Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2164 Page 3 of 31
actions by Defendants to remove this critical drug from the market, and enjoin[] the unnecessary and burdensome January 2023 restrictions.” ECF No. 3 at 5. The parties timely filed their respective response and reply. ECF Nos. 51, 60. The following facts are generally undisputed for purposes of resolving the instant motion.
In 1992, Subpart H regulations authorized the Food and Drug Administration (“FDA”) to require conditions “needed to assure safe use” for certain drugs. Final Rule, 57 Fed. Reg. 58,942, 58,958 (December 11, 1992) (codified at 21 C.FR. § 314.520). In September 2000, FDA approved mifepristone1 under Subpart H, concluding that mifepristone[1] is safe and effective for medical termination of intrauterine pregnancy through 49 days’ gestation when used in a regimen with the already-approved drug, misoprostol. ECF No. 35 at 21, ¶ 85. FDA’s restrictions on mifepristone included requiring (1) an in-person dispensing requirement where the drug could only be dispensed in a hospital, clinic, or medical office, by or under the supervision of a certified provider who at the time could only be a physician, (2) providers attest to their clinical abilities in a
- ↑ As referenced herein, mifepristone is the drug used for early termination of pregnancy, such as Mifeprex and the generic drug. This Order does not impact mifepristone as used in Korlym, a drug used to treat Cushing’s syndrome.
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 3
