Why the FDA Suddenly Hit Pause on Drug Rejection Letters
The FDA has stopped publishing new Complete Response Letters while it reviews its transparency policy. A spokesperson for the U.S. Department of Health and Human Services confirmed that the pause began in April. The agency is now evaluating the publication process and considering its next steps.
The decision follows a citizen petition filed by an unnamed pharmaceutical company. The company argued that publicly released CRLs could expose confidential commercial information. As a result, the FDA decided to suspend the program while reviewing the concerns.
A Transparency Push That Quickly Faced Industry Resistance
The latest Complete Response Letter available in the FDA database relates to AbbVie’s investigational botulinum toxin, trenibotulinumtoxinE. The agency published that letter on April 22.
However, more recent regulatory decisions have not appeared in the database. One example is the FDA’s late-June rejection of Sobi’s investigational gout therapy. This change clearly shows when the publication pause took effect.
The Confidentiality Dispute Behind the FDA's Decision
The CRL publication program formed part of a broader transparency initiative introduced by Health Secretary Robert F. Kennedy Jr. and former FDA Commissioner Marty Makary. Last September, the FDA released 89 additional Complete Response Letters. Earlier, the agency had already published another 200 historical CRLs.
Those documents included several high-profile regulatory decisions. They covered products from Ultragenyx, Capricor Therapeutics and Replimune. Consequently, many Regulatory Affairs and Quality professionals began using published CRLs to better understand FDA expectations and common review deficiencies.
Why Complete Response Letters Matter Beyond Drug Approvals
The citizen petition, submitted through law firm Covington & Burling, asked the FDA to strengthen its review process before publishing CRLs. The company also requested greater involvement during the disclosure process.
According to the petition, several published letters allegedly contained information that should have remained confidential. The filing specifically referenced documents involving Lykos Therapeutics and Stealth BioTherapeutics. Capricor Therapeutics also stated that the FDA did not notify the company before publishing its CRL. The company further disputed the agency’s interpretation of its clinical efficacy data.
The Future of FDA Transparency Now Depends on One Key Decision
Although the FDA has paused the program, the agency has not abandoned its transparency goals. Instead, it has proposed a new rule that would expand the Commissioner’s authority to release Complete Response Letters. The proposal would also remove the long-standing assumption that the existence of a marketing application automatically qualifies as confidential commercial information.
Earlier this year, former FDA Commissioner Marty Makary also asked Congress to amend the Federal Food, Drug, and Cosmetic Act. The proposed amendment would explicitly authorize the FDA to disclose information contained in CRLs. While Makary has since left the agency, the FDA continues to evaluate how future disclosure can balance transparency with the protection of proprietary information.
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Source: Fiercebiotech.Com