Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2180 Page 19 of 31
to ensure that the benefits of the drug outweigh the risks of the drug.” 21 U.S.C. § 355-1(a)(1). An existing REMS may be modified or removed to “ensure the benefits of the drug outweighs the risks of the drug [or] minimize the burden on the health care delivery system of complying with the strategy.” 21 U.S.C. § 355-1(g)(4)(B).
Moreover, a REMS may include elements that are necessary to assure safe use [ETASU] due to a drug’s “inherent toxicity or potential harmfulness” if the drug has “been shown to be effective, but is associated with a serious adverse drug experience, can be approved only if, or would be withdrawn unless, such elements are required as part of such strategy to mitigate a specific serious risk listed in the labeling of the drug.” 21 U.S.C. § 355-1(f)(1)(A). A “serious adverse drug experience” is one that results in:
death; an adverse drug experience that places the patient at immediate risk of death…; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or a congenital anomaly or birth defect; or based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical intervention to prevent [such] an outcome.
21 U.S.C. § 355-1(b)(4)(A).
If the FDA determines ETASU is required, the ETASU shall:
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 19
