Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2181 Page 20 of 31
not be unduly burdensome on patient access to the drug, considering in particular – patients with serious or life-threatening diseases or conditions; patient who have difficulty accessing health care (such as patients in rural or medically underserved areas); and patients with functional limitations; and to the extent practicable, so as to minimize the burden on the health care delivery system – conform with [ETASU] for other drugs with similar, serious risks; and be designed to be compatible with established distribution, procurement, and dispensing systems from drugs.
21 U.S.C. § 355-1(f)(2)(C)–(D).
Plaintiffs contend that mifepristone no longer requires a REMS program with ETASU. ECF Nos. 3 at 19–21, 23–24; 60 at 11. Plaintiffs assert that (1) FDA acknowledges that serious adverse events are “exceedingly rare”, (2) mifepristone’s associated fatality rate is .00005%, with not a single death “casually attributed to mifepristone”(3) “all the data shows the mifepristone is among the safest drugs in the world, and safer than the vast majority of drugs for which FDA has never attempted to impose a REMS”, and (4) “there is no reasoned scientific basis for subjecting it to additional burdens that are not applied to other, riskier medications.” See id. Defendants do not address whether mifepristone qualifies for ETASU, asserting it need only determine whether modifications are appropriate under 21 U.S.C. § 355-1(g)(4)(B). See ECF Nos. 51 at 25; 78 at 22.
The FDA may modify or remove an approved REMS, including ETASU, if it determines “1 or more goals or elements should be … modified, or removed from the approved strategy [in part] to ensure the benefits of the drug outweigh the
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 20
