Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 39 of 67 PageID 4461
ECF No. 7 at 25. Defendants maintain that “Plaintiffs offer no explanation for why it was impermissible to rely on the reported data.” ECF No. 28 at 33. The explanation should be obvious — it is circular and self-serving to practically eliminate an “adverse event” reporting requirement and then point to a low number of “adverse events” as a justification for removing even more restrictions than were already omitted in 2000 and 2016. In other words, it is a predetermined conclusion in search of non-data — a database designed to produce a null set. But even if FDA’s explanation were well-reasoned, the actions would still run afoul of the Comstock Act and therefore violate the APA.
- D. Plaintiffs’ Challenges to FDA’s Pre-2021 Actions Have a Substantial Likelihood of Success on the Merits
- 1. FDA’s 2000 Approval violated Subpart H
In 1992, FDA issued regulations “needed to assure safe use” of new drugs designed to treat life-threatening diseases like HIV and cancer. See 57 Fed. Reg. 58,942, 58,958 (Dec. 11, 1992) (codified at 21 C.F.R. § 314.520). Subpart H — titled “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses” — applies to drugs that satisfy two requirements. First, the drug must have been “studied for [its] safety and effectiveness in treating serious or life-threatening illnesses.” 21 C.F.R. § 314.500. And second, the drug must “provide [a] meaningful therapeutic benefit to patients over existing treatments.” Id. “These rules were promulgated by FDA … as part of an attempt to correct perceived deficiencies in FDA’s approval process made apparent by the need to quickly develop drugs for HIV/AIDS patients.” ECF No. 1-13 at 20.
“When FDA originally approved Mifeprex, the agency relied upon Subpart H to place certain restrictions on the manufacturer’s distribution of the drug product to assure its safe use.” ECF No. 28 at 14; see also ECF No. 1-13 at 9 (the American Medical Association explained that “[Mifepristone] poses a severe risk to patients unless the drug is administered as part of a complete
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