Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Susan Haigney

-The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter (OTC) use of “Mevacor” (lovastatin) 20 mg. FDA’s letter indicates a revised label would be required as well as additional data from Merck. 

This decision follows the FDA’s Nonprescription Drugs Advisory and Endocrinologic and Metabolic Drugs Advisory committees’ recommended 

.  Edwin L. Hemwall, PhD, Merck’s Vice President of Global OTC Regulatory and Scientific Affairs, said the company is “evaluating the conditions outlined in the agency’s response to determine a path forward for ‘Mevacor’ OCT.”

Under review by FDA since 1999, not approvable letters were also issued in 2000 and 2005. “Mevacor” is designed to reduce LDL cholesterol levels in patients.

Articles

The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter use of "Mevacor" (lovastatin) 20 mg.

FDA Again Denies Merck’s Request for OTC “Mevacor”

-Congressmen John Dingell (D-MI) and Bart Stupak (D-MI) have requested that the Government Accountability Office (GAO) perform an updated assessment  in response to the US Food and Drug Administration’s potential development of a new class of behind-the-counter (BTC) drugs, according to the Jan. 21 edition of 

In a letter to GAO Comptroller General David Walker, the congressmen requested that more information be gathered in order to assess the benefits, risks, and general necessity of any new class of BTC drugs. In an August 1995 report,  GOA evaluated the experience of other countries with  BTC drugs, and found insufficient evidence  to support the establishment of a new class of BTC drugs in the United States. The US representatives’ letter to  Walker suggested that  the gathering of new data was necessary; however, the new report would not have to include an investigation of other countries with similar BTC drug programs. 

, the potential new class of drugs being evaluated by FDA would be those drugs deemed to not require a doctor’s prescription but would need the approval of a pharmacist to purchase. Although no FDA proposal has been presented regarding the creation of a new class of BTC drugs, opponents suggest the new class may raise drug costs. Supporters of BTC drugs suggest that today’s patients are more informed about their health and that an individual’s access to drugs would improve without the need of a doctor’s prescription.

The potential new class of BTC drugs could include oral contraceptives, over-the-counter children’s cough and cold medicines, Tamiflu, and epinephrine injections.

Rep. Dingell is the Chairman of the House Committee on Energy and Commerce and Rep. Stupak is the Chairman of the Oversight and Investigations Subcommittee.

Congressmen John Dingell and Bart Stupak have requested that the Government Accountability Office perform an updated assessment report in response to the US Food and Drug Administration?s potential development of a new class of behind-the-counter drugs.