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Association of American Physicians and Surgeons, Inc. v. United States Food and Drug Administration

September 27, 2005

ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS, INC., ET AL., PLAINTIFFS,
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Henry H. Kennedy Jr. United States District Judge

MEMORANDUM OPINION AND ORDER

This court previously ruled that a final rule promulgated by the United States Food and Drug Administration ("FDA" or "government"), which mandated pediatric testing and formulation, exceeded the FDA's statutory authority and was therefore invalid. See Ass'n of Am. Phys. & Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002). Presently before the court is plaintiffs' Motion for an Award of Attorneys' Fees and Expenses pursuant to the Equal Access to Justice Act ("EAJA"), 28 U.S.C. § 2412. Upon consideration of the motion, the opposition thereto, and the record of this case, the court concludes that the motion should be granted.

I. BACKGROUND

This lawsuit arose from plaintiffs' challenge to the FDA's promulgation of "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).*fn1 The Pediatric Rule mandated that drug manufacturers evaluate the safety and effectiveness of their products on pediatric patients, absent an applicable exception. See 21 C.F.R. § 314.55.*fn2 The Pediatric Rule was applicable to all drug manufacturers, including those who disclaimed pediatric use in a product's labeling, and even, in certain circumstances, those whose products were previously approved by the FDA. Id. § 201.23(a). Failure to comply with the Pediatric Rule entitled the FDA to declare the product to be "misbranded or an unapproved new drug or unlicensed biologic." Id. § 201.23(d).

In 1999, plaintiffs filed a citizen petition with the FDA, challenging the FDA's authority to issue the Pediatric Rule and asking the agency to revoke the rule. The FDA denied the petition in 2000. This suit, brought under the judicial review provisions of the Administrative Procedure Act, 5 U.S.C. § 551 et seq., followed.

In their pleadings before this court, plaintiffs argued that the FDA had acted beyond its statutory authority in issuing the Pediatric Rule and that the Rule directly conflicted with certain provisions of both the Food and Drug Administration Modernization Act ("FDAMA"), Pub. L. No. 105-115, 111 Stat. 2296 (1997), and its successor, the Best Pharmaceuticals for Children Act ("BPCA"), Pub. L. No. 107-109, 115 Stat. 1408 (2002). Plaintiffs alleged that the FDAMA and the BPCA evidenced a clear congressional intent that pediatric testing be conducted voluntarily rather than by the Pediatric Rule's command and control approach. The government responded by asserting that the Federal Food Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., served as the basis for the FDA's authority to issue the Pediatric Rule.

After examining specific provisions of the FDCA as well as the Act's broader context, this court concluded that the Pediatric Rule did not have a sound statutory basis in the FDCA. Ass'n of Am. Phys. & Surgeons, 226 F. Supp. 2d at 212-19. Recognizing that the FDCA's meaning "'may be affected by other Acts, particularly where Congress has spoken subsequently and more specifically to the topic at hand,'" id. at 212 (quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000)), the court then looked to the FDAMA and the BPCA to determine whether Congress intended for the FDA to promulgate the Pediatric Rule and whether the Rule "'fit[] into the overall regulatory scheme created by Congress,'" id. at 219 (quoting Brown & Williamson Tobacco Corp. v. FDA, 153 F.3d 155, 163 (4th Cir. 1998)). After a careful analysis, the court determined that the Pediatric Rule and the BPCA were incompatible. Id. at 219-22. Accordingly, the court concluded that the Pediatric Rule was beyond the FDA's statutory authority and was therefore invalid. Id. at 222.

The government opted not to appeal the court's summary judgment decision. However, the American Academy of Pediatrics and the Elizabeth Glaser Pediatric AIDS Foundation (collectively "Intervenors") requested, and were granted, leave to intervene in order to appeal. Intervenors then filed a Notice of Appeal on December 19, 2002. On December 11, 2003, after briefing on both the merits and on plaintiffs' motion to dismiss the appeal based on Intervenors' lack of standing, the court of appeals dismissed the appeal pursuant to a stipulation for voluntary dismissal signed by counsel for plaintiffs and Intervenors. The government was not a party to the appeal and did not participate in the briefings on the merits. However, the government did participate as amicus curiae, filing a brief in support of plaintiffs' motion to dismiss.

This motion for fees and expenses followed.

II. ANALYSIS

A. Legal Standard

The EAJA allows a qualified party who prevails against the United States in a civil action to recover attorneys' fees and other expenses. Specifically, the EAJA, in relevant part, provides:

[A] court shall award to a prevailing party other than the United States fees . . . incurred by that party in any civil action . . . including proceedings for judicial review of agency action, brought by or against the United States . . . unless the court finds that the position of the United States ...


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