Case: 23-10362 Document: 543-1 Page: 81 Date Filed: 08/16/2023
The FDA notes that its statutory authority to approve drugs comes from 21 U.S.C. § 355. But that doesn’t change the fact that the regulatory path it chose was Subpart H. Section 355 gives the FDA the power to approve drugs. And the agency exercised that power when it promulgated Subpart H. The FDA did not have to adopt Subpart H in the first place. But once it did, it was bound to follow it.
D.
As a final defense, the FDA contends that subsequent events cured any defects in its initial 2000 approval. Specifically, the FDA points to the 2007 Food and Drug Administration Amendments Act and to the agency’s 2011 Risk Evaluation and Mitigation Strategy. It claims that both authorities render any faults with the 2000 approval irrelevant.
First, the FDA argues that the 2007 Act “deemed” mifepristone to be approved. But the statutory text contradicts this argument. The Act makes clear that “[a] drug that was approved before the effective date of this Act is … deemed to have in effect an approved risk evaluation and mitigation strategy … if there are in effect on the effective date of this Act elements to assure safe use … required under [21 C.F.R. §] 314.520.” Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, tit. IX § 909(b)(1), 121 Stat. 823, 950 (emphasis added).
So the Act itself did not approve any drugs. It only approved any risk evaluation and mitigation strategies for those drugs that the FDA had already validly approved under § 314.520 of Subpart H. And as explained above, the FDA’s attempted approval was invalid because it failed to comply with Subpart H. The FDA’s reliance on the 2007 Act is entirely circular—it only works if you assume that the agency had already validly approved mifepristone in the first place.
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