Thoughts on FDA's proposal to extend the FDR process to withdrawals of accelerated approvals

The US Food and Drug Administration recently 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, commented law firm Hyman, Phelps & McNamara’s Michelle Butler and Josephine Torrente.

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, the 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 the FDA’s application of this unwarranted lack of transparency shouldn’t be extended to now also affect the withdrawal procedures for an accelerated approval.