Grieving Families Blame Heparin for Deaths

Deborah M. Autor, director of the FDA's Center for Drug Evaluation and Research's Office of Compliance expressed confidence in that effort. But Stupak said without immediately recognizing the names of the 12 companies still in the contaminated heparin supply chain, officials monitoring heparin at the border would be ineffective.

Meantime, the Hubley family, too, told lawmakers heparin was responsible for their losses.

Leroy Hubley, also from Toledo, lost both his wife, Bonnie, and his son, Randy, after they received heparin during dialysis for a genetic kidney disease. Bonnie Hubley died in December 2007 and Randy died in January 2008. Both experienced symptoms associated with the contaminated heparin after receiving Baxter's heparin. Other members of the Hubley family continue to receive dialysis for their kidney disease.

"As a nurse, I thought that I would be there to save my husband from any errors, but I guess I was naïve," Randy Hubley's wife, Colleen Hubley, a dialysis nurse, told lawmakers. "I never thought the lifesaving medication we were relying on might be contaminated."

Last week, the same panel blasted FDA Commissioner Andrew von Eschenbach in regard to contaminated heparin at a hearing on the broader issue of the agency's foreign drug-inspection program.

Though estimates suggest more than 80 percent of all active ingredients used by U.S. drug manufacturers come from abroad, the FDA only inspects foreign drug plants about once every 13 years, according to the Government Accountability Office.

The GAO finds that China's drug plants are inspected once every 30 to 40 years. The FDA plans to establish permanent overseas offices in numerous countries, including China, to help address the problem.

The House Energy and Commerce panel is considering ways to better ensure that food and drug imports are safe. The panel is considering proposing that drug and drug device makers be required to register annually with the FDA. The committee is also thinking of proposing that drug labels be required to include details about drugs' country of origin, source of the ingredients and place of manufacture.

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