Case: 23-10362 Document: 543-1 Page: 91 Date Filed: 08/16/2023
properly enforce the Food, Drug, and Cosmetic Act when it approved Purdue Pharma’s new drug application for extended-release (ER) oxycodone in 1995.” Kolodny, supra, at 744. And “despite mounting evidence that a surge in opioid consumption was resulting in adverse public health consequences, the FDA continued to approve new opioid formulations for chronic pain based on efficacy trials utilizing a controversial methodology.” Id. at 745. It wasn’t just that the studies were bad—the FDA suffered from regulatory capture by the pharmaceutical industry, which pursued its own interest rather than the interest of the American people. See id. at 745–46.
Finally, consider this statistic from the Journal of the American Medical Association: Of all the novel therapeutics approved by the FDA in the decade following its approval of mifepristone, nearly one-third experienced safety issues. See Nicholas S. Downing et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010, 317 J. Am. Med. Ass’n 1854, 1854 (2017).
Problems at the FDA have not escaped Congress’s attention. Just last year, the chair of the Senate Committee on Health, Education, Labor, and Pensions criticized the FDA for its “unacceptable, longstanding” food safety failures. Letter of Senator Patty Murray, Chair, Senate Committee on Health, Education, Labor, and Pensions to FDA Commissioner (Apr. 11, 2022). As she put it, “[t]he FDA’s failure over decades to regulate and enforce food safety standards … has put the health of Americans at risk.” Id.
So it’s not surprising that our court is far from the first to identify problems with FDA action sufficient to necessitate judicial intervention. Courts have held a number of FDA actions unlawful under the APA—including drug approval. See, e.g., Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1078 (D.C. Cir. 2001) (“Appellant argues that the [FDA’] decision to
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