Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/8

 over the next fourteen years, ultimately denying it in 2016.

Two significant developments occurred in the meantime. First, in 2007, Congress amended the Food, Drug, and Cosmetic Act. See Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, tit. IX, § 901, 121 Stat. 823, 922–43. The amendment authorizes FDA to require a “risk evaluation and mitigation strategy” (REMS) if it determines that such a strategy is “necessary to ensure that the benefits of the drug outweigh the risks of the drug.” 21 U.S.C. § 355-1(a)(1). The Act further allowed FDA to impose use restrictions via the REMS, like physician qualifications or reporting requirements. Id. § 355-1(f). The law also regarded all drugs approved before the Act as having an approved REMS. See Amendments Act § 909(b), 121 Stat. at 950 (“A drug that was approved before the effective date of this Act is … deemed to have in effect an approved risk evaluation and mitigation strategy under section 505-1 of the [Act].”).

Then in 2011, FDA approved a REMS for mifepristone, imposing essentially the same restrictions as those FDA required when it approved Mifeprex in 2000. The REMS included four essential parts: a general summary, medication guide, prescriber agreement, and patient agreement. The medication guide explains how to use mifepristone and the risks associated with doing so. Mifepristone REMS at 4–6 (June 8, 2011). The prescriber agreement requires prescribers to promise to follow FDA’s restrictions. Id. at 7–8. And the patient agreement is a form that women must sign prior to using mifepristone; it obliges a patient to confirm that she meets the conditions for using mifepristone and acknowledge the risk of adverse events. Id. at 9–10. The mifepristone REMS was later amended in several respects. But its general form—the summary, medical guide, prescriber’s agreement, and patient agreement—remains the same.

In 2016, FDA addressed Mifeprex in two respects. First, it denied the