More of a Bad Thing? Thoughts on FDA’s Proposal to Extend the FDR Process to Withdrawals of Accelerated Approvals

April 13, 2022By Michelle L. Butler & Josephine M. Torrente

On March 28, 2022, FDA transmitted its justification to Congress for its Fiscal Year 2023 budget.  This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act.  The proposal to “revise 506(c)(3) so that FDA can follow its dispute resolution [(FDR)] procedures for drug applications when withdrawing a drug product’s accelerated approval” caught our attention in light of our extensive experience with the FDR process.

Consistent with due process considerations, the administrative hearing process that is currently used for the withdrawal of a drug approved via accelerated approval requires the Agency to provide the administrative record to the applicant.  In contrast, FDA’s custom in an FDR is not to disclose the administrative record or even a review division’s underlying reviews to the applicant.  As previously noted, this lack of transparency significantly hampers an applicant’s ability to present a winning case.  Certainly FDA’s application of this unwarranted lack of transparency shouldn’t be extended to now also affect the withdrawal procedures for an accelerated approval.

We would instead hope to see the Agency begin to provide the administrative record and/or the medical/statistical reviews (depending on the context) for all FDRs, such as those appealing complete response actions (CRs).  The importance to sponsors and applicants of obtaining the division’s reviews of their applications is underscored by the recent lawsuit filed by Vanda Pharmaceuticals, Inc. (Vanda) to obtain the medical and scientific reviews underlying a CR letter it received for a supplement to an approved NDA.  See Vanda Pharmaceuticals, Inc. v. Food and Drug Administration, No. 1:22-cv-0938 (D.D.C. Apr. 6, 2022).  As Vanda noted in its complaint, without those underlying reviews, it cannot know the detailed basis for FDA’s decision not to approve its supplement and whether FDA’s decision was the result of a factual error or whether or how Vanda should adapt its development program.

A key to efficient drug development is transparency.  When FDA decides to take an action – be it to withdraw a drug approved via accelerated approval or to issue a CR letter – disclosure to the affected party of the detailed reasons for the decision is crucial.  If Congress were to give FDA the authority to follow its FDR procedures for the withdrawal of an accelerated approval, it is imperative that the FDR procedures specifically require that FDA provide the administrative record to the applicant.  Otherwise, the applicant will be deprived of the process it is due, the FDA deciding official will not have the benefit of a fulsome debate, and patients with serious conditions may unnecessarily lose access to a safe and effective drug when no other therapy is available.