Opinion: FDA calls states’ bluffs on drug importation
For decades, critics of the U.S. drug pricing system have advocated importing drugs from Canada as a convenient shortcut to lower prices. The Food and Drug Administration’s recent release of a proposed regulation to create a process for approving state-sponsored importation plans is one step closer to that goal. A closer look shows that it’s actually a false step.
Career FDA staff, supported by previous FDA commissioners and Health and Human Services secretaries, have long maintained that there is no way to open a drug import channel into the U.S. pharmaceutical supply chain without violating the 2003 law authorizing Canadian drug imports that required the FDA to certify that importation would create no safety risk to the public. Now, with a heavy twist of the arm from President Trump’s strong support for importation, the FDA has been forced to describe a possible pathway for it.
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