FDA Plans Proposed Rule to Formally Codify Complete Response Letter Public Disclosure Policy
The U.S. Food and Drug Administration (FDA) is moving to permanently codify its controversial policy of proactively publishing Complete Response Letters (CRLs)—the formal rejection letters issued to pharmaceutical sponsors when a drug or biologic application is not approved.
Proposed Rule (RIN 0910-AJ16) on the 2026 Unified Agenda
The White House Office of Management and Budget (OMB) recently released the administration's 2026 Unified Agenda of planned regulatory actions, which includes a proposed rule under RIN 0910-AJ16 titled "Proposed Rule to authorize FDA to proactively release complete response letters (CRLs) issued to therapeutic product applications."
This rulemaking represents a major administrative effort to establish a permanent regulatory basis for the transparency policy. The FDA began proactively disclosing CRLs on its openFDA platform in 2025 as part of a "radical transparency" push. However, the agency did so without an explicit statutory or regulatory mandate, relying instead on administrative discretion. By initiating formal rulemaking, the FDA seeks to eliminate the long-standing presumption of commercial confidentiality for unapproved marketing applications.
Ongoing Legal and Administrative Backlash
The transparency push has faced intense resistance from the biopharmaceutical industry, which argues that CRLs contain proprietary manufacturing details, trade secrets, and sensitive clinical discussion that should remain confidential.
The policy's legal vulnerability is highlighted by a high-profile citizen petition (Docket No. FDA-2026-P-4369-0001) filed by Covington & Burling LLP on behalf of an unnamed pharmaceutical company. The petition argues that the proactive disclosure of CRLs violates federal laws governing trade secrets and commercial confidentiality, and requests that the FDA establish a clear process to protect proprietary data.
Broader Rulemaking in the Pipeline
The CRL transparency rule is part of a broader slate of significant rulemakings scheduled for late 2026, including:
- RIN 0910-AJ14 (December 2026): A proposed rule to eliminate the "adequate provision rule" (21 C.F.R. § 202.1(e)), which currently allows broadcast advertisements (TV/radio) to fulfill the statutory brief summary requirement by directing consumers to external sources for detailed safety/risk information. Revoking this rule is expected to be "economically significant," forcing companies to buy longer ad slots or pull broadcast ads.
- RIN 0910-AH61 (October 2026): Good manufacturing practice (GMP) requirements for outsourcing compounding facilities.
- RIN 0910-AI87 (December 2026): Registration and "good importing practice" requirements for commercial drug importers.