Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 22 of 67 PageID 4444
- Adding a repeat 800 mcg buccal dose of misoprostol in the event of incomplete chemical abortion;
- Removing the requirement for an in-person follow-up examination after an abortion;
- Allowing “healthcare providers” other than physicians to dispense and administer the chemical abortion drugs; and
- Eliminating the requirement for prescribers to report all non-fatal serious adverse events from chemical abortion drugs.
Id. at 53–54. And in 2021, FDA removed the “in-person dispensing requirement” and signaled that it will soon allow pharmacies to dispense chemical abortion drugs. Id. at 68. Plaintiffs warn that without this requirement, “there is a dramatically reduced chance that the prescriber can confirm pregnancy and gestational age, discover ectopic pregnancies, and identify a victim of abuse or human trafficking being coerced into having a chemical abortion.” ECF No. 120 at 19.
FDA’s 2016 and 2021 Changes thus significantly departed from the agency’s original approval of the abortion regimen. FDA repeatedly altered its original decision by removing safeguards and changing the regulatory scheme for chemical abortion drugs. Sierra Club, 551 F.3d at 1025; Nat’l Biodiesel, 843 F.3d at 1017. Additionally, FDA’s response to the 2019 Petition explicitly states FDA “undertook a full review of the Mifepristone REMS Program” in 2021. ECF No. 1-44 at 7 (emphasis added);[1] see also Peavey, 128 F. Supp. 3d at 100–02 (agency reopened decision by conducting “thorough review” of the merits, even where the order did not state it was a “reconsideration” and did not reference prior decision). And FDA even granted the 2019 Petition in part. ECF No. 1-44 at 3. A “full review” of a REMS for a drug with known serious risks necessarily considers the possibility that a drug is too dangerous to be on the market, any mitigation
- ↑ See also Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, FDA (Jan. 4, 2023), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation (describing the 2021 review as “comprehensive”).
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