From Bloomberg: "Merck's Vioxx May Be Introduced in the U.S., FDA Panel Rules"--
Merck & Co.'s Vioxx painkiller, withdrawn Sept. 30 in the biggest drug recall ever, offers enough benefits to support its sale in the U.S., a Food and Drug Administration committee ruled today.
A panel of doctors and scientists meeting in Gaithersburg, Maryland, voted 17-16 that the benefits of Vioxx may outweigh its link to heart attacks and strokes in some patients. Panel members next will discuss how the drug should be used and what cautions should accompany the treatment if it goes back on the market.
It's an interesting development that's sure to confuse thousands. Merck has yet to say whether it will now try to reverse its voluntary withdrawal of Vioxx and get it back on the market, which will depend on whether the full FDA follows the advisory committee's recommendation. The best bet is that Merck will try to reintroduce Vioxx, though it would probably be in some restricted format, accompanied by new warnings required by the FDA. While Vioxx would no longer be a blockbuster drug, Merck wouldn't have to fight the stigma that accompanies, in jurors' minds, a drug that's been withdrawn from the market.
Stay tuned for further analysis. Collected Vioxx posts here.
UPDATE 3/1/05 Here's an intriguing New York Times article: "10 Voters on Panel Backing Pain Pills Had Industry Ties," by Gardiner Harris and Alex Berenson.
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