FDA: Pharmacists and wholesalers can import drugs from Canada
Pharmacists and drug wholesalers can import prescription medicines from Canada for up to two years as part of state programs aimed at bringing down drug costs, according to final FDA guidance released Thursday.
Why it matters: With President Biden's drug pricing agenda still stalled, the FDA is further clarifying how states could take advantage of lower drug costs abroad without the need to limit prices in the U.S.
Background: Both the Biden and Trump administrations embraced limited importation to bring down health costs, though experts view the policy as having limited impact.
- The FDA in April began discussions with five states — Florida, Colorado, Vermont, Maine and New Mexico.
How it works: The guidance lays out requirements for importing drugs from wholesalers licensed by Canadian regulators and for testing and labeling the drugs. It excludes some controlled substances, biological products and infused drugs.
Yes, but: The administration has sent decidedly mixed signals on importation, supporting the idea in theory while arguing in legal briefs it won't work.
- Canada has said its market is too small to make a dent on U.S. drug prices, and many drug suppliers there have said they won't participate.