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 signed form kept on file by the manufacturer, and agree to comply with reporting and other REMS requirements, and (3) prescribers and patients review and sign a form with information about the regimen and risks and that the prescriber provide copies to the patient and patient’s medical record. Id. at 24, ¶ 87.

From 1992 to February 2002, seven New Drug Applications (“NDA”), including Mifeprex, were approved subject to these conditions, in contrast to the 961 NDAs with no additional restrictions from January 1993 to September 2005. ECF No. 35 at 24–25, ¶ 88.

The Food and Drug Administration Amendments Act of 2007 effectively replaced Subpart H with the REMS statute codified at 21 U.S.C. § 355-1. Pub. L. No. 110-85, tit. IX, § 901. All drugs previously approved under Subpart H, including Mifeprex, were deemed to have a REMS in place. Pub. L. No. 110-85, tit. IX, § 909(b). Under the Federal Food, Drug and Cosmetic Act (“FDCA”), a new drug cannot be marketed and prescribed until it undergoes a rigorous approval process to determine that it is safe and effective. 21 U.S.C. § 355.

In 2011, FDA issued a new REMS for Mifeprex incorporating the same restrictions under which the drug was approved eleven years earlier. Id., ¶ 90; ECF No. 51-2. In 2013, FDA reviewed the existing REMS and reaffirmed the restrictions in place. ECF No. 35 at 25, ¶ 91.