Case Document Type
IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK
FIFTH AMENDED COMPLAINT
Plaintiffs, by and through their undersigned attorneys, bring this complaint against the defendant, his agents and successors in office, and in support thereof aver the following:
1. This is a challenge under the Administrative Procedures Act (APA) and the United States Constitution to the denial by the Food and Drug Administration (FDA) of a Supplemental New Drug Application (SNDA) and a citizen petition (“citizen petition”) seeking to switch the emergency contraception (“EC”) drug Plan B from prescription-only availability to unrestricted over-the-counter status (“OTC switch”) and to the establishment by the FDA of an agerestricted, behind-the-pharmacy-counter, dual prescription/nonprescription regime for Plan B (“BTC regime”). Plaintiffs claim that the BTC regime and the denial of the OTC switch violate their rights and the rights of women who need Plan B to privacy and equal protection under the Fifth Amendment, and that the BTC regime and the denial of the OTC switch violate their rights and the rights of women who need Plan B because it exceeds the statutory authority of the FDA and is arbitrary and capricious. Plaintiffs seek injunctive relief requiring the defendant to approve the OTC switch for women of all ages, or such other equitable relief as the Court may deem appropriate, and a declaratory judgment that the FDA’s denial violates the APA and violates the constitutional rights of women who need Plan B.