The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has learned, following a citizen’s petition from an unnamed pharma company in April.
The agency announced a plan last September to publish complete response letters (CRLs) in real-time when making decisions to approve or reject drug applications. But after a petition challenged the policy for its potential to publicize proprietary information, the FDA “temporarily paused” the effort starting in April, a Department of Health and Human Services spokesperson told Fierce.
“The agency is evaluating the process and potential next steps,” the spokesperson added.
The most recent rejection added to the FDA’s database is the April 22 spurning of AbbVie’s investigational botulin toxin trenibotulinumtoxinE. More recent rejections, like the late June denial of a gout prospect from Sobi, have not had CRLs published.
The CRL policy was part of a “radical transparency” push championed by Health Secretary Robert F. Kennedy, Jr., and former FDA Commissioner Marty Makary, M.D. The September announcement was accompanied by a tranche of 89 letters that followed an earlier drop of 200 CRLs last July.
That fresh batch of 89 letters included recent high-profile rejections like Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug RP1 (vusolimogene oderparepvec).
In challenging the policy, law firm Covington & Burling wrote on behalf of the undisclosed pharma company that the agency needed to involve companies more in the disclosure process and be sure to fully redact all confidential information. The petition listed several specific incidences of unredacted material information in published CRLs, including rejections for Lykos Therapeutics, Stealth BioTherapeutics and others.
When its CRL was published, Capricor released a statement of its own saying it had not been notified in advance by the FDA, further accusing the agency of misinterpreting its efficacy data.
Though the policy has been paused for now, the FDA has launched efforts to codify it. The regulator has proposed a rule that would expand the commissioner’s ability to release CRLs and “eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information.”
In April, former FDA leader Makary also asked Congress to amend the Federal Food, Drug, and Cosmetic Act to explicitly allow the agency to release information contained in CRLs, part of a suite of asks Makary made to lawmakers. Makary departed the FDA in May and has been replaced on an acting basis by Kyle Diamantas.