Hill Dermaceuticals, Inc. v. Food & Drug Administration

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued February 22, 2013 Decided March 12, 2013
No. 12-5182
HILL DERMACEUTICALS, INC.,
APPELLANT
v.
FOOD & DRUG ADMINISTRATION, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:11-cv-01950)
Larry M. Roth argued the cause for appellant. With him on
the brief was Neil P. Di Spirito.
Cindy J. Cho, Attorney, U.S. Department of Justice, argued
the cause for appellees. With her on the brief were Stuart F.
Delery, Principal Deputy Assistant Attorney General, Maame
Ewusi-Mensah Frimpong, Deputy Assistant Attorney General,
and Drake Cutini, Attorney.
William D. Coston, Martin L. Saad, and David D. Conway
were on the brief for intervenor Amneal Pharmaceuticals, LLC
in support of appellee.
2
Before: BROWN, Circuit Judge, and EDWARDS and
SILBERMAN, Senior Circuit Judges.
Opinion for the Court filed PER CURIAM.
PER CURIAM: Hill Dermaceuticals filed a successful new
drug application with the FDA in 1988 for a corticosteroid
called “Derma-Smoothe.” The application included three
separate products — body oil, scalp oil, and ear oil drops. In
2011 the FDA approved three abbreviated new drug applications
(“ANDAs”) submitted by Identi Pharmaceuticals for generic
versions of Hill’s three products. Hill sued the FDA in the U.S.
District Court for the District of Columbia, arguing that the
FDA’s approval of Identi’s products was arbitrary and
capricious under the Administrative Procedure Act.1 The district
court granted summary judgment to the FDA, and Hill filed this
appeal.
Under the Hatch-Waxman Amendments to the Food, Drug,
and Cosmetic Act, abbreviated drug applications need not
include all of the same clinical data as new drug applications.
1
Before the district court, Hill sought both declaratory and
injunctive relief, seeking to enjoin the FDA from approving Identi’s
new drugs — which apparently is a common kind of request in these
cases. Usually, where a district court reviews agency action under the
APA, it acts as an appellate tribunal, so the appropriate remedy for a
violation is “simply to identify a legal error and then remand to the
agency.” Bennett v. Donovan, 703 F.3d 582, 589 (D.C. Cir. 2013)
(quoting N. Air. Cargo v. U.S. Postal Serv., 674 F.3d 852, 861 (D.C.
Cir. 2012)). But because preliminary injunctions are expedited, they
may sometimes be appropriate in APA cases where time is of the
essence — for instance, where a party believes there is an immediate
need to prevent a new drug from reaching the market. But any such
injunction would need to be limited only to vacating the unlawful
action, not precluding future agency decisionmaking.
3
Rather, ANDA applicants need only identify an approved drug
and then “show that the new drug is bioequivalent to the listed
drug.” 21 U.S.C. § 355(j)(2)(A)(iv).2 FDA regulations establish
that the requirement to submit data showing bioequivalence may
be waived where the drug is a solution for application to the
skin, has active ingredients in the same concentration and
dosage as an approved drug, and “[c]ontains no inactive
ingredient or other change in formulation from [an approved
drug] that may significantly affect absorption of the active drug
ingredient.” 21 C.F.R. § 320.22(b)(3). The FDA granted
bioequivalence waivers for Identi’s body and scalp oil under
§ 320.22(b)(3) and granted a waiver for Identi’s ear drops under
21 C.F.R. § 320.24(b)(6), a catch-all provision allowing waiver
under “[a]ny other approach deemed adequate by FDA to . . .
establish bioequivalence.”
As a preliminary matter, Hill argues that the district court
abused its discretion in refusing to consider 21 extra-record
declarations that purportedly provide detailed technical
information about Hill’s products. But of course, it is
black-letter administrative law that in an APA case, a reviewing
court “should have before it neither more nor less information
than did the agency when it made its decision.” Walter O.
Boswell Mem’l Hosp. v. Heckler, 749 F.2d 788, 792 (D.C. Cir.
1984). The district court did not abuse its discretion in adhering
to this well-established principle.
We have recognized a small class of cases where district
2
A drug is “bioequivalent” to a listed drug if “the rate and extent
of absorption of the drug do not show a significant difference from the
rate and extent of absorption of the listed drug when administered at
the same molar dose of the therapeutic ingredient under similar
experimental conditions in either a single dose or multiple doses.” 21
U.S.C. § 355(j)(8)(B)(i).
