Brief for Food and Drug Law Scholars and Professors as Amici Curiae Supporting Petitioners and Reversal

Authors

Rebecca S. Eisenberg, University of Michigan Law SchoolFollow

Document Type

Brief

Publication Date

1-30-2024

Abstract

Amici curiae are U.S. food and drug law scholars and professors from academic institutions across the United States. A full list of amici is included as an Appendix to this brief. Amici have expertise in food and drug law, including the drug approval process and regulation of pharmaceuticals under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. Amici submit this brief to address important issues raised by this case concerning the authority of the U.S. Food & Drug Administration (FDA or the Agency) to regulate prescription drugs.

The Federal Food, Drug, and Cosmetic Act sets out a comprehensive process under which FDA reviews and approves new drugs, and major changes to approved applications, before such products may be introduced into interstate commerce. FDA will approve a new drug application (NDA) only if it determines, based on the full record before the Agency, that the product is safe and effective for the proposed conditions of use. That determination requires the review of scientific evidence that sponsors submit in support of their applications. In specified circumstances, the FDCA authorizes FDA to impose distribution and use restrictions to assure that a drug’s benefits outweigh its risks, but the statute requires the Agency to minimize the burdens of such restrictions on patient access and, to the extent practicable, the healthcare system.

Comments

Amicus: Donley, Professor Greer; Charo, Professor R. Alta; Cohen, Professor I. Glenn; Cohen, Professor Marsha N.; Cortez, Professor Nathan; Dorfman, Professor Doron; Eisenberg, Professor Rebecca S.; Greely, Professor Henry T.; Grossi, Professor Peter T.; Hall, Professor Ralph F.; Hoffman, Joel E.; Horvath, Professor George; Hutt, Professor Peter Barton; Krause, Professor Joan; Lynch, Professor Holly Fernandez; McCuskey, Professor Elizabeth; Oliva, Professor Jennifer D.; Paradise, Professor Jordan; Robertson, Professor Christopher; Sax, Professor Joanna; Whelan, Professor Allison M.; Winters, Professor Diana

Recommended Citation

Eisenberg, Rebecca S., "Brief for Food and Drug Law Scholars and Professors as Amici Curiae Supporting Petitioners and Reversal" (2024). Appellate Briefs. 5.
https://repository.law.umich.edu/briefs/5