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Harkin Committee to Consider Imported Prescription Drug Safety

July 22, 2011

WASHINGTON, D.C. - There's a good chance that the drugs you buy from your local pharmacy come from rarely-inspected factories in foreign countries, as drug companies based in the United States increasingly outsource their manufacturing functions.

In 2007, tainted blood thinner made in China was shipped nationwide, including to Iowa, sickening some patients and killing others. The Pew Health Group has released a report on the need to give the Food and Drug Administration (FDA) more teeth to regulate the safety and quality of imported drugs.

Sen. Tom Harkin (D-Iowa) chairs the committee that is considering giving the FDA more resources. 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."

The reason pharmaceutical companies are importing more drugs and raw materials is to cut costs, he adds.

"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."

Caukell says, according to a Government Accountability Office (GAO) report, it can take up to nine years for the FDA to inspect facilities located outside the U.S. The Pew Health Group report is online at

Dick Layman, Public News Service - IA