WASHINGTON — The Trump administration is opening up the door to importing prescription drugs — at least in a limited number of cases.
The administration said Thursday that the Department of Health and Human Services will form a working group to look at the idea of importing drugs from other countries in cases in which there is a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.
And although the announcement was cast as an early step, health secretary Alex Azar left little doubt the administration planned to eventually approve a significant policy change.
“I told the FDA commissioner, I said, ‘I insist that you find a pathway to make this happen,'” he said in an interview on the Fox Business Network. “I believe we can do it in a way that is safe, effective, leading to results, and that preserves innovation. So make it happen and make it happen quickly.”
The proposal is one of the boldest the administration has yet floated as it has laid out a series of ways to bring down the cost of prescription drugs. Although President Trump said on the campaign trail that he supports importing drugs from other countries as a way to lower prices for Americans, the notion has traditionally been more popular among Democrats. Independent Sen. Bernie Sanders of Vermont, the former presidential candidate, is one of its most vocal proponents.
Most Republican policymakers, however — including Azar himself — have long been opposed to the idea on the grounds that it could jeopardize patient safety.
But Azar said Thursday there are situations where importation could make sense. He pointed to Turing Pharmaceuticals’ 2015 decision to raise the price of the drug Daraprim by more than 5,000 percent, the dramatic spike that made then-CEO Martin Shkreli a household name.
“Safe, select avenues for importation could be one of the answers to these challenges. 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.
The administration emphasized in its announcement that the proposal will not apply to a broader category of drugs, the way some legislative proposals have. Broad importation would “raise additional questions about how to protect American patients,” HHS said.
In his own statement, the commissioner of the Food and Drug Administration, Scott Gottlieb, emphasized just how “narrow” the conditions for such importation might be.
“Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories,” he said. “Furthermore, any resulting policy would also be narrowly tailored in order not to create the same risks of counterfeits or other unsafe drugs getting into the U.S. supply chain as a broader importation policy would present.”
He added that the administration’s ultimate goal is to have multiple FDA-approved versions of each medically important drug, and that the working group will search for a policy that “facilitates near term access, while safeguarding the incentives that support a safe, stable and high-quality drug supply over the long term.”
Both brand and generic drug makers were quick to criticize the idea. The trade group PhRMA called it a “scheme” that would “circumvent the robust safety requirements we have in United States, posing a serious public health risk and jeopardizing our secure medicine system.”
BIO also lambasted the proposal, saying it was a “dangerous approach that would undermine the integrity and safety of the American drug supply.”
“It also offers illusory savings, as the government itself has repeatedly acknowledged,” the group’s president and CEO, Jim Greenwood, said in a statement. “We will work to ensure that any HHS actions on importation do not endanger patients or import foreign price controls on American innovation.”
The Association for Accessible Medicines, which lobbies for generic manufacturers, said the policy idea “will not solve the underlying under-reimbursement issues” for generic drugs.