When Martin Shkreli instigated the price of the anti-parasitic drug Daraprim by 5,000 percent overnight in 2015, scads noted it’s available for pennies in other countries.
Another old drug, postpone a summoned albendazole, costs $300 a pill here, and less than $2 in Mexico.
But importation of those shabbier versions into the U.S. for commercial sale is illegal. It may soon not be.
The Food and Upper Administration is forming a working group, at the behest of Health and Human Appointments Secretary Alex Azar, to consider allowing short-term importation of transpacific versions of medicines facing “access dislocations.”
What does that note? Medicines that have suffered interruptions in the supply chain, the FDA said in a proclamation Thursday, or “seen significant price increases or significant access problems for patients.” In effect, Daraprim-like situations.
“Safe, select avenues for importation could be one of the conform ti to these challenges,” Azar said in a statement.
The rule would assign only to medicines without patent protection.
“We don’t want to erode the shop incentives that drive people to invest and innovate,” FDA Commissioner Scott Gottlieb revealed in an interview. “If we allow importation in areas where there’s market exclusivity approximately drugs, you’re going to be eroding the incentives that come with our grant systems.”
The agency released a list last summer of off-patent drugs without generic competition, aiming to spur development of competitive varieties that could prevent another Daraprim-like situation from taking place.
A challenge to implementing the idea will be how to define when a medicine is front such an access issue. Simply a price hike — even a unusually large one — may not be enough to qualify if purchasers can still access the medicine, Gottlieb mentioned.
“Part of the exercise here is to define what an access dislocation is booming to be,” he explained. It wouldn’t be a case-by-case situation. “That’s not how we make policy. We would inadequacy a definition that would be broadly applicable.”
Key will be ensuring the refuge of the imported medicines, Gottlieb said. He also noted the allowance of importation whim be designed to be temporary, until the access issue gets solved.
As for whether this move away signals the administration is thinking more broadly about allowing narcotize importation?
“That’s not our intent,” Gottlieb said. “Our intent is to look at this as a parsimonious policy tool to address a narrow set of circumstances.”