Public Citizen Amicus Brief in Alliance for Hippocratic Medicine v. FDA

This brief was filed on behalf of Public Citizen, a non-profit consumer advocacy organization with members in all fifty states which, among other things, works to advance access to health care and to ensure strong protections for public health.

The brief emphasizes that the FDA engages in rigorous and ongoing expert study of detailed scientific evidence when considering whether and under what conditions a drug is safe and effective for use. The brief further states that the FDA’s robust processes ensure that it will rarely, if ever, be arbitrary or capricious for the FDA to deny a citizen petition that seeks withdrawal of approval or REMS decisions without presenting new evidence and the FDA’s denial of plaintiffs’ 2019 citizen petition challenging the 2016 REMS modifications was not arbitrary or capricious because the petition simply disagreed with the FDA’s expert assessment of the evidence and offered virtually no new evidence of its own.

This brief was one of many filed in Alliance for Hippocratic Medicine v. FDA. For more information on the case, click here.