Case: 23-10362 Document: 543-1 Page: 89 Date Filed: 08/16/2023
Congress could have exempted the FDA generally—or its approval of drugs specifically—from APA review. See 5 U.S.C. § 701(a)(1) (no APA review where “statutes preclude judicial review”). But it didn’t—and for understandable reasons.
Scientists have contributed an enormous amount to improving our lives. But scientists are human beings just like the rest of us. They’re not perfect. See, e.g., Whole Woman’s Health v. Paxton, 10 F.4th 430, 464–70 (5th Cir. 2021) (en banc) (Ho, J., concurring). None of us are. We all make mistakes.
And the FDA has made plenty. Several of the FDA’s past mistakes are detailed in the amicus briefs from the United States Medical Association and the Association of American Physicians and Surgeons Educational Foundation. I’ll highlight just a few examples here.
Earlier this year, the FDA was forced to pull the drug Makena from the market. See FDA News Release: FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena (Apr. 6, 2023). The FDA had approved this drug in 2011 to treat premature birth, using Subpart H. See Frank J. Sasinowski & Alexander J. Varond, FDA’s Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence, 71 Food & Drug L.J. 135, 167 (2016). Yet the drug turned out to have “no benefit for mothers or babies.” Christina Jewett, Preterm Birth Drug Withdrawn After 12 Years, N.Y. Times (Mar. 7, 2023). As one headline put it, “F.D.A. Rushed a Drug for Preterm Births. Did it Put Speed Over Science?” Christina Jewett, N.Y. Times (Mar. 25, 2022). “Makena is another example … of a medication fast-tracked by the [FDA] onto the market even though considerable doubt remained about whether it worked.” Id. (Makena involved the other Subpart H approval pathway—approval with a surrogate endpoint, not approval with restrictions. But an agency that relies on bad
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