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April 20, 1999


The opinion of the court was delivered by: Robertson, District Judge.


The Food and Drug Administration Modernization Act of 1997 (FDAMA), codified as 21 U.S.C. § 355a, provides a 6-month extension of the statutory market exclusivity given to a new drug if, upon FDA's request, the manufacturer studies the effect of the drug on children. The plaintiffs in this case, two trade associations of generic drug manufacturers, complain that FDAMA is being misapplied. They seek to enjoin the Food and Drug Administration from granting further 6-month extensions and from issuing further written requests for pediatric studies.*fn1 Before the Court now is plaintiffs' application for preliminary injunction. This memorandum sets forth reasons for the Court's findings, after a hearing, that, on the merits of their claim, plaintiffs have not demonstrated that FDA's interpretation of the statute in question is unreasonable, and that plaintiffs have not made the very strong showing of irreparable injury that would be necessary to support a preliminary injunction in view of their scant likelihood of success on the merits. The application for preliminary injunction will be denied.


The pediatric exclusivity provision of FDAMA took. effect on November 21, 1997. On March 16, 1998, in compliance with section 355a(b), FDA published a "Draft Pediatric List" of approved drugs for which it suggested that additional pediatric information might produce health benefits in the pediatric population. FDA solicited input from American Academy of Pediatrics, Pharmaceutical Research and Manufacturers of America, both plaintiffs, National Institutes of Health, Pediatric Pharmacology Research Units Network, National Association of Pharmaceutical Manufacturers (a generic trade association), and U.S. Pharmacopoeia. On May 20, 1998, within the 180-day period prescribed by section 355a(b), FDA published a final "List of Approved Drugs for Which Additional Pediatric Information May Produce Health Benefits in the Pediatric Population" [the "Pediatric List"]. On July 7, 1998, the FDA issued a document entitled "Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act" [the "Guidance document"].

FDA has neither issued nor proposed regulations for implementing section 355a. It began issuing written requests for pediatric studies on specific drugs soon after publication of the Guidance document.

Plaintiffs brought this lawsuit on February 19, 1999. The complaint alleges that FDA developed the Pediatric List improperly and that FDA's interpretation of the pediatric exclusivity provisions of Section 355a is at variance with the statute. The arguments presented at a hearing on plaintiffs' motion for preliminary injunction held on April 9, 1999, focused mostly on plaintiffs' objection to FDA's position, set forth in the Guidance document and now implemented by the issuance of one or more 6-month extensions, that additional market exclusivity may be given to a manufacturer's entire line of drug products having the same active moiety in exchange for a pediatric study conducted on only one drug product. Plaintiffs urge that such an exchange "frustrates incentives for pediatric research by conferring lucrative benefits on `innovator' drug manufacturers that are completely out of proportion to the useful pediatric data generated in return." Pl. Reply Br. at 1.


To obtain a preliminary junction, the moving party must satisfy the elements of the familiar four-part test set forth in many decisions, including CityFed Fin. Corp. v. Office of Thrift Supervision, 58 F.3d 738, 746 (D.C.Cir. 1995).

Likelihood of success on the merits

The principal issue on the merits, as indicated above, is whether FDA has authority to grant additional exclusivity periods for drug product lines containing a single active moiety in exchange for a pediatric study covering a single drug product. The issue must be analyzed by asking the two questions mandated by Chevron, U.S.A. v. Natural Resources Defense Council, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). The answer to the first question, "whether Congress has directly spoken to the precise question at issue," id. at 842, 104 S.Ct. 2778, is a simple no. Plaintiffs attempt to argue that "the intent of Congress is clear," Pl. Reply Br. at 11-12, and that the word "drug" as used in section 355a must refer to a specific "drug product" because that is the sense in which the words is always used for New Drug Applications, Pl.Br. at 16-20. FDA responds that its interpretation of section 355a is consistent with the overall structure of regulation of generic drugs, as set forth in the Hatch-Waxman Amendments, Pub.L. 98-417, 98 Stat. 1585 (1984), which Congress knew about when it enacted FDAMA. The main arguments of both sides focus, correctly, on the FDA's interpretation of the statute. Neither the language of section 355a nor anything in the nature of legislative history speaks directly to the question at issue.

The second, and controlling, Chevron question is whether FDA's interpretation of section 355a is "based on a permissible construction of the statute." 467 U.S. at 843, 104 S.Ct. 2778. Plaintiff asserts that it is not, arguing that FDA has departed from other, consistent interpretations of the term "drug" throughout the Food Drug and Cosmetics Act to mean "drug product," Pl.Br. at 17-18, that Congress wanted extended pediatric exclusivity to be limited to the "drug product" studied in response to a request from FDA, Pl.Br. at 18-19, and that FDA's construction conflicts with the statutory purpose of maximizing information about the use of drugs in children by removing the incentive to conduct research, Pl.Br. at 19-20. There is little in the way of substantive information in this record, however, that supports these arguments. Congress did not prescribe the exact terms of the bargain it wanted struck with the research-based drug companies, leaving it to FDA to strike the appropriate balance. Absent some compelling reason why FDA's determination is not entitled to the deference normally accorded to regulatory agencies in questions of this sort, the second Chevron question must be answered, yes.

Plaintiffs present two arguments why FDA's interpretation is entitled to no deference, or to reduced deference. They argue, first, that less deference is owed to an agency's interpretation of a statute than to, say, a scientific decision. Chevron deference, however, is clearly owed to an agency's interpretation of its governing statute. See Chevron, 467 U.S. at 844, 104 S.Ct. 2778 ("We have long recognized that considerable weight should be accorded to an executive department's construction of a statutory scheme it is entrusted to administer, and the principle of deference to administrative interpretations.") (Citation omitted.)

Plaintiffs' second argument is that no deference is owed to an agency's interpretation of a statutory ambiguity if the agency itself has taken inconsistent opinions. Plaintiffs assert that the FDA's brief at pages 14 and 17 contradicts the Guidance document's statement that "[p]ediatric exclusivity will attach to . . . any drug product containing the same active moiety as the drug studied. . . ." Pl.Br., Ex. C at 12. Just as courts may not accept as the rationale of an agency the arguments found in legal briefs, however, see Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 50, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983), so they should not find inconsistency in an agency's rationale because of the language found in legal briefs — particularly briefs written under the time pressure of a preliminary injunction hearing schedule.

Plaintiffs advance at least two other arguments in their briefs that were given little emphasis at the April 9 hearing. One of these arguments is that FDA acted arbitrarily and capriciously by including in the Pediatric List every drug approved for use in adults for indications that also appear in children.*fn2 ...

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