Merck & CoInc's third bid forOTC sales of thecholesterol-loweringdrug Mevacor(lovastatin) wasrejected by FDAadvisors. The company had previouslytried for OTC sales in 2000 and 2005.
Too many of the wrong individualswould use the drug if it no longerrequired a prescription, FDA advisorsconcluded in a 10-2 vote December13, 2007, against OTC sales. "Thepatients couldn't figure out whetherthe drug was for them," commentedone FDA advisor, William Shrank, MD.
The advisors also were surprised bythe results of a study of almost 1500potential patients who wanted to purchasethe drug even though they werebad candidates. Of the participantswho wanted the medication, 25% didnot have enough risk of heart diseaseto qualify. The patients (30%) at veryhigh risk wanted Mevacor; these arepatients who should be under the careof a physician.
Still, >30% of patients already takingthe prescription cholesterol-loweringdrug said they wanted an OTC version.Half of the group said they would stopthe more potent drug in favor of lowdoseMevacor. To the agency's advisors,it raises questions about previouslyprotected patients setting themselvesup for a heart attack.
Merck's Edwin Hemwall, PhD, executivedirector for the company'sworldwide nonprescription regulatoryand scientific affairs, said after themeeting, "We are disappointed. Wefelt we presented a compelling case."
The FDA is not required to follow itsadvisors' recommendations but usuallyfollows them.