Trump administration may open door to imported drugs in limited cases — including after some price hikes

  • The Food and Drug Administration is forming a working group to consider allowing short-term importation of foreign versions of medicines facing “access dislocations.”
  • The rule would apply only to medicines without patent protection.
  • This could include medicines suffering from an interruption in the supply chain.
United States Secretary of Health and Human Services, Alex Azar.
Sebastián Vivallo Oñate | Agencia Makro | Getty Images
United States Secretary of Health and Human Services, Alex Azar.

When Martin Shkreli raised the price of the anti-parasitic drug Daraprim by 5,000 percent overnight in 2015, many noted it’s available for pennies in other countries.

Another old drug, called albendazole, costs $300 a pill here, and less than $2 in Mexico.

But importation of those cheaper versions into the U.S. for commercial sale is illegal. It may soon not be.

The Food and Drug Administration is forming a working group, at the behest of Health and Human Services Secretary Alex Azar, to consider allowing short-term importation of foreign versions of medicines facing “access dislocations.”

What does that mean? Medicines that have suffered interruptions in the supply chain, the FDA said in a statement Thursday, or “seen significant price increases or significant access challenges for patients.” In effect, Daraprim-like situations.

“Safe, select avenues for importation could be one of the answers to these challenges,” Azar said in a statement.

The rule would apply only to medicines without patent protection.

"We don't want to erode the market incentives that drive people to invest and innovate," FDA Commissioner Scott Gottlieb said in an interview. "If we allow importation in areas where there's market exclusivity around drugs, you're going to be eroding the incentives that come with our patent systems."

The agency released a list last summer of off-patent medicines without generic competition, aiming to spur development of competitive versions that could prevent another Daraprim-like situation from happening.

A challenge to implementing the idea will be how to define when a medicine is facing such an access issue. Simply a price hike — even a very large one — may not be enough to qualify if purchasers can still access the medicine, Gottlieb said.

"Part of the exercise here is to define what an access dislocation is going to be," he explained. It wouldn't be a case-by-case situation. "That's not how we make policy. We would want a definition that would be broadly applicable."

Key will be ensuring the safety of the imported medicines, Gottlieb said. He also noted the allowance of importation would be designed to be temporary, until the access issue gets solved.

As for whether this move signals the administration is thinking more broadly about allowing drug importation?

"That's not our intent," Gottlieb said. "Our intent is to look at this as a narrow policy tool to address a narrow set of circumstances."