FDA considers drug imports to cut costs
WASHINGTON — The Trump administration is cracking open the door to using prescription drugs imported from overseas — ones that have not been approved by the Food and Drug Administration — to combat high drug prices in limited circumstances.
The FDA said Thursday that it plans to create a working group to examine how to safely import drugs in a specific situation: when there’s a sharp price increase for an off-patent drug produced by a single manufacturer.
In those cases, imports “could help address price hikes and supply disruptions that are harming American patients,” Health and Human Services Secretary Alex Azar said in a statement. As an example, he cited the 2015 case of Daraprim, an old drug whose price was hiked from $13.50 to $750 a pill by Martin Shkreli.
Rachel Sachs, a professor at the Washington University School of Law, called the idea “a very smart move that would allow the administration to respond to some of the worst actors that we have seen in drug pricing.” But she added that such a strategy wouldn’t work against the kind of year-over-year price increases that have pushed up the costs of branded drugs — nor is the administration proposing that any importation be used that way.
Generally, the importation of drugs from other countries 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 to ease supply shortages, such as those resulting from last year’s hurricane in Puerto Rico.
FDA commissioner Scott Gottlieb stressed in a statement that the “access disruptions” caused by sudden price hikes were similar to those caused by severe shortages. The working group, he said, would examine whether the added competition provided by imports would help patients afford medications until new competition emerged.
The Pharmaceutical Research and Manufacturers of America, the industry’s main trade group, immediately slammed the idea, saying even limited importation would “circumvent the robust safety requirements we have in United States, posing a serious public health risk and jeopardizing our secure medicine system.”
The Association for Accessible Medicines, which lobbies for generic drugmakers, said that importation “will not solve the underlying under-reimbursement” of generic drugs.
Meanwhile, President Donald Trump on Thursday praised Novartis for becoming the second pharmaceutical company, along with Pfizer, in as many weeks to pull back planned price increases in the United States amid public pressure from the president.