Whether FDA has acted contrary to its statutory mandate by substituting an evaluation of a drug development program's potential for assessing a new drug's inherent potential to address unmet medical needs

Congress enacted the Fast Track program to speed the development and approval of certain novel therapies. It required FDA to designate “ a new drug ” as a “fast track product” if “it is intended * * * for the treatment of a serious or life -threatening disease or condition, and it demonstrates the potential to ad-dress unmet medical needs for such a disease or con-dition.” 21 U.S.C. § 356(b)(1). The question s presented are: 1. Whether FDA has acted contrary to the statutory mandate by substituting an evaluation of the potential of a sponsor’s current drug development pro-gram for an assessment of “a new drug [’s]” own inherent “potential to address unmet medical needs .” 2. Whether an approach to statutory interpretation that upholds an agency construction so long as it is “reasonable” and “consistent with” the statute’s “goal ” (App., infra , 17a) unlawfully departs from the Court’s instructions in Loper Bright Enter prises v. Raimondo , 603 U.S. 369, 400-4 01 (2024).