FDA/HHS Withdraw Trump Policy on Drug Stats

FDA and HHS are withdrawing a policy statement on drug review transparency that was issued in the final days of the previous administration. The 1/15 policy required FDA to publish annually for each NDA/ANDA approved the total days that elapsed between initial submission and approval. It is now being revoked because it did not account for all information that is already publicly available on FDA’s review of drug applications.

The policy reportedly came as a surprise to FDA at the time, indicating a frayed relationship between then-commissioner Stephen Hahn and then-HHS secretary Alex Azar and other administration officials (see earlier story). The announcement rattled former FDA commissioner Scott Gottlieb, who said on Twitter: “I've been disappointed to see HHS infringing on FDA’s public health prerogatives in the closing days of the administration. The way they’re pursuing these unilateral actions will have long-term consequences at a time when FDA’s stature is critical to seeing us through this [Covid-19] crisis.”