CEI Obtains Victory Over FDA In Court Challenge To Its Pediatric Rule

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Plaintiffs, Association of American Physicians and Surgeons (“AAPS”), Competitive Enterprise Institute (“CEI”), and Consumer Alert, bring this lawsuit to challenge the authority of the United States Food and Drug Administration (“FDA”) to promulgate “Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients” (“Pediatric Rule”), 21 C.F.R. §§ 201, 312, 314, 601, 63 Fed. Reg. 66,632 (Dec. 2, 1998). Plaintiffs claim that the Pediatric Rule exceeds the FDA’s statutory authority and that the Rule’s promulgation was arbitrary and capricious. Plaintiffs thus petition this court for relief pursuant to the Administrative Procedure Act (“APA”), 5 U.S.C. § 701 et seq.


Before this court are the parties’ cross-motions for summary judgment. Upon consideration of the parties’ submissions and the summary-judgment record, the court concludes that defendants’ motion for summary judgment must be denied and plaintiffs’ motion for summary judgment must be granted.