Case: 23-10362 Document: 543-1 Page: 92 Date Filed: 08/16/2023
approve … [an] Abbreviated New Drug Application (ANDA) for a generic version … was arbitrary and capricious. We agree and vacate that approval.”). See also, e.g., R.J. Reynolds Vapor Co. v. FDA, 65 F.4th 182, 191 (5th Cir. 2023) (FDA’s “‘unexplained’ and ‘inconsistent’ positions are likely arbitrary and capricious.”); Genus Medical Technologies, LLC v. FDA, 994 F.3d 631, 644 (D.C. Cir. 2021) (“FDA’s decision must be set aside because it was based on an erroneous interpretation of law.”); Teva Pharmaceuticals, Inc. v. Sebelius, 595 F.3d 1303, 1318 (D.C. Cir. 2010) (rejecting “the interpretation of the statute that the FDA has adopted in two recent adjudications”); Teva Pharmaceuticals, Inc. v. FDA, 441 F.3d 1, 5 (D.C. Cir. 2006) (“This error renders [the FDA’s] decision arbitrary and capricious.”); Purepac Pharmaceutical Co. v. Thompson, 354 F.3d 877, 883–84 (D.C. Cir. 2004) (“FDA’s conclusion … was arbitrary and capricious.”); Teva Pharmaceuticals, Inc. v. FDA, 182 F.3d 1003, 1007 (D.C. Cir. 1999) (“FDA’s response was arbitrary and capricious.”); Zotos International, Inc. v. Young, 830 F.2d 350, 354 (D.C. Cir. 1987) (“FDA’s decision was arbitrary and capricious.”); Rhodia, Inc. v. FDA, 608 F.2d 1376, 1376 (D.C. Cir. 1979) (“Finding the action arbitrary and capricious, we set aside the FDA order.”); Natural Nutritional Foods Ass’n v. Mathews, 557 F.2d 325, 333 (2nd Cir. 1977) (“[T]he FDA’s holding in this case was arbitrary and capricious and not in accordance with law.”).
So it’s simply wrong to claim—as the FDA and Danco and their supporting amici here have claimed—that the district court’s decision in this case was unprecedented.
The scientists at the FDA deserve our respect and our gratitude, but not our blind deference. That would defy Congress’s clear directive that courts conduct independent legal review of FDA action under the APA.
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