Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/39

 and 2021 Petition Denial each trigger reopening. We disagree.

The Medical Organizations and Doctors point both to FDA’s denial of their 2002 citizen petition and to the agency’s approval of the amendments to mifepristone’s conditions for use. They argue that, when FDA denied the citizen petition, it denied their request to rescind approval of mifepristone. And when FDA approved the 2016 Amendments, it altered the regime by which mifepristone is prescribed and used. Taken together, they say, these actions show that FDA substantively reconsidered the 2000 Approval.

To begin, the 2016 petition denial does not inform the 2016 Amendments. They are plainly different in nature; the former reaffirms FDA’s conclusion that the agency properly approved mifepristone for use in 2000 and the latter considers relaxed conditions for the drug’s use. The Medical Organizations and Doctors likely could have challenged the 2000 Approval if they had timely filed suit in response to the petition denial. But they did not. The argument that the two decisions must be considered in tandem is really just an end-run around the fact that the Medical Organizations and Doctors were too late to challenge FDA’s denial of their citizen petition.

Accordingly, we consider only whether the 2016 Amendments themselves give rise to the reopening doctrine. They do not. Nothing in FDA’s approval of the amendments shows that it undertook a “serious, substantive reconsideration” of the 2000 Approval. Texas v. Biden, 20 F.4th 928,