Department of Health and Human Services Secretary Alex Azar directed the Food and Drug Administration to investigate importing drugs in case of dramatic price hikes, according to a Thursday HHS press release.
“Health and Human Services Secretary Alex Azar requested today that FDA Commissioner Scott Gottlieb establish a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities,” the press release states.
“We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities … Safe, select avenues for importation could be one of the answers,” it continued.
A notable example of an extreme price hike was Daraprim, which helps patients with HIV prevent certain infections. Martin Shkreli, the CEO of the company that owned that sold Daraprim, raised drug’s price 5,000 percent, from $13.50 per pill to $750, in 2015. (RELATED: A Kind Of Drug That Less Than 2 Percent Of People Take Is Responsible For 40 Percent of Prescription Drug Spending)
The potential drug importation would only happen in case of a pricing emergency, leaving it on a relatively minimal scale. Importing drugs en masse would “raise additional questions about how to protect American patients,” according to the press release.
The HHS assured that imported drugs would be as safe as drugs produced in the United States. “Importation will be limited to cases where drugs can be imported with adequate assurances of safety and effectiveness.”
The working group will look at how the FDA will define dramatic price hikes, how important a potential imported drug is to public health, how drugs can be imported safely, and how to import drugs without infringing on patents and copyrights, according to a Thursday FDA press release.
Any importation would only be temporary “until adequate competition” can adjust for the price hikes, the FDA press release stated.
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