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courts may consult extra-record evidence when “the procedural
validity of the [agency]’s action . . . remains in serious
question,” Esch v. Yeutter, 876 F.2d 976, 991 (D.C. Cir. 1989),
but Hill’s case does not fall within this narrow set of exceptions.
Esch has been given a limited interpretation since it was
decided, and at most it may be invoked to challenge gross
procedural deficiencies — such as where the administrative
record itself is so deficient as to preclude effective review. See
Theodore Roosevelt Conservation P’ship v. Salazar, 616 F.3d
497, 514 (D.C. Cir. 2010).
Hill then presents four arguments challenging the FDA’s
decision to grant bioequivalence waivers, but none have merit.
First, appellant argues that its products are not “solutions” under
21 C.F.R. § 320.22(b)(3), so waiver was not allowed under this
provision. But the relevant question is whether the new drug,
not the listed drug, is a solution, and in any event, record
evidence amply supports the FDA’s conclusion that both
products are solutions (for example, the active ingredient in both
is dissolved in isopropyl alcohol).
Second, Hill suggests that the FDA improperly approved
Identi’s scalp oil because the agency had previously stated that
the scalp needed to be treated differently from other body skin
for the purposes of bioequivalence. But that statement made
clear that different testing for the scalp was needed only where
the requirements of a waiver were not met. Here, the FDA
reasonably determined that a waiver was warranted, so
appellant’s argument is beside the point.
Third, Hill argues that the waiver for Identi’s ear drops was
improper because Identi omitted two fragrances that Hill had
used in its own products. Though these fragrances are inactive
ingredients, Hill suggests that their absence would alter the
drug’s substantive effects. But this is the sort of technical,
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scientific question on which deference to agencies is especially
warranted. The FDA reasonably concluded — after examining
the makeup of Identi’s drugs and consulting with multiple
divisions within the agency — that the omission of the
fragrances would have no expected effect on efficacy or safety.
And fourth, appellant contends that the FDA’s approval of
Identi’s abbreviated applications contained sufficiently
numerous and serious inaccuracies to render these decisions
arbitrary and capricious. But most of these alleged errors are
minor technical mistakes, such as the use of a wrong application
number for an Identi product or listing an incorrect date on a
prior application, and Hill develops no argument suggesting that
the alleged errors resulted in prejudicial treatment or that the
agency’s ultimate decision would have been any different but
for these inaccuracies.
Finally, Hill argues that the FDA should not have approved
Identi’s drugs because Identi does not use the same labeling as
Hill. Specifically, the current labeling for Hill’s products states:
“The peanut oil used in Derma-Smoothe/FS is tested for peanut
proteins through amino acid analysis which can detect the
quantity of amino acids to below 0.5 parts per million.” Identi,
by contrast, states merely that its products include peanut oil
refined under U.S. Pharmacopeia-National Formulary
(“USP-NF”) standards. Appellant suggests that this difference
violates the same-labeling provision in 21 U.S.C.
§ 355(j)(2)(A)(v), which requires ANDA applicants to “show
that the labeling proposed for the new drug is the same as the
labeling approved for the listed drug . . . except for changes
required . . . because the new drug and the listed drug are
produced or distributed by different manufacturers.”
The key phrase in the statute is “labeling approved for the
listed drug.” The FDA has concluded that Hill’s amino-acid
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testing method has not been validated and has thus instructed to
Hill to remove this line from its labels. The agency has instead
decided that the use of peanut oil refined according to USP-NF
standards (basically, heat to 475°F for 15 minutes) is sufficient
to reduce peanut proteins to safe levels. Hill’s label is not
“approved” for the listed drug, so Identi need not copy Hill’s
statement about a non-validated method. Moreover, 21 C.F.R.
§ 314.94(a)(8)(iv), the regulation implementing this labeling
requirement, specifically states that the different-manufacturers
exception “may include . . . labeling revisions made to comply
with current FDA labeling guidelines or other guidance.”
Hill’s briefing makes a number of hyperbolic references to
the “immutable laws of science,” but the basic tenets of
administrative law have greater impact on our decisions. The
FDA’s actions were not arbitrary and capricious, and the district
court’s grant of summary judgment is affirmed.
So ordered.