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Senate Committee to Consider Imported Prescription Drug Safety

August 5, 2011

LAS VEGAS - There's a chance that some of the medications you buy from your local Nevada pharmacy come from rarely-inspected factories in foreign countries, as U.S.-based drug companies increasingly outsource their manufacturing. Nearly half of the manufactured medicines and 80 percent of the raw materials to make them come from overseas.

It is a trend prompting concerns about the potential for contaminated, counterfeit or substandard drugs reaching the American market. In 2007, a tainted batch of the blood thinner Heparin was made in China and shipped nationwide, and dozens of patients were sickened or killed.

A report from the Pew Health Group calls for the Food and Drug Administration (FDA) to do more to regulate imported drugs. Alan Caukell, Pew Health Group director of medical programs, says the FDA was set up to regulate a domestic industry and doesn't currently 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 its 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 U.S. Senate Committee on Health, Education, Labor and Pensions is considering giving the FDA more regulatory resources; its chairman has promised hearings on the imported drug problem this fall.

Caukell adds the reason pharmaceutical companies are importing more of their drugs and raw materials is to cut costs.

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

He says a U.S. Government Accountability Office report indicates it can take up to nine years for the FDA to inspect facilities located outside U.S. borders.

The Pew report is online at http://prescriptionproject.org/after_heparin_report.

Mike Clifford, Public News Service - NV