The Trump administration wants to explore how to safely import pharmaceuticals from other countries in order to counteract major hikes in the price of drugs. Such a policy would represent a major shift from current procedure.
Health and Human Services Secretary Alex Azar requested on Thursday that the Food and Drug Administration establish a working group to examine safe importation. The request is part of a larger effort by the Trump administration to tackle high drug prices, a growing driver of healthcare costs in the U.S.
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“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,” Azar said in a statement.
He cited the case of “pharma bro” Martin Shkreli, the CEO of Turing Pharmaceuticals, who hiked the price of an anti-malarial drug Daraprim by 5,000 percent in 2015.
“Safe, select avenues for importation could be one of the answers to these challenges,” Azar said.
Right now, the FDA allows the importation of drugs that have been approved overseas, but only to ease a shortage of a drug in the U.S.
For instance, in 2013, the FDA asked a foreign company to drastically ramp up production of drugs that are a specialized form of food infused intravenously. The drugs are typically used in cases where a person can’t eat food normally.
But importation has never been allowed to address a price spike for a drug already available in the U.S.
The working group will look into how to make importation possible to alleviate sudden price spikes. HHS said in a release that the safety of the imported drugs will be a priority for the group.
This effort would be different from re-importation of drugs that have been exported to Canada and subjected to Canadian price controls, a reform popular among Democrats and some Republicans.
The FDA has been hesitant to explore re-importation because of safety concerns, specifically concerns surrounding fraudulent online pharmacies that may peddle counterfeit or substandard drugs.
Some lawmakers, such as Sen. Bernie Sanders, I-Vt., have touted re-importation as a key way of lowering drug prices, but bipartisan opposition, usually citing safety concerns, has repeatedly prevented the idea from moving forward in Congress.
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