FDA for the first time approves plan to import drugs
The Food and Drug Administration on Friday approved a plan allowing Florida to import cheaper prescription drugs from Canada, opening the door for states to buy direct from pharmacies there to stock their state-run health programs.
Why it matters: The approval, the first of its kind, allows the Biden administration to show it's addressing a major voter concern in an election year but is likely to draw legal challenges from the pharmaceutical industry.
- Canadian officials have signaled they have no plans to participate in the process — and have already taken steps to prevent some medicines that are in short supply from being drained.
Go deeper: At least eight other states are seeking FDA approval to import some drugs or plan to.
- Any state receiving approval would have to take responsibility for ensuring imported medicines are safe and for relabeling products so they're consistent with FDA standards.
The FDA's greenlight ends a tussle between the agency and Florida Gov. Ron DeSantis' administration, which first applied for importation in late 2020 under the Trump administration and had sued the Biden administration, charging it was slow-walking the approval.
- "The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals," FDA Commissioner Robert Califf said in a statement on Friday.
- "These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs."
- Florida initially aims to import drugs treating AIDS, hepatitis C and mental illness, among other conditions. The state has estimated it will save as much as $150 million per year through the program.
The big drug industry trade group PhRMA said on Friday that it was considering all options for preventing the plan from taking effect.
- "We are deeply concerned with the FDA's reckless decision to approve Florida's state importation plan," said the group's President and CEO Stephen Ubl.
- "Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health."
The big picture: Importation has long been seen as a political winner, allowing states to take advantage of lower drug prices abroad without the need for direct action to limit prices in the U.S.
- But the Biden administration has staked out contradictory stances. It's supporting the idea in theory while arguing that it won't work in legal briefs filed in response to one drug industry trade group's legal challenge.
- Experts have said a more direct way to lower drug costs is having the government directly negotiate prices with manufacturers. The Inflation Reduction Act authorized Medicare to begin talks on a limited number of high-priced medicines, with the first negotiated prices set to be announced later this year.
What they're saying: "I think it's going to be hard for states to import drugs like that in any kind of scale that would make a difference in terms of lowering prices for patients," Harvard Medical School professor Aaron Kesselheim told the New York Times.
- "There is a yawning gap between the public enthusiasm for Canadian drug imports and the consensus view from experts that it's a daft approach," University of Michigan law professor Nicholas Bagley wrote on X.