FDA says it has not paused CRL releases amid transparency push

An unnamed pharmaceutical company filed a citizen petition in April asking the FDA to change how it publicly releases Complete Response Letters, arguing the new policy conflicts with long‑standing agency practice.

The FDA responded to media reports of a freeze on CRL publication, confirming that no such pause exists. HHS Press Secretary Emily Hilliard emphasized the agency’s commitment to transparency and public confidence.

Data from the FDA portal show that 14 new CRLs were posted after the alleged freeze, and the agency indicated it will continue to publish appropriately redacted letters, building on a batch released on July 10.

The episode highlights ongoing legal and procedural uncertainty around the FDA’s “radical transparency” initiative for rejection letters.