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Court Orders Generic Breast Cancer Drug Off Market.(Brief Article)
2001 DEC 13 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration was wrong to approve a generic version of the breast cancer drug Taxol, a federal appeals court said, ordering that the generic drug be pulled from the market.
The order had not yet trickled down to the FDA, and the generic drug maker plans an appeal, so it is unclear if or when cancer patients would lose access to the cheaper version.
Taxol is one of the most widely used treatments for breast and ovarian cancer and earns manufacturer Bristol-Myers Squibb Co. more than $1 billion in U.S. sales each year.
Ivax Corp. of Miami has been selling its generic version of Taxol, called paclitaxel, for just over a year.
It was approved by the FDA despite objections from a third company, American Bioscience, Inc., which claims it holds a patent that covers the methods by which the drug is administered. If ABI's patent is valid, then Ivax could be forced to negotiate with ABI for the right to manufacture the drug.
Under federal law, the FDA cannot approve generic drugs if there are valid patent claims. Bristol-Myers Squibb's patent has expired, but ABI said it has a claim on the drug, too, and said that claim is still in force.
The FDA argued that ABI's patent claim was not filed on time and therefore is not valid. But after analyzing the complex regulatory law, the judges disagreed and said the FDA was wrong to ignore the claim.
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Source: HighBeam Research, Court Orders Generic Breast Cancer Drug Off Market.(Brief Article)