Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-04-05238/USCOURTS-caDC-04-05238-0/pdf.json

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

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued March 17, 2005 Decided April 8, 2005

No. 04-5238

JEROME STEVENS PHARMACEUTICALS, INC.,

APPELLANT

v.

FOOD & DRUG ADMINISTRATION, ET AL.,

APPELLEES

Appeal from the United States District Court

for the District of Columbia

(No. 02cv01939)

Samuel H. Israel argued the cause for appellant. With him

on the briefs were John P. Halfpenny and Russell J. Gaspar.

Thomas M. Bondy, Attorney, U.S. Department of Justice,

argued the cause for appellees. With him on the brief were Peter

D. Keisler, Assistant Attorney General, Kenneth L. Wainstein,

U.S. Attorney, and Mark B. Stern, Attorney.

USCA Case #04-5238 Document #888103 Filed: 04/08/2005 Page 1 of 16
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Before: SENTELLE, HENDERSON and ROGERS, Circuit

Judges.

Opinion for the Court filed by Circuit Judge ROGERS.

ROGERS, Circuit Judge: The Food and Drug Administration

(“FDA”) posted on its website trade secrets and confidential

information contained in a New Drug Application (“NDA”) filed

by Jerome Stevens Pharmaceuticals, Inc. (“JSP”) for Unithroid,

a levothyroxine sodium (“LS”) drug used to treat thyroid

diseases. FDA also extended the NDA approval deadline,

allowing JSP’s competitors to continue marketing their

unapproved LS drugs for three years after Unithroid had been

approved. JSP filed a six-count complaint against FDA,

including two counts under the Federal Tort Claims Act

(“FTCA”), 28 U.S.C. §§ 2671-2680 (2000), for misappropriation

of trade secrets and breach of a confidential relationship, and one

count under the Administrative Procedure Act (“APA”), 5 U.S.C.

§ 706 (2000), for the arbitrary and capricious extension of the

NDA deadline. The district court dismissed the complaint for

lack of subject matter jurisdiction under Rule 12(b)(1) of the

Federal Rules of Civil Procedure, and JSP appeals the dismissal

of Counts I, II, and VI. We conclude that the district court

properly dismissed the APA claim in Count VI but erred as a

matter of law in ruling that the tort claims in Counts I and II were

barred by the discretionary function and intentional tort

exceptions to the FTCA. Accordingly, we affirm the dismissal

of Count VI, reverse the dismissal of Counts I and II, and

remand the case to the district court for further proceedings.

I.

The court reviews the district court’s dismissal of the

complaint de novo and “accept[s] all of the factual allegations in

[the] complaint as true.” Sloan v. U.S. Dep’t of Housing &

Urban Dev., 236 F.3d 756, 759 (D.C. Cir. 2001) (second

USCA Case #04-5238 Document #888103 Filed: 04/08/2005 Page 2 of 16
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alteration in original) (quoting United States v. Gaubert, 499

U.S. 315, 327 (1991)) (internal quotation marks omitted).

JSP is a small New York company that manufactures

Unithroid, an orally administered LS tablet used to treat thyroid

diseases. On August 14, 1997, FDA announced that, although

doctors had been prescribing LS tablets to millions of patients

since the 1950s, they were considered “new drugs” because “no

currently marketed orally administered levothyroxine sodium

product ha[d] been shown to demonstrate consistent potency and

stability.” 62 Fed. Reg. 43,535, 43,538 (Aug. 14, 1997).

Accordingly, FDA required LS manufacturers to submit NDAs

for FDA approval by August 14, 2000, and allowed the

continued marketing of unapproved LS tablets until that date.

See id. FDA stated that after the NDA deadline, any unapproved

orally administered LS drug would be “subject to regulatory

action.” Id.

On October 19, 1999, JSP filed an NDA for Unithroid.

Pursuant to FDA requirements, the NDA contained JSP’s “trade

secrets and confidential information for the manufacture of safe,

stable, and effective LS,” Compl. ¶ 28, including “[t]he order in

which Unithroid’s ingredients are added together; the steps that

the additions go through in the formation of Unithroid’s tablets;

and the processing of the active ingredient, levothyroxine

sodium,” id. ¶ 19. On April 26, 2000, FDA extended the August

14, 2000 approval deadline by one year to allow manufacturers

additional time to conduct studies and to prepare applications.

65 Fed. Reg. 24,488, 24,489 (Apr. 26, 2000).

On August 21, 2000, FDA approved Unithroid, making it

the first orally administered LS drug to be approved under the

new requirements. The next day, without JSP’s knowledge or

consent, FDA posted on its website JSP’s trade secrets and

confidential information for manufacturing Unithroid. On

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December 18, 2000, upon discovering FDA’s disclosure of its

trade secrets, JSP demanded that the information be removed

immediately from FDA’s website. After repeated requests, FDA

removed some of the information on January 12, 2001, and the

remaining information on January 23, 2001. Consequently,

JSP’s trade secrets were available to the public on FDA’s

website for five months.

Meanwhile, following FDA approval and anticipating

increased demand for Unithroid, JSP doubled its staff and

invested $2 million in expanding its facilities. On November 17,

2000, JSP filed a petition asking FDA not to extend the NDA

deadline a second time, asserting that it was prepared to supply

the entire market for LS drugs. Nonetheless, on July 13, 2001,

FDA announced that because “it will take time for the millions

of patients taking unapproved [LS] products to switch to

approved products, and for manufacturers of approved products

to scale up their production and to introduce this increased

production into the distribution chain,” manufacturers with

NDAs pending by August 14, 2001, could continue marketing

their unapproved LS tablets for an additional two years. 66 Fed.

