Wyeth sues FDA to block rival generic antibiotic
September 23, 2009
According to the Associated Press, Wyeth has sued the Food and Drug Administration to block the sale of a generic rival to its intravenous antibiotic Zosyn, claiming the generic is not an equivalent product and could harm critically ill patients. The Madison, N.J.-based company filed a federal lawsuit against the FDA, seeking both a temporary restraining order and a preliminary injunction. The lawsuit seeks to prevent Orchid Chemicals & Pharmaceuticals Ltd. of Chennai, India, from selling a generic version of Zosyn that the FDA approved last week. Wyeth''s head of global medical affairs, Joe Camardo, said patient safety is at stake and that Orchid''s product could lead to preventable medical errors. The problem is that with an older formulation of Zosyn, which Wyeth claims is what Orchid will be selling, if the same IV line is used, Zosyn can mix with the intravenous solution and cause a chemical reaction that inactivates the antibiotic, limiting how much patients would get. That could mean the patient doesn''t get enough antibiotic to stop the infection. The lawsuit calls the FDA''s approval of Orchid''s products "unlawful" and "arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with the law." The approval "permits the marketing of a generic drug product that cannot be safely used in the same manner as the branded product" and "seriously endangers patient health," the lawsuit states. Wyeth discontinued the old version in October 2005, when the FDA approved a newer version that adds two ingredients to prevent the harmful chemical reaction. Zosyn has been on the U.S. market since 1993. Sales of Zosyn and Tazocin, as it''s called in other countries, last year totaled $1.3 billion. Camardo said that Wyeth several years ago filed what''s called a "citizen''s petition" with the FDA, a request asking the agency not to allow generic Zosyn because of the potential for problems. The citizen''s petition laid out Wyeth''s scientific arguments and contained similar statements of support from outside experts on medication errors and drug interactions and effects, he said. But the FDA denied the citizen''s petition and then Orchid''s drug was approved, Camardo said. The lawsuit was filed in U.S. District Court in Washington, D.C. The 33-page suit names as defendants the FDA, the U.S. Department of Health and Human Services and its head, Secretary Kathleen Sebelius, and Dr. Margaret Hamburg, commissioner of the FDA. The suit requests action by the court within 10 days because Orchid has said it plans to launch its products "immediately," Camardo said.