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FDA panel nixes proposal for OTC cholesterol medication

The advisory board to the FDA voted down Johnson & Johnson-Merck Consumer Pharmaceuticals Co. application to permit the over-the-counter sale of Mevacor®. The panel’s vote was 20-3 against the application. Many reasons were cited by the advisors for voting down the application. One reason included that patients who opted to take Mevacor® did not meet the requirements of the label. Another reason dealt with safety issues dealing with statin therapy in unknown pregnancy in females (statins have been known to be teratogenic to the fetus). Finally, it was pointed out that only 10% of the patients who used Mevacor® in a mock pharmacy study fit the guidelines of the label to use the product.

Although the FDA does not need to accept the advisory boards recommendation, there have been very few times the FDA has not accepted the board’s recommendation. Many board members suggested an alternative plan to making “statins” more accessible to the mass public which is similar to a program that has been implemented in England. This program states that a patient could receive the “statin” only after consulting with a pharmacist. However, in order to accomplish this, FDA officials said that changes to existing law would need to be undertaken.

The Associated Press. The New York Times. 2005 Jan 14. www.nytimes.com [Accessed 2005 Jan 14].

Kris Chiplinski, PharmD. Candidate