Pharmaceutical companies face continuing tough scrutiny from the Food & Drug Administration, a climate that could hurt growthMore than two years after Merck (MRK) pulled its Vioxx painkiller from shelves over heart attack and stroke risks, worries about drug safety continue to propel policy at the Food & Drug Administration. This is causing headaches for pharma companies that need to get new, revenue-boosting products on the market quickly. And the tenser climate could eventually lead to tougher regulations about how companies monitor the safety of their drugs once they hit the market.
Many analysts are watching closely to see how the FDA deals with Merck's latest arthritis drug, Arcoxia, which works by the same mechanism as Vioxx. The company is expected to present data to the FDA's Arthritis Advisory Committee on Apr. 12. Pushing a Vioxx-like drug is certainly controversial. But Arcoxia is already available in more than 60 countries, and in the U.S., Merck is seeking approval for a narrower set of conditions than for its notorious cousin, which was indicated to treat several ailments.
A new class of type 2 diabetes drugs designed to lower blood-sugar levels could also face heightened scrutiny. The FDA made its first ruling on this class of treatments when it approved Merck's Januvia last year. But critics have questioned whether therapies like this are really superior to what's already available. In addition, Novartis' (NVS) candidate in this class, called Galvus, has been found to cause skin lesions in monkeys, a discovery that could hold up approvals of other such drugs.
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