F.D.A. Broke Its Rules by Not Inspecting Chinese Plant With Problem Drug

WASHINGTON, Feb. 14 — The Food and Drug Administration violated its own policies when it approved for sale a crucial blood-thinning drug without first inspecting a Chinese plant which, along with a plant in Wisconsin, made the drug’s active pharmaceutical ingredient.

“It was obviously a glitch” that the drug, heparin, produced and sold by Baxter International, was approved for sale without a plant inspection, said Karen Riley, an F.D.A. spokeswoman. The agency does not know who was at fault, and it is still “preparing to send inspectors over there,” Ms. Riley said.

Peter Barton Hutt, a former top lawyer for the agency, said that since 1980 it has had a policy requiring that plants be inspected before drugs are approved for sale.

Representative Bart Stupak, Democrat of Michigan and chairman of a House investigative subcommittee, said that no matter what happened with the heparin inquiry, the F.D.A.’s inability to provide basic information about the Chinese manufacturing plant weeks after concerns were first raised was deeply troubling.

“They can’t tell us if they’ve inspected this plant, what other problems might have been identified at this plant, or what other U.S. firms might be getting supplies from this plant,” he said.

Mr. Stupak’s committee and Senator Charles E. Grassley, Republican of Iowa, both sent letters to the agency on Thursday, asking for more information about inspections of plants making heparin.

Baxter International announced on Monday that it was suspending sales of its multidose vials of heparin after four patients died and 350 suffered complications, many of them serious. Baxter bought the active ingredient for this product from Scientific Protein Laboratories, which has plants in Waunakee, Wis., and Changzhou City, China.

http://www.nytimes.com/2008/02/15/washington/15fda.html?ref=us

F.D.A. Broke Its Rules by Not Inspecting Chinese Plant With Problem Drug

F.D.A. Broke Its Rules by Not Inspecting Chinese Plant With Problem Drug

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