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Jurdys Blog Monheit Law : Blog Home : January 2005 : 2005-01-13

FDA Fix No. 4: Government-Funded Studies

Studies conducted by pharmaceutical firms are more likely to show success than those funded by the National Institutes of Health or other outside institutions. Yet doctors and the U.S. Food and Drug Administration alike rely almost entirely on information from... (Read Article)


FDA mulls availability of drug for cholesterol

A Food and Drug Administration advisory panel is scheduled to recommend today whether a drug aimed at treating high cholesterol should be sold from store shelves like common remedies for headaches, colds and allergies.

Merck & Co. and Johnson & Johnson, in a joint venture, have asked the FDA to let them sell a low-dose version of cholesterol-lowering Mevacor directly to consumers.

During the first day of a two-day hearing yesterday at a Bethesda, Md., hotel, FDA drug advisers questioned whether the pharmaceutical companies compiled enough evidence of Mevacor's safety, such as for pregnant women.


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Over-the-counter sales of cholesterol drug studied

Many Americans would reduce their chances of heart disease if a cholesterol drug now available only by prescription were sold over the counter, federal health advisers were told.


But the drug also might wind up in the hands of patients who aren't supposed to take it, came the retort.




The FDA turned down a similar application for over-the-counter Mevacor in 2000.


2005-01-12 «  » 2005-01-14