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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 | A version of this story appeared in Volume 96, Issue 31

 

Structure of pyrimethamine.

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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