Trump administration to explore drug imports

Working group to look at foreign sources as a way of fighting high prices

WASHINGTON — The Trump administration is cracking open the door to using drugs imported from overseas to combat high drug prices in limited circumstances.

Health and Human Services Secretary Alex Azar last week directed the Food and Drug Administration to create a working group to examine how to safely import prescription drugs from other countries in the event of dramatic price increases for a drug produced by one manufacturer and not protected by patents. Such imports “could help address price hikes and supply disruptions that are harming American patients,” Azar said in a statement.

Azar singled out the 2015 case of the drug Daraprim, whose price was famously hiked 5,000 percent by Martin Shkreli.

“Safe, select avenues for importation could be one of the answers to these challenges,” Azar said. In such situations, administration officials said, an imported alternative could provide a new avenue for competition to drive down prices. Importation would be limited to cases where drugs can be imported with adequate assurances of safety and effectiveness.

The importation move is the administration’s latest foray into the heated debate over drug pricing. Last week, Novartis said it decided not to raise prices on its medicines in the United States for the rest of the year. And Pfizer recently agreed to defer substantial price increases on more than 40 medicines after its chief executive spoke with President Donald Trump.

Generally, the importation of drugs from overseas is illegal. But the FDA doesn’t enforce the ban against individuals bringing in small amounts of drugs for personal use. And it occasionally allows the importation of foreign-approved drugs into the U.S. by manufacturers and suppliers to ease a supply shortage.

The FDA, Commissioner Scott Gottlieb said in a statement, could take a similar path for drugs whose prices rise sharply. Price hikes, he said, “can create public health consequences that are similar to the occurrence of a drug shortage.” Any importation of foreign-approved drugs would be rare and temporary, until adequate competition emerged in the United States, he added.

Still, any move toward importation could scare big pharmaceutical companies, whose soaring drug prices have sparked disapproval from the White House.

Importation is opposed by the pharmaceutical industry and most Republicans. During the presidential campaign, Trump expressed support for the idea, but it wasn’t included in the administration’s recent proposal to bring down drug prices. Many Democrats are strong supporters of importation.

A 2003 law allows importation of drugs from Canada if the Department of Health and Human Services certifies such a move would not increase safety risks for patients and would generate cost savings for U.S. consumers. So far, no HHS secretary has signed off on those conditions.

The four most recent FDA commissioners have warned that legalizing drug imports could endanger consumers by exposing them to potentially fake, substandard and contaminated drugs. But critics of high prices respond that such safety concerns are overblown, and that there are ways to ensure consumers can buy safe drugs.