Feminists Demand Affordable Anti-Cancer Drug, Take On Pharmaceutical Manufacturer

December 3, 2001

Women stricken with breast and ovarian cancer received a boost today with the announcement of a campaign to help assure their continued access to a generic version of the anti-cancer drug paclitaxel, marketed under the brand-name Taxol. Led by the National Organization for Women, Business and Professional Women USA (BPW), American Medical Women's Association, the SPAN (Stop Patient Abuse Now) Coalition, and the Women's Research and Education Institute, the campaign is directing support to the Food and Drug Administration to keep the lower-cost generic on the market.

"After the FDA approved a generic Taxol, the price of this life-sustaining drug dropped to less than half of what the brand-name had cost," said NOW President Kim Gandy. "We will do everything in our power to support the FDA in keeping the generic on the market."

Recently a three-judge panel of the Circuit Court of Appeals for the District of Columbia reversed a trial court order that had cleared the way for approval of generic paclitaxel. The coalition effort announced today is urging the FDA to seek reconsideration of the appellate court decision.

"Desperately ill patients could be deprived of affordable treatment if the Court of Appeals' decision is not reversed," said Dr. Jane Smith, BPW Chief Executive Officer. "It's long past time for Bristol-Myers Squibb, the manufacturer of Taxol, to stop its manipulation of the judicial and regulatory systems in order to maintain its monopoly pricing, reported to be as high as $20,000 per patient per year. We are also asking Congress to close the loopholes in the Hatch-Waxman Act that Bristol-Myers has exploited," said Gandy.

The coalition is circulating for signature a letter to the FDA urging the agency to take every step possible to ensure that the generic paclitaxel remains available. It is seeking support from women's, consumer, medical and health groups. Coalition members are also considering filing an amicus brief with the Court of Appeals emphasizing the public interest in reconsideration of the decision.

Also today a hearing on a motion for summary judgment on a related case gets underway in Los Angeles. American BioScience, a small California company that claims its patent is infringed by the generic paclitaxel, filed suit against the generic manufacturer Baker Norton Pharmaceuticals, Inc. a wholly owned subsidiary of IVAX Corporation. If the patent is found to be invalid or not to be infringed by Baker Norton Pharmaceuticals' generic paclitaxel, the decision by the DC Circuit Court of Appeals would become moot.

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