Merck is seeking to overcome doctor opposition to sell the first non-prescription version of a cholesterol pill that lost patent protection six years ago.
The drugmaker is pressing the U.S. Food and Drug Administration for the third time in a decade to make Mevacor, a cholesterol-lowering medicine prescribed 15 million times last year, available on drugstore shelves. Mevacor, sold as a generic medicine since 2001, is part of a class of drugs known as statins, the most frequently prescribed type of medicine in the U.S.
The FDA is unlikely to approve nonprescription Mevacor in the face of the concerns raised by the 250,000-member American Medical Association, said Michael Obuchowski, a health-care investor with Altanes Investments LLC in New York. Patients need a physician's help to determine if they have high cholesterol and whether they can take Mevacor safely, the AMA said in a Nov. 28 letter to the FDA.
``This is serious medication, not the kind you want to be taking over-the-counter on your own,'' said Steven Nissen, head of cardiology at the Cleveland Clinic, in an interview. ``Unlike a headache, high cholesterol doesn't have any symptoms, so how do you know you have high cholesterol, or if it has improved, without going to a physician?''
A panel of advisers to the FDA will hear arguments and make a recommendation on Dec. 13.
More from Shannon at Bloomberg
Insider's view: Simvastatin went OTC in the UK with no problems, other than poor sales!
No comments:
Post a Comment