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
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 That
argument is easily resolved by appropriate deference to the
expertise of FDA.
Plaintiffs further contend that the Guidance document is a
"substantive" or "legislative" rule that should have been enacted
through notice and comment rulemaking, pursuant to the
Administrative Procedure Act, 5 U.S.C. § 553. A rule is
legislative, rather than interpretive, if any one of four
questions is answered in the affirmative:
"(1) whether in the absence of the rule there would
not be an adequate legislative basis for . . . agency
action to confer benefits or ensure the performance
(2) whether the agency has published the rule in the
Code of Federal Regulations,
(3) whether the agency has explicitly invoked its
general legislative authority, or
(4) whether the rule effectively amends a prior
American Mining Congress v. Mine Safety & Health
Admin., 995 F.2d 1106, 1112 (D.C.Cir. 1993).
Only the first question is germane in this instance, and it must
be answered in the negative. The statute on its face provides all
the "legislative basis" that is necessary for the agency's
The second factor of the four-part test is irreparable injury.
"Probability of success is inversely proportional to the degree
of irreparable injury evidenced." Cuomo v. United States Nuclear
Regulatory Comm'n, 772 F.2d 972, 974 (D.C.Cir. 1985) (per
curiam). Here, because the likelihood of success is slim,
plaintiffs would have to make a very substantial showing of
severe irreparable injury in order to prevail on their motion.
They have failed to do so. A 1995 report of the economic impact
of GATT patent extension on currently marketed drugs establishes
the general proposition that generic drug manufacturers will not
realize profits from the sale of their products over the
six-month periods of market exclusivity, but that effect was
obviously contemplated by Congress when it enacted FDAMA.
Plaintiffs have not shown that the loss of six months would allow
the creation of impenetrable barriers to market entry or cause
business failures among generic manufacturers.
The public interest and harm to the parties
FDAMA has a sunset provision for the year 2002. A report is due
to Congress in 2001. The legislative incentive for the conduct of
important pharmaceutical testing — which is not otherwise
required of drug manufacturers — is thus of limited duration. The
injunction prayed for would prevent FDA from issuing written
requests for pediatric testing. Because an FDA written request is
a prerequisite of the six-month protection provided by section
355a, drug manufacturers would have no reason to initiate testing
during the pendency of an injunction. The public interest would
be disserved by an injunction whose operation would be to remove
the incentive for testing or actually to stop new testing. As for
harm to the parties, it is true that generic drug manufacturers
have something to lose and innovator drug manufacturers something
to gain from the denial of a preliminary injunction, but that
equation was set in place by the enactment of FDAMA.
The motion of American Academy of Pediatrics (AAP) to intervene
of right will be denied, although AAP claims an interest relating
to the "transaction which is the subject of the action,"
Fed.R.Civ.P. 24(a), and although AAP arguably has standing. AAP's
brief and oral argument were fully considered by the Court and
contributed to the Court's understanding of the public's interest
in providing incentives for pediatric studies of new drugs. But
AAP's interest is adequately represented by existing parties.