Court Reverses FDA Approval of Generic Version of Taxol
A Washington, D.C., federal appeals court ruled yesterday that the FDA was mistaken in allowing Ivax Corp. to produce and market a generic version of Bristol-Myers Squibb's cancer drug Taxol, the New York Times reports. A third company, Los Angeles-based American BioScience Inc., brought the suit, charging that Ivax had violated American BioScience's patent on a fast-delivery version of Taxol. The Federal District Court in Los Angeles is scheduled to hear arguments on Ivax's challenge to that patent in three weeks (Freudenheim, New York Times, 11/7). Yesterday, the U.S. Appeals Court for the District of Columbia Circuit ruled that the FDA's approval of Onxol, Ivax's generic version of Taxol, was "arbitrary and capricious" and must be "vacated." In effect, the court agreed with American BioScience, saying it was unsure how or why the FDA did not consider that company's patent an "impediment to approving Ivax's generic product" (Reuters/Wall Street Journal, 11/7). By federal law, the FDA cannot approve generic drugs if there are "valid patent claims." American BioScience maintains that its patent was "still in force" when the FDA approved Ivax's generic version (AP/Las Vegas Sun, 11/6).
Even though the court ruled that the FDA's approval of Ivax's generic Taxol be revoked, it is "unclear what steps can be taken to undo" the approval, the Newark Star-Ledger reports. Hemant Shah, an independent analyst who covers the drug industry, said, "I don't think [the FDA's approval] can be reversed. There's really nothing anybody can do" (Silverman, Newark Star-Ledger, 11/7). The New York Times reports that Ivax said it would seek to have the ruling reconsidered, calling the ruling "incorrect." But Ivax officials added that the ruling "would not prevent the company from continuing to market Onxol." Nancy Goldfarb, a spokesperson for Bristol-Myers, said, "It remains to be seen what all the implications of this court decision will be." In the meantime, the Federal Trade Commission is investigating Ivax's charges that Bristol-Myers and ABI "colluded" to keep Onxol off the market. An FDA spokesperson said the agency is "reviewing yesterday's ruling carefully" (New York Times, 11/7).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.