FDA advisers again reject nonprescription lovastatin

Abstract

For the third time in less than a decade, FDA advisers have recommended that the agency reject an application from Merck & Co. Inc. to market a nonprescription version of the cholesterol-lowering drug lovastatin. “It seemed to me that patients couldn’t figure out who the drug was for and if the drug was for them,” said internal medicine specialist William H. Shrank, of Boston’s Brigham and Women’s Hospital, in describing data presented December 13, 2007, in Silver Spring, Maryland. Shrank, a recently appointed member of FDA’s Nonprescription Drugs Advisory Committee, was 1 of 10 experts who voted against the proposal to make lovastatin 20-mg tablets available without a prescription. The meeting also included participants from FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. Two advisers voted in favor of FDA approval of the application, and one abstained from voting. Shrank’s criticism was shared by many of the advisers and echoed concerns raised nearly three years ago when members of the two committees overwhelmingly voted against Merck’s previous application to market nonprescription lovastatin (see March 1, 2005, AJHP News).