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U-S Senate Panel to Consider Imported Prescription Drug Safety

August 5, 2011

FRANKFORT, Ky. - Some of the drugs Kentuckians buy from their local pharmacy may come from rarely-inspected factories in foreign countries, as U.S. drug companies increasingly outsource their manufacturing. A report from the Pew Health Group urges that the Food and Drug Administration be given more teeth to regulate imported drugs.

Tainted blood thinner made in China was shipped nationwide in 2007, and dozens of patients were sickened or killed. Alan Caukell, director of medical programs at Pew Health Group, says the FDA was set up to regulate a domestic industry and doesn't have much of a presence in other countries.

"In the case of drugs, though, you can't take it out of the bottle and look to know it's safe, so you've got to have a regulatory agency and the manufacturers taking the right steps to make sure it is what it's supposed to be."

Pharmaceutical companies are importing more drugs and raw materials to cut costs, he says.

"But it does mean that there are risks, because it's occurring outside of FDA supervision and where the companies themselves can't easily check on quality."

According to a Government Accountability Office report, Caukell says, it can take up to nine years for the FDA to inspect facilities outside the United States.

The U.S. Senate's Committee on Health, Education, Labor and Pensions is considering giving the FDA more resources.

The Pew report is online at prescriptionproject.org.

Renee Shaw, Public News Service - KY