 14 million people should be taking statins, but aren't, the company says.
We'll learn more in a couple of days when the FDA posts its background material for the meeting. Keep in mind, too, that Merck is in effect arguing on GlaxoSmithKline's behalf. The British drug maker recently inked a deal for Mevacor's OTC rights.
- see the FDA's meeting notice (.pdf)
- read the story in USA Today
- get more details from the New Jersey Star-Ledger
Related Articles:
GSK buys OTC rights to Merck statin. Report
Switching to generic statins not so healthy. Report