Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 57 of 67 PageID 4479
full agreement about the distribution restrictions” and that fulfilling the Phase 4 commitments “would not be feasible.” ECF No. 1-28 at 18, 32–33.
The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased “access” to chemical abortion — which was the “whole idea of mifepristone.”[1] As President Clinton’s Secretary for Health & Human Services (“HHS”) explained to the White House, it was FDA that arranged the meeting between the French pharmaceutical firm — who owned the mifepristone patent rights — and the eventual drug sponsor Population Council. The purpose of the FDA-organized meeting was “to facilitate an agreement between those parties to work together to test [mifepristone] and file a new drug application.” ECF No. 95 at 14. HHS also “initiated” another meeting “to assess how the United States Government” — i.e., the Clinton Administration — “might facilitate successful completion of the negotiations” between the French firm and the American drug sponsor to secure patent rights and eventual FDA approval. Id. at 16. In fact, for their “negotiations [to be] successfully concluded,” the HHS Secretary believed American pressure on the French firm was necessary.[2] Id.
Whether FDA abandoned its proposed restrictions because of political pressure or not, one thing is clear: the lack of restrictions resulted in many deaths and many more severe or life-
- ↑ Stolberg, supra note 59.
- ↑ See also Lars Noah, A Miscarriage in the Drug Approval Process?: Mifepristone Embroils the FDA in Abortion Politics, 36 Wake Forest L. Rev. 571, 576 (2001) (“The Clinton administration went to great lengths to bring mifepristone into the United States. From pressuring the hesitant manufacturer to apply for approval, and utilizing a specialized review procedure normally reserved for life-saving drugs, to imposing unusual restrictions on distribution, and promising to keep the identity of the manufacturer a secret, the FDA’s approval process deviated from the norm in several respects.”).
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