Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 48 of 67 PageID 4470
- d. Defendants’ Misapplication of Subpart H has not been Cured by Congress
Defendants contend “Plaintiffs’ arguments about Subpart H have been overtaken by congressional action.” ECF No. 28 at 35. In the FDAAA, “Congress specifically directed” that drugs with elements to assure safe use “in effect on the effective date on this Act” would be “deemed to have in effect an approved” REMS. Id. (citing Pub. L. No. 110-85, § 909(b)(1)). But the sponsors of such drugs were also required to submit a proposed REMS within 180 days. See Pub. L. No. 110-85, § 909(b)(3). Hence, Congress “deemed” preexisting safety requirements to be a sufficient REMS until a new REMS was approved. The FDAAA did not affect, however, whether an NDA was properly approved or authorized under Subpart H in the first place. Rather, the FDAAA required that such drugs needed continued restrictions in place to mitigate risks. Implementation of a REMS under the FDAAA does not somehow repeal or supplant the approval process under Subpart H or 21 U.S.C. § 355(d). The FDAAA only eased the regulatory transition from Subpart H to the REMS provision. Simply stated, Congress’s general reiteration that dangerous drugs should carry a REMS did not codify FDA’s specific approval of the mifepristone NDA. It did not consider the chemical abortion approval at all.
In sum, Subpart H doubly forecloses FDA’s approval of mifepristone. At most, FDA might have lawfully approved mifepristone under Subpart H for cases where a pregnant woman’s life or health is in danger. But even a limited approval of this sort would still not render pregnancy an “illness.” And surgical abortion — a statistically far safer procedure — would still be available to her. But in any case, that is not what FDA did. Instead, FDA manipulated and misconstrued the text of Subpart H to greenlight elective chemical abortions on a wide scale. Therefore, Plaintiffs have a substantial likelihood of prevailing on their claim that Defendants violated Subpart H.
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