FDA calls states’ bluffs on drug importation


Manatt Health senior advisor Ian Spatz wrote an article for STAT on the Food and Drug Administration’s recently proposed regulation to create a process for approving state-sponsored importation plans for pharmaceuticals from Canada as a convenient shortcut to lower prices. In this article, Spatz details how this proposed regulation is a false step, saying, “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.”

Read the article here



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