FDA Resumes Controversial Complete Response Letter Transparency Policy After Three-Month Pause
The U.S. Food and Drug Administration (FDA) has officially confirmed that it did not freeze or permanently suspend its policy of publishing unapproved drug rejection letters, known as Complete Response Letters (CRLs). Following reports of a temporary pause in publication due to a legal challenge, the agency affirmed its commitment to the "radical transparency" campaign championed under Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr.
On July 23, 2026, HHS Press Secretary Emily Hilliard clarified the administration's stance:
"Under Secretary Kennedy’s leadership, FDA remains committed to increasing transparency through the proactive release of Complete Response Letters (CRLs). Transparency and public confidence are central to FDA’s mission to protect public health, and the American people deserve clear, timely, and accurate information about the agency’s regulatory decisions."
Indeed, the FDA resumed its proactive release on July 10, 2026, uploading a new batch of 14 heavily redacted CRLs to its public portal. This latest batch demonstrates the tension between the agency's drive for disclosure and pharmaceutical companies' proprietary interests.
Highlights of the July 10 CRL Batch
The latest batch of uploaded rejection letters mostly focus on product quality and facility deficiencies, though several highlight critical clinical and trial design disputes:
- Ascelia Pharma's Orviglance (oral MRI contrast agent): The FDA's CRL revealed that the rejection stemmed from concerns over how clinical trial image readers were trained. After an initial set of readers failed to find superior efficacy, Ascelia conducted a re-evaluation with a new process and three new readers. The FDA noted that the re-evaluation "may have introduced bias in the training of the new readers due to knowledge of the images and initial read results." While Ascelia maintains the new readers were fully independent and blinded, the public posting of the CRL forced the company to issue a detailed public update to address the specific FDA criticisms.
- Galderma's RelabotulinumtoxinA (Botox competitor): The published CRL indicated that the FDA "conveyed deficiencies" regarding the manufacturing facility following a pre-license inspection, specifically citing analytical method optimization.
Legal and Administrative Background
The transparency initiative, which originally launched in July 2025 with a dump of over 200 past CRLs, ran into legal uncertainty in April 2026 when an unnamed pharmaceutical company filed a formal citizen petition (Docket No. FDA-2026-P-4369-0001) challenging the legality of the practice. The petitioner argued that publishing CRLs "contravenes decades of agency practice with no adequate explanation" and requested that the FDA give manufacturers 10 days to contest redactions before any letter goes public.
The FDA is required to respond to the citizen petition within 180 days of receipt, establishing a formal deadline of October 17, 2026 (see fda-response-to-crl-public-disclosure-citizen-petition-docket-fda-2026-p-4369). Concurrently, the FDA is moving forward with a proposed rule (RIN 0910-AJ16) to eliminate the longstanding presumption of commercial confidentiality for unapproved marketing applications (see fda-final-rule-on-complete-response-letter-public-disclosure-rin-0910-aj16).