FDA Advisory Committees Oppose OTC Status For Statins

Main Category: Statins
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Dec 2007 - 2:00 PDT

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Two Food and Drug Administration advisory committees recommended that the agency not approve over-the-counter status for lovastatin 20 mg (Mevacor).

During the joint meeting of the Nonprescription Drug Advisory Committee and the Endocrinologic Drugs Advisory Committee ASHP voiced its opposition to the proposal, focusing its comments on the ongoing need to evaluate effectiveness and safety.

"Use of statins requires ongoing vigilance, said Cynthia Reilly, ASHP director of clinical standards and quality. "The existing model for OTC medications would place the entire burden for performing these functions on the patient and would likely result in increased adverse drug events."

This was the third review of the application for nonprescription status for lovastatin. A major focus of this meeting was proposed revisions to the labeling that were intended to improve consumer's ability to whether the therapy is appropriate and to enhance the pregnancy and myopathy adverse event warnings. Previous meetings were held in 2000 and 2005.

To read Reilly's testimony, click here.

http://www.ashp.org

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