In a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for Information Regarding Drugs Potentially Generally Recognized as Safe and Effective” (here).

The notice indicates that the FDA was never consulted by HHS when HHS took the action withdrawing the UDI, which appeared in the FR under the HHS and not the FDA filings, in what is, in my opinion, the most aggressive attack by the FDA on its parent organizational unit that I have ever seen in a Federal document.

Today’s notice appears to be the beginning of the rebirth of the UDI from the FDA’s perspective, although the Agency claims that the fundamental enforcement activities regarding unapproved marketed prescription drugs has never changed, even during the period of withdrawal of the UDI by HHS.  The FDA further indicates that new guidance issued under good guidance practices “will provide appropriate updates regarding FDA’s enforcement priorities for marketed unapproved new drugs.  In the interim, before such guidance is issued, FDA will continue to exercise its existing general approach to prioritizing regulatory and enforcement action, which involves risk-based prioritization in light of all the facts of a given circumstance.  Risk-based enforcement best supports FDA’s public health priorities.”

The notice provides detailed description of the inaccuracies in the original November 25, 2020 request for comment on the withdrawal of the UDI.  Hold onto your hats – the FDA is back in charge of drugs, folks!  Welcome back, FDA, and thanks for bringing back the law and further supporting the safety and efficacy of the nation’s drug supply!