Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 21 of 67 PageID 4443
of Navy, 757 Fed. Appx. 172, 175 (3d Cir. 2018) (a petition for reconsideration can restart Section 2401(a)’s limitation period if the agency reopens the action based on a finding of “new evidence” or that the petition reflects some “changed circumstances”); Peavey v. United States, 128 F. Supp. 3d 85, 100 (D.D.C. 2015), aff’d, No. 15-5290, 2016 WL 4098768 (D.C. Cir. 2016) (reopening in 2011 occurred where agency “elected to conduct a substantive review” of servicemember’s 1968 application to correct military records). For formal agency adjudications, even an order stating “only that it is denying reconsideration” is not conclusive if the agency has “altered its original decision.” Sendra Corp. v. Magaw, 111 F.3d 162, 167 (D.C. Cir. 1997).
The standard for reopening is satisfied here. FDA’s requirements for distribution in its 2000 Approval originally included:
- In-person dispensing from the doctor to the patient;
- Secure shipping procedures;
- Tracking system ability;
- Use of authorized distributors and agents; and
- Provision of the drug through direct, confidential physician distribution systems that ensures only qualified physicians will receive the drug for patient dispensing.
See ECF No. 1 at 40. FDA’s 2016 Changes to this regulatory scheme included the following alterations:
- Extending the maximum gestational age at which a woman or girl can abort her unborn child from 49 days to 70 days;
- Altering the mifepristone dosage from 600 mg to 200 mg, the misoprostol dosage from 400 mcg to 800 mcg, and misoprostol administration from oral to buccal;
- Eliminating the requirement that administration of misoprostol occur in-clinic;
- Broadening the window for misoprostol administration to include a range of 24–48 hours after taking mifepristone, instead of 48 hours afterward;
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