Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 55 of 67 PageID 4477
Similarly, on February 18, 2000 — months before chemical abortion approval — FDA informed the Population Council that “adequate information ha[d] not been presented to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.” ECF No. 1-24 at 6 (emphasis added). FDA then stated the “restrictions on distribution will need to be amended.” Id. Accordingly, FDA informed the Population Council that it would proceed under Subpart H — the only provision that could implement the requisite restrictions on distribution. Id. But as explained above, that was the improper regulation for the approval of chemical abortion. Regardless, the restrictions were insufficient to ensure safe use.
On June 1, 2000, FDA privately delivered to the Population Council a set of proposed restrictions to rectify the safety issues. Said proposal required physicians who were: (1) “trained and authorized by law” to perform surgical abortions; (2) trained in administering mifepristone and treating adverse events; and (3) allowed “continuing access (e.g., admitting privileges) to a medical facility equipped for instrumental pregnancy termination, resuscitation procedures, and blood transfusion at the facility or [one hour’s] drive from the treatment facility.” See ECF No. 1-14 at 53–54. When FDA’s proposal was leaked to the press, a political and editorial backlash ensued.[1] In response, the Population Council rejected the proposal and repudiated the restrictions the sponsor itself proposed in 1996 — what FDA deemed a “very significant change” in the sponsor’s position. Id. at 50. Because “[t]he whole idea of mifepristone was to increase access,” abortion advocates argued that restrictions on mifepristone “would effectively eliminate” the drug’s “main advantage” and would “kill[] the drug.”[2]
- ↑ Sheryl Gay Stolberg, FDA Adds Hurdles in Approval of Abortion Pill, The New York Times (June 8, 2000), https://www.nytimes.com/2000/06/08/us/fda-adds-hurdles-in-approval-of-abortion-pill.html.
- ↑ Id.
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