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 ...