Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-12-05182/USCOURTS-caDC-12-05182-0/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

---

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. 

USCA Case #12-5182 Document #1424719 Filed: 03/12/2013 Page 1 of 6
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. 

USCA Case #12-5182 Document #1424719 Filed: 03/12/2013 Page 2 of 6
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).

USCA Case #12-5182 Document #1424719 Filed: 03/12/2013 Page 3 of 6
4

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,

USCA Case #12-5182 Document #1424719 Filed: 03/12/2013 Page 4 of 6
5

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

USCA Case #12-5182 Document #1424719 Filed: 03/12/2013 Page 5 of 6
6

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.

USCA Case #12-5182 Document #1424719 Filed: 03/12/2013 Page 6 of 6