FDA mulls drug importation with states
The FDA has started discussions with states over creating a way to import drugs from Canada — a policy the Biden and Trump administrations both embraced to bring down health costs but which experts regard as having limited impact.
The big picture: With President Biden's drug pricing agenda stalled, importation could allow states to take advantage of lower drug prices abroad without the need for direct action to limit prices in the U.S.
- Under one pathway, states, wholesalers and pharmacies submit importation proposals to HHS, which would be subject to safety and cost conditions.
Driving the news: The FDA last week held its first meeting with five states — Florida, Colorado, Vermont, Maine and New Mexico — that have submitted reimportation plans or are thinking about doing so, Politico first reported.
- Biden's executive order on promoting competition directed the FDA to work with states and Native American tribes on safely importing prescription drugs from Canada.
- "The FDA is committed to working with states and Indian tribes that propose to develop ... importation programs to reduce the cost of products to the American consumer while still protecting public health and safety," an agency spokesman told Axios.
Yes, but: The Pharmaceutical Research and Manufacturers of America sued to block a 2020 federal rule that would facilitate importation, citing patient safety and other concerns.
- Canada also said it has no plans to participate and has told drugmakers not to take steps that could lead to drug shortages there.
Cowen analyst Rick Weissenstein notes the Biden administration has been inconsistent on reimportation, supporting the idea in theory while arguing that it won't work in legal briefs filed in response to the drug industry trade group's legal challenge.
Our thought bubble: With Canadians officials adamant they won't participate in the process, any importation plan is unlikely to actually bring down drug prices. The issue still could be politically appealing as the campaign season heats up.