In the Supreme Court of the United States - BRIEF FOR FOOD AND DRUG LAW SCHOLARS AND PROFESSORS AS AMICI CURIAE

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 re- quires the Agency to minimize the burdens of such restrictions on patient access and, to the extent prac- ticable, the healthcare system. [...] § 355-1).5 FDA may impose a REMS only if the Agency determines that a REMS is “necessary to ensure that the benefits of the drug outweigh the risks of the drug.” 21 U. [...] They are appropriate only when necessary to ensure that the benefits of the drug outweigh the risks.6 ETASU must be “part of [a] strategy to mitigate a specific serious risk listed in the labeling of the drug” and must be “commensurate” with this risk. [...] Such data are to be used both to assess the effectiveness of the REMS and “the im- pact of the program on the healthcare delivery system and on patient access to the drug.” Id. [...] FDA “determined that the approved REMS for Mifeprex should be modified to continue to ensure that the benefits of Mifeprex out- weigh its risks and to minimize the burden on the healthcare delivery system of complying with the REMS.” J.