FDA says former officials' journal articles do not represent agency policy after lawmaker criticism

Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulatory interpretation.

DeGette had earlier questioned the FDA’s adherence to its own guideline‑release practices, accusing former commissioner Marty Makary of a "shoot-from-the-hip" approach that left drugmakers and researchers uncertain about official rules.

The FDA letter noted that articles, press releases and podcasts by Makary and former CBER director Vinay Prasad bypassed the agency’s normal policymaking process, a point that has raised concern within the industry.

The clarification reaffirms that only formal FDA communications constitute official policy, reinforcing the agency’s procedural standards.