Chalk up a third strike against over-the-counter statins. Yesterday, an FDA advisory panel voted overwhelmingly against allowing Merck to sell Mevacor without a prescription. [1]
Drug makers--including Merck--have been trying for seven years to convert statins to over-the-counter status. The FDA rejected Merck's bid for OTC Mevacor in 1999 and again in 2005; officials declined to say whether they plan to try a fourth time.
At issue was whether the average Joe or Jane can safely self-medicate [2] with a statin. Yesterday, Merck presented a study showing that almost three-fourths of consumers could. But the one-fourth remaining included patients at risk of serious side effects. Of course the fat lady--er, the FDA itself--hasn't sung yet. But the agency usually does take its panelists' advice. A decision is expected in late January.
- see the statement [3] from Merck
- read the report [4] from the Chicago Tribune
ALSO: Merck's CEO defines the perfect biotech buyout. Report [5]
Related Articles:
FDA unsure consumers can self-Mevacor. Report [2]
Merck faces fierce debate on OTC statin. Report [1]
GSK buys OTC rights to Merck statin. Report [6]
Switching to generic statins not so healthy. Report [7]
Links:
[1] http://www.fiercepharma.com/story/merck-faces-fierce-debate-on-otc-statin/2007-12-10?utm_medium=nl&utm_source=link
[2] http://www.fiercepharma.com/story/fda-unsure-consumers-can-self-mevacor/2007-12-12?utm_medium=nl&utm_source=link
[3] http://www.fiercebiotech.com/press-releases/press-release-fda-advisory-panel-recommends-against-approval-mercks-nda-non-prescript
[4] http://www.chicagotribune.com/business/chi-fri_cholesterol_12.14dec14,0,5141925.story
[5] http://www.fiercebiotech.com/story/merck-chief-defines-perfect-biotech-buyout/2007-12-13
[6] http://www.fiercepharma.com/story/gsk-buys-otc-rights-merck-statin/2007-11-27
[7] http://www.fiercepharma.com/story/switching-generic-statins-not-so-healthy/2007-09-05