Show Us The Birth Certificate? An Authorless US FDA Import Policy
For two decades it has been almost dogma in the US pharmaceutical industry that no FDA commissioner would sign off on a policy to permit wholesale imports of drugs from Canada. Now that a proposed rule has been issued – it still may be true.
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The very public attempt by the state of Florida to question FDA’s decision on COVID monoclonal antibodies is the latest example of how the politics of COVID is roiling the agency’s reputation. But is it really so different than Florida’s pre-pandemic plans to import drugs from Canada?
Steven Grossman argues that the former commissioner possessed the credentials to be out front on the pricing issue, unlike other recent FDA commissioners and the current holder of the office.
Proposed rule allowing states to import certain drugs from Canada would require tight supply chain, extensive security and reporting responsibilities. The potential costs and rigor involved in implementing the program could impede its uptake.