Abstract
Members of FDA’s Nonprescription Drugs and Endocrinologic and Metabolic Drugs advisory committees on January 14 overwhelmingly recommended against allowing Merck to market Mevacor OTC, a nonprescription 20-mg lovastatin formulation. After two days of testimony and deliberations in Bethesda, Maryland, the committee members voted 20–3 against backing the prescription-to-nonprescription switch. Committee members voiced doubts about the ability of patients to determine on their own whether they are candidates for the hydroxymethylglutaryl–coenzyme A reductase inhibitor, or statin, and to use the product safely. An FDA analysis of data from a label comprehension study conducted by Merck revealed that just 1% of consumers who believed that they could immediately begin using the product actually met the strict eligibility criteria specified in the proposed labeling. “That is of concern,” said FDA safety officer Laura Shay, who presented an analysis of the data to the two committees. FDA is expected to announce its decision in February on whether to allow Merck to market Mevacor OTC.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
