Case: 23-10362 Document: 543-1 Page: 90 Date Filed: 08/16/2023
science for approval under one Subpart H pathway can surely do so under the other as well.)
The FDA hasn’t just approved ineffective drugs—it’s also approved harmful drugs. In 1941, for example, it approved DES for use by pregnant women to treat certain postpartum conditions. Several years later, the FDA approved it to prevent miscarriages as well. The FDA’s approval has since been called a “tragedy.” Jessica Dye, FDA Outlines Initiatives Inspired by DES ‘Tragedy’, Law360 (Feb. 24, 2011). “Even before the [FDA] approved the drug in 1941, researchers knew that DES caused cancer and problems with sexual development in laboratory animals.” Nancy Langston, The Retreat from Precaution: Regulating Diethylstilbestrol (DES), Endocrine Disruptors, and Environmental Health, 13 Environmental History 41, 42 (2008). “These concerns initially led [the] FDA Commissioner … to reject the drug.” Id. But “by 1947, the FDA had abandoned its position of precaution.” Id.
Only in 2000 did FDA finally and formally “withdraw[] approval” of DES—nearly six decades after it approved the drug. 65 Fed. Reg. 55264 (“Withdrawal of Approval of 28 New Drug Applications”). DES turned out to be a carcinogen. See Diethylstilbestrol (DES) Exposure and Cancer, Nat’l Cancer Inst. (Dec. 20, 2021). It also significantly increases the odds of infertility, miscarriage, stillbirth, and neonatal death. See id.
The FDA has been blamed for contributing to the opioid crisis. Opioid overdose was “once rare” in the United States. Andrew Kolodny, How FDA Failures Contributed to the Opioid Crisis, 22 AMA J. Ethics 743, 743 (2020). But now “the vast oversupply of opioid drugs in the United States has caused a plague.” In re Nat’l Prescription Opiate Litigation, 927 F.3d 919, 924 (6th Cir. 2019) (approvingly quoting the district court). As one noted scholar observed in the AMA Journal of Ethics, “[t]he FDA did not
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