Grassley Says Hold on Imported Blood Thinner Component Underscores Questions About FDA Foreign Inspections

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GRASSLEY SAYS HOLD ON IMPORTED BLOOD THINNER COMPONENT UNDERSCORES QUESTIONS ABOUT FDA FOREIGN INSPECTIONS

Senator Chuck Grassley is asking questions about whether deficiencies at a Chinese manufacturing plant that's never been inspected by the Food and Drug Administration could be behind adverse reactions in hundreds of U.S. consumers to the blood thinner heparin, for which production was suspended this week by the drug maker. The active ingredient in heparin is produced at the plant in question.

Grassley's inquiry today follows on a letter he sent earlier this month to the Food and Drug Administration about where the agency has targeted its foreign inspections of pharmaceutical plants around the world.

"The heparin case illustrates perfectly the questions about how the Food and Drug Administration is conducting foreign inspections of pharmaceutical plants worldwide," Grassley said. "It doesn't make sense that the vast majority of inspections are happening in places that aren't where the vast majority of drug products coming into the United States are made. The Food and Drug Administration clearly has a demanding and high-stakes job in verifying the safety of prescription drugs that come from all over the world. Smart and appropriate use of its drug-safety resources is essential to public safety."

Grassley is Ranking Member of the Senate Committee on Finance, which has legislation and oversight responsibility for the Medicare and Medicaid programs. He has conducted extensive oversight of the U.S. drug safety system.

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