Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 60 of 67 PageID 4482
different conditions than the tests, trials, and studies cited. To be clear, the Court does not hold that any difference between approval conditions and testing conditions — no matter how well-justified — means the approval fails as a matter of law. But the agency “must cogently explain why it has exercised its discretion in a given manner,” and that explanation must be “sufficient to enable [the Court] to conclude that the [agency’s action] was the product of reasoned decisionmaking.” A.L. Pharma, 62 F.3d at 1491 (quoting State Farm, 463 U.S. at 52). Defendants have not done so here. FDA’s 2016 Actions were not the product of reasoned decision-making.
- c. The 2019 Generic Approval
The FFDCA allows a generic drug manufacturer to submit an ANDA for premarket review and approval. 21 U.S.C. § 355(j); 21 C.F.R. § 314.94. The generic sponsor must show that: (1) the conditions of use prescribed, recommended, or suggested in the labeling have been previously approved; and (2) the drug product is chemically the same as the already approved drug — allowing it to rely on FDA’s previous finding of safety and effectiveness for the approved drug. Id. On April 11, 2019, FDA approved GenBioPro, Inc.’s ANDA for a generic version of mifepristone. ECF No. 7 at 10. In doing so, FDA relied on Mifeprex’s safety data. Id.
Plaintiffs argue the 2019 Approval was unlawful because FDA relied on the unlawful 2000 Approval and its unlawful 2016 Changes when approving generic mifepristone. ECF No. 7 at 27. If FDA withdraws the listed drug on which the ANDA-approved generic drug is based, the agency is generally required to withdraw the generic drug as well. 21 U.S.C. § 355(j)(6); 21 C.F.R. § 314.151. Because the Court agrees that Plaintiffs have a substantial likelihood of success in their challenges to the 2000 and 2016 Actions, the Court is inclined to agree with Plaintiffs on this claim as well.
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