FDA Resumes Controversial Complete Response Letter Transparency Policy After Three-Month Pause
The U.S. Food and Drug Administration (FDA) has resumed its controversial policy of publishing unapproved drug rejection letters, known as Complete Response Letters (CRLs), in real-time. On July 10, 2026, the agency dropped a new batch of 14 CRLs, and on July 14, 2026, the Department of Health and Human Services (HHS) confirmed that the three-month suspension of the transparency initiative has officially been lifted.
Background and the April 2026 Suspension
The CRL disclosure policy was a hallmark of the "radical transparency" push championed by former FDA Commissioner Marty Makary, M.D., and Health Secretary Robert F. Kennedy, Jr. Historically, CRLs were treated as confidential commercial information, leaving the public and investors dependent on drug sponsors' selective disclosures. Under the new initiative, which launched in late 2024 and expanded in September 2025 with an initial batch of 89 letters, the FDA began proactively publishing redacted CRLs.
However, the policy sparked fierce industry pushback. In April 2026, the FDA "temporarily paused" the practice after a prominent law firm, Covington & Burling, filed a citizen's petition on behalf of an undisclosed pharmaceutical company. The petition argued that the real-time publication of CRLs violated federal statutes protecting trade secrets and confidential commercial information, creating a risk of severe "competitive harm" for drugmakers. The attorneys called for a formal mechanism allowing manufacturers to review and provide input on redactions before any public posting.
Resumption and the July 2026 Tranche
The three-month freeze ended on July 10, 2026, when the FDA posted a tranche of 14 CRLs dating back to April 23, 2026. This newly released batch includes:
- Grace Therapeutics' rejection for its injectable nimodipine formulation (April 23, 2026).
- The third FDA rejection for Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics' combination of camrelizumab and rivoceranib in liver cancer (July 10, 2026).
An HHS spokesperson confirmed on July 14, 2026, that the FDA has used the pause to "strengthen and formalize its internal processes for reviewing, redacting and publishing CRLs" in order to protect trade secrets while continuing its commitment to public transparency.
Formalizing the Policy
To cement this practice, the FDA has proposed a formal rule (RIN 0910-AJ16) that would eliminate the longstanding presumption that a marketing application's mere existence or rejection constitutes confidential commercial information. If finalized, this rule would permanently grant the FDA commissioner the authority to release CRLs without being vulnerable to industry lawsuits.