Wyeth Sues Fda to Block Competitor Generic Antibiotic
Madison, N.J.-based Wyeth filed the lawsuit in U.S. District Court in Washington, D.C., seeking a temporary restraining order and a preliminary or permanent 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. The suit also asks the court to order the FDA to withdraw its approval of Orchids products or any generic versions that arent exactly the same as Zosyn.
Wyeths head of global medical affairs, Joe Camardo, said patient safety is at stake and that Orchids product could lead to preventable medical errors.
“Over 2 million people get Zosyn in any given year,” Camardo told The Associated Press in an interview.
Many are critically ill patients with very serious infections, so hospital workers often rush to set up an intravenous line to rapidly feed in both Zosyn and, often, a standard IV solution to boost blood volume and pressure. With an older formulation of Zosyn, which Wyeth claims is what Orchid would 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 get.
“They wouldnt get the full dose,” Camardo said.
That could mean the patient doesnt get enough antibiotic to stop the infection in time.
Having two Zosyn versions in use could cause confusion when hospital workers are rushing to save very ill patients, Camardo added.
The lawsuit calls the FDAs approval of Orchids products “arbitrary, capricious, an abuse of discretion” and “unlawful.” 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.
Lawsuits by major drugmakers against the FDA – essentially biting the hand that feeds them – are relatively rare, because those companies will need the agency to repeatedly approve future products and new uses for existing ones.
Small drugmakers, with only one or two products on the market and looming generic competition putting their back to the wall, sue the FDA much more, often making long-shot arguments that the agency should require additional data or re-examine tests by the rival company to be sure its product is chemically identical, said analyst Steve Brozak of WBB Securities.
“For Wyeth to do this means that they are so comfortable with the data, they believe the FDA got it wrong,” Brozak said. “Thats what makes this different.”
Zosyn has been on the U.S. market since 1993 and had 2008 sales totaling $1.3 billion, making it the companys fifth-biggest product line.
Camardo said that Wyeth several years ago filed a “citizens petition” asking the FDA not to allow generic Zosyn because of the potential for problems. The petition laid out Wyeths scientific arguments and contained similar statements of support from outside experts on medication errors and drug interactions and effects, he said.
The FDA denied the citizens petition last Tuesday and then approved Orchids drug last Wednesday.
FDA spokesman Christopher Kelly said the agency does not comment on pending litigation.