As part of the Trump administration's ongoing efforts to address drug prices, the Food and Drug Administration will convene a working group to investigate importing certain medications to increase competition.
The working group will examine how importation could introduce competitors to drugs that are off-patent but have a single manufacturer, FDA Commissioner Scott Gottlieb, M.D., said in a statement.
The group will consider a number of policy frameworks that would take advantage of importation while ensuring the imported drugs are safe for patients to use, Gottlieb said.
"We want to examine whether—under these narrow conditions—the additional market competition from the short-term importation of foreign versions of the drug may complement the FDA's current efforts and help meet near-term patient need in the U.S. until competition is able to enter the domestic market," Gottlieb said.
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Chad Landmon, chair of law firm Axinn, Veltrop & Harkrider LLP's FDA and intellectual property practice groups, told FierceHealthcare that even convening the working group is a significant step for the agency.
If FDA does move forward with importation for the narrow scope of situations the working group is focusing on, it opens the door for importation to be implemented more broadly, Landmon said.
"Just allowing importation, even in limited circumstances, you could see it then being broadened as time went on," he said.
Importation, even in a limited way, is not likely to go unchallenged, though, if the FDA decides to try it, Landmon said. Legal challenges from pharmaceutical companies are likely, especially if importation moves forward in the administration without Congress weighing in to approve it, he said.
A potential wrinkle in the legal debate could be the future makeup of the Supreme Court, Landmon said. Should a justice nominated by President Donald Trump be confirmed to replace the retiring Anthony Kennedy—as is widely expected—a conservative-leaning court could be inclined to strike down an action that's done through federal agency enforcement and not legislation.
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The FDA is pursuing further information on importation as part of the administration's overarching plan to reduce drug costs. The blueprint, titled "American Patients First," focuses on market-based solutions to lower prices, and the FDA has taken a number of steps so far to boost generic competition.
The formation of the working group comes on the heels of an "action plan" to improve access to biosimilars and biologics.
Department of Health and Human Services Secretary Alex Azar said in a statement that "safe, select avenues for importation" offer another tool to lower prices.
"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. "Importation may well fit that bill in some instances."