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Pharmaceuticals

FDA considers imports to tackle high U.S. drug prices

by Glenn Hess, special to C&EN
July 29, 2018 | APPEARED IN VOLUME 96, ISSUE 31

 

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As part of an effort to lower prescription drug prices in the U.S., FDA will explore ways to safely import pharmaceuticals in limited circumstances. A working group will evaluate how to import drugs from overseas “in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents” or other exclusive rights, FDA’s parent agency, the Department of Health & Human Services (HHS), says in a press release. HHS cites the case of pyrimethamine, an antiparasitic drug approved by FDA in 1953 and marketed as Daraprim, whose list price suddenly jumped by more than 5,000% in 2015. “Safe, select avenues for importation could be one of the answers to these challenges,” HHS secretary Alex Azar says in the release. Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor & Pensions Committee, says he supports the initiative. But the brand-name drug industry rejects the idea. “Drug importation schemes circumvent the robust safety requirements we have in United States, posing a serious public health risk and jeopardizing our secure medicine system,” says the Pharmaceutical Research & Manufacturers of America, the industry’s trade group.

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