Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 49 of 67 PageID 4471
- 2. FDA’s Pre-2021 Actions were Arbitrary and Capricious
Under the FFDCA, a pharmaceutical company seeking to market a new drug must first obtain FDA approval via an NDA. See 21 U.S.C. § 355(a), (b). The NDA must include “adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.” 21 U.S.C. § 355(d). The trials must “provide an adequate basis for physician labeling.” 21 C.F.R. § 312.21(c). In those trials, “the drug is used the way it would be administered when marketed.”[1] The Secretary must deny the NDA if “he has insufficient information to determine whether such drug is safe for use under such conditions.” 21 U.S.C. § 355(d)(4).
Here, the U.S. trials FDA relied upon when approving mifepristone required that: (1) each woman receive an ultrasound to confirm gestational age and exclude an ectopic pregnancy;[2] (2) physicians have experience in performing surgical abortions and admitting privileges at medical facilities that provide emergency care; (3) all patients be within one hour of emergency facilities or the facilities of the principal investigator; and (4) women be monitored for four hours to check for adverse events after taking misoprostol. ECF No. 7 at 23. However, FDA included none of these requirements — which were explicitly stated in the clinical trial FDA relied on most — in the 2000 Approval. Id. Likewise, FDA’s 2016 Changes omitted the requirements of the underlying tests: (1) gestational age confirmed by ultrasounds; (2) participants required to return for clinical assessment; and (3) surgical intervention if necessary. Id. at 24.
- ↑ Glossary, Weill Cornell Medicine, https://research.weill.cornell.edu/compliance/human-subjects-research/institutional-review-board/glossary-faqs-medical-terms-lay-3 (last visited Mar. 22, 2023) (emphasis added).
- ↑ The 2016 Denial of the 2002 Petition briefly notes the two French clinical trials did not require an ultrasound but instead left the decision to the investigator’s discretion. ECF No. 1-28 at 19 n.47. Defendants do not explain how many investigators chose to perform an ultrasound. The higher that number is, the more it supports Plaintiffs’ argument. But in any case, the U.S. trial was larger than the two French trials combined and is therefore the more reliable study. Id. at 9.
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