The Trump administration is exploring ways to safely import certain drugs from foreign countries, part of an effort to lower the price of prescription medicine.
The Food and Drug Administration is forming a working group to examine how the U.S. could import pharmaceuticals from abroad “in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities,” the Department of Health and Human Services said in a statement Thursday.
Opening the door to foreign drug importation, even in such limited circumstances, would represent a significant step in the administration’s efforts to lower the costs of prescription drugs.
The administration has already released a blueprint to lower prices, and officials are looking to draw recommendations from the industry. Critics of the outline have said it is light on specifics.
During the campaign, President TrumpDonald TrumpJury in Jussie Smollett trial begins deliberations Pence says he'll 'evaluate' any requests from Jan. 6 panel Biden's drug overdose strategy pushes treatment for some, prison for others MORE broke from his party and backed expanded importation of cheaper medicine. Most Republicans, including Health and Human Services Secretary Alex Azar, have traditionally opposed the idea. Azar spent 10 years as an executive at pharmaceutical company Eli Lilly.
Azar and FDA Commissioner Scott Gottlieb on Thursday stressed the working group will be narrowly focused, and any importation policies will be temporary. The group will only examine the importation of drugs not protected by patents or exclusivities.
“Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories,” Gottlieb said in a statement.
A broader focus would “raise additional questions about how to protect American patients,” and would run the risk of allowing counterfeits or other unsafe drugs getting into the U.S. supply chain, HHS said.
Limiting the scope will allow other manufacturers to introduce new competition, HHS added.
Azar pointed to recent examples of a manufacturer dramatically increasing the price for both the branded and generic version of drugs that had no patent protections.
Most notably, the company once owned by infamous “pharma bro” Martin Shkreli increased the price of Daraprim by more than 5,000 percent in 2015, even though the drug had been around for more than 60 years.
“When HHS released the President’s Blueprint for putting American patients first, I said we are open to all potential solutions—assuming they are effective, safe for patients, and respect choice, innovation, and access,” Azar said in a statement. “Importation may well fit that bill in some instances.”
Sen. Lamar AlexanderLamar AlexanderMcConnell gets GOP wake-up call The Hill's Morning Report - Presented by Alibaba - Democrats return to disappointment on immigration Authorities link ex-Tennessee governor to killing of Jimmy Hoffa associate MORE (R-Tenn.), chairman of the Senate Health Committee, said he supports the FDA's efforts.
In a statement, Alexander said FDA "already approves the manufacture of prescription drugs in facilities overseas and it approves safe supply chains for those prescription drugs, so it makes sense to explore whether the FDA can do that in specific instances that increase competition and lower prices.”
But the Pharmaceutical Research and Manufacturers of America (PhRMA) said importing drugs, even in the very specific and narrow instances outlined by FDA, is not the answer.
“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," the industry group said.