On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence.” The Court ruled that FDA had erred in dismissing “specific” and “reasoned” expert testimony and scientific studies when denying a hearing on a Center for Drug Evaluation and Research (CDER) decision to not approve a supplemental NDA (sNDA).
Although the Court reaffirmed FDA's right to deny a hearing when “no material facts are genuinely disputed,” the decision is favorable to sponsors because it limits FDA's ability to issue perfunctory denials on the papers and could encourage FDA to resolve deficiencies identified in a complete response letter (CRL) earlier in the administrative process.
Recap of the background and opinion
In 2019, the sponsor of the product at issue submitted an sNDA for a new indication for one of its previously approved drug products. Under the Food, Drug, and Cosmetic Act (FDCA), FDA may approve an NDA, including an sNDA for a new indication, only if, among other things, the sponsor provides “substantial evidence” of effectiveness for the proposed use.
FDA issued a CRL refusing to approve the sNDA, concluding that the sponsor did not provide substantial evidence of effectiveness for the new indication. The sponsor first appealed the CRL through CDER's internal formal dispute resolution process. After years of back and forth with the agency, the sponsor then pursued the administrative hearing process set out in the FDCA, which provides the sponsor an opportunity for a hearing before the Commissioner. The hearing is an important procedural step and results in a final agency action that can be challenged in court. While a sponsor can pursue the formal dispute resolution process all the way to the Commissioner, the dispute resolution process does not result in final agency action.
After protracted agency interactions (including a successful action to compel the agency to “either finally resolve [the sponsor]'s application or commence a hearing”), FDA denied the sponsor's request for a hearing.
The sponsor petitioned the Court for review of FDA's final decision and hearing denial, arguing that it was entitled to a hearing under the statute by requesting one or, alternatively, because it had presented a material factual dispute. Under the regulations and by longstanding practice, FDA will deny or grant such a hearing based on a summary judgment standard. The Court ruled that FDA's decision to deny the sponsor a hearing was “arbitrary and capricious” because its expert testimony was “specific, reasoned, and rooted in evidence” and therefore sufficient to create a factual dispute, although in general, the Court said, a sponsor is not unequivocally entitled to hearing.
Implications for FDA's administrative process
To date, sponsors have not regularly requested administrative hearings on NDA denials, but the Court's decision could make doing so more attractive because FDA may be more reluctant to provide pro forma rejections on the papers. Public administrative hearing processes, including holding a hearing and justifying a hearing denial, are resource intensive for FDA. The Court's decision could make the agency more open to resolving deficiencies identified in a CRL to dissuade sponsors from requesting an administrative hearing.
The Court's opinion affirms that, although FDA can use summary judgment procedures to deny a hearing on an NDA (or sNDA) denial, its decision to do so based on a lack of “substantial evidence” must be sufficiently reasoned. Conclusory dismissals of an applicant's evidence or mischaracterizations of that evidence will not support a summary denial of a hearing. Courts will expect FDA to grapple with a sponsor's evidence in order to show that no material factual dispute exists.
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