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U.S. to seek tougher law on fake drug ingredients
WASHINGTON (Reuters) -- The Justice Department Tuesday is set to propose toughening federal law to help officials keep fake, internationally-made pharmaceutical ingredients out of products sold on the U.S. market.
About 80 percent of the active ingredients in U.S. prescription drugs are made overseas. The House Commerce Committee has been investigating reports that counterfeit ingredients may have injured or killed U.S. patients and questioning what officials have been doing to stop it.
Prosecuting makers and traffickers of fake ingredients often is difficult because evidence is located overseas, Deputy Assistant Attorney General Patricia Maher said in testimony provided to a House Commerce Committee panel.
But prosecution would be "greatly aided" by strengthening the law that governs safety and effectiveness of drugs, Maher said.
Changes should "make explicit what is now implicit -- that foreign companies and individuals who manufacture or distribute drugs and drug components for use in the United States" are subject to the law, known as the Food, Drug and Cosmetic Act, Maher said.
Maher is scheduled to testify at a hearing Tuesday along with Food and Drug Administration Commissioner Jane Henney, U.S. Customs Service Commissioner Raymond Kelly and others.
Officials also may be questioned about legislation moving quickly through Congress to allow U.S.-made medicines to be re-imported from other countries where they are sold at lower prices. Some opponents have said the practice may be unsafe.
At a hearing last June, an FDA official said the agency does not know how often counterfeit ingredients make their way into U.S. products but that the vast majority of imported bulk drugs are safe and effective.
In her testimony, Maher also suggested that Congress ensure that the FDA maintains authority to inspect overseas manufacturers and strengthens requirements that producers provide certain records during the inspections.
"These proposals seem reasonable in concept and I support them," Virginia Republican Tom Bliley said in a statement. Bliley chairs the House Commerce Committee.
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