FDA Acts on Drugs, Warns Companies

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The FDA is busy overseeing drugmakers while a government investigator says the agency is neglecting oversight of food safetyThe U.S. Food and Drug Administration over the past few days has been quite busy acting on drugs, warning pharmaceuticals over ads and asking manufacturers to investigate therapy radiation devices.

FDA Acts on Drugs

Late Wednesday, and FDA advisory panel voted against recommending approval of an experimental drug to treat chronic obstructive pulmonary disease (COPD) -- a common and deadly lung disorder. The advisors weren't convinced that the modest benefits of the drug, Daxas, from Forest Laboratories (FRX) and Nycomed, outweighed the risks, including severe diarrhea, weight loss, cancer, psychiatric problems and suicides. The panel opposed approval in a 10-5 vote.

Forest Labs shares tanked 13% Thursday because it was relying on Daxas to make up some of the lost sales it will suffer come the 2012 patent expiration for antidepressant Lexapro. Approval for a narrower group of patients may not be enough.

Meanwhile, the FDA on Wednesday approved the first generic versions of two drugs used for the treatment of high blood pressure. Teva Pharmaceutical Industries (TEVA) won most of the approvals to make generic versions of Merck's (MRK) blockbusters Cozaar and Hyzaar. The two had annual U.S. sales of about $1.3 billion in 2009.

And following its win in court over generic drugmakers Apotex and Roxane Laboratories, Teva will now have 180 days in which it can market most doses of the generic drugs exclusively before other generics can join in and push prices lower. Either way, the party is over for Merck, ready or not.

FDA Warns Companies

The FDA didn't stop with drug action. On Wednesday it posted several letters it sent last month to several pharmaceutical companies, including Gilead Sciences (GILD) and Biogen Idec (BIIB), warning them over misleading promotions for various products. Specifically, it didn't much approve of Gilead's direct-to-consumer print advertisement for its HIV drug, Truvada, and Biogen's Webcast regarding its multiple sclerosis therapy, Tysabri.

On Thursday, the FDA has sent letters to 93 device makers, including Varian Medical Systems (VAR), Siemens (SI) and GE Healthcare (GE) after it received nearly 1,200 complaints in the past decade about excess radiation from devices that treat cancer through radiation therapy. The FDA asked the companies to investigate the causes of such failures.
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