Reg. 36,794, 36,794 (July 13, 2001). Following this

announcement, Abbott Laboratories “flooded the retail market”

with Synthroid, its unapproved LS tablet. Compl. ¶ 47. “Having

lost de facto market exclusivity due to FDA’s publication of its

secrets and FDA’s extensions of compliance deadlines,” JSP was

forced to lay off half its workforce and to destroy excess

Unithroid worth up to $30 million. Id. ¶ 48.

On October 2, 2002, JSP filed a six-count complaint against

FDA in the district court. Counts I and II alleged that, by

disclosing JSP’s trade secrets and confidential information, FDA

misappropriated JSP’s trade secrets and breached its confidential

relationship with JSP. Counts III and IV alleged that FDA’s

disclosure of JSP’s trade secrets violated procedural and

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substantive due process. Counts V and VI alleged that FDA’s

disclosure of JSP’s trade secrets and its extensions of the NDA

deadlines were arbitrary and capricious under the APA. The

complaint sought more than $1.3 billion in compensatory

damages “for [JSP’s] injuries resulting from [FDA’s]

misappropriation of [JSP’s] trade secrets and breach of FDA’s

confidential relationship with [JSP],” Compl. ¶ 118, and

declaratory relief for the remaining claims.

FDA filed a motion to dismiss for lack of subject matter

jurisdiction under Rule 12(b)(1), which the district court granted.

See Jerome Stevens Pharm., Inc. v. FDA, 319 F. Supp. 2d 45, 47

(D.D.C. 2004) (“JSP”). The district court construed Counts I

and II as alleging injuries caused solely by FDA’s extensions of

the NDA deadlines, and ruled that the tort claims in those counts

were barred by federal sovereign immunity because the deadline

extensions fell within both the discretionary function and

intentional tort exceptions to the FTCA. Id. at 50-52. The

district court ruled that Counts III, IV, and V failed to present a

live case or controversy because FDA had already removed

JSP’s trade secrets from its website. Id. at 52-54. Finally, the

district court ruled that Count VI was barred by the APA’s

presumption that agency enforcement actions are not subject to

judicial review. Id. at 54-57. JSP appeals the dismissal of

Counts I, II, and VI. 

II.

The FTCA “grants federal district courts jurisdiction over

claims arising from certain torts committed by federal employees

in the scope of their employment, and waives the government’s

sovereign immunity from such claims.” Sloan, 236 F.3d at 759;

see 28 U.S.C. §§ 1346(b), 2674 (2000). The grant of jurisdiction

and waiver of sovereign immunity are subject to several

exceptions, including the discretionary function exception and

the intentional tort exception. See 28 U.S.C. § 2680. The

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discretionary function exception bars claims “based upon the

exercise or performance or the failure to exercise or perform a

discretionary function or duty on the part of a federal agency or

an employee of the Government, whether or not the discretion

involved be abused.” Id. § 2680(a). The intentional tort

exception bars “[a]ny claim arising out of assault, battery, false

imprisonment, false arrest, malicious prosecution, abuse of

process, libel, slander, misrepresentation, deceit, or interference

with contract rights.” Id. § 2680(h).

To determine whether the discretionary function exception

applies, the court must engage in a two-part inquiry. Gaubert,

499 U.S. at 322-23; Macharia v.United States, 334 F.3d 61, 65

(D.C. Cir. 2003). First, the court must determine whether the

challenged action involves “an element of judgment or choice,”

or whether federal law “specifically prescribes a course of action

for an employee to follow,” leaving the employee “no rightful

option but to adhere to the directive.” Gaubert, 499 U.S. at 322

(quoting Berkovitz v. United States, 486 U.S. 531, 536 (1988))

(internal quotation marks omitted); Macharia, 334 F.3d at 65.

Second, the court must determine whether the challenged action

is “of the kind that the discretionary function exception was

designed to shield” — that is, actions “based on considerations

of public policy.” Gaubert, 499 U.S. at 322-23 (quoting

Berkovitz, 486 U.S. at 536, 537) (internal quotation marks

omitted); Macharia, 334 F.3d at 65.

JSP’s complaint challenges both FDA’s disclosure of JSP’s

trade secrets and FDA’s extensions of the NDA deadlines in

favor of JSP’s competitors. The parties appear to agree that the

disclosure of trade secrets is not a discretionary function because

federal laws prohibit it. See Br. of Appellant at 27 (citing 18

U.S.C. § 1905 (2000); 21 U.S.C. § 331(j) (2000); 5 U.S.C. §

552(b)(4) (2000); 21 C.F.R. § 314.430 (2004)); Br. of Appellee

at 18-23. The parties also appear to agree that the extension of

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the NDA deadline is a discretionary function because it involves

an element of choice and is based on considerations of public

health. See Br. of Appellant at 31-32; Br. of Appellee at 17-20;

Reply Br. of Appellant at 4-10. Thus, the only issue in dispute

is whether JSP’s tort claims are “based upon” the disclosure of

trade secrets or the extensions of the NDA deadlines.

In dismissing Counts I and II for lack of subject matter

jurisdiction, the district court interpreted those counts as alleging

injuries arising from FDA’s extensions of the NDA deadlines

rather than from FDA’s disclosure of JSP’s trade secrets. See

JSP, 319 F. Supp. 2d at 51. Based on this interpretation, the

district court ruled that JSP’s tort claims were barred by the

discretionary function exception because “extending the

deadlines clearly involves ‘an element of judgment or choice’”

and is based on “public-policy considerations regarding the

health needs of the millions of thyroid patients.” Id. at 52

(quoting Macharia, 334 F.3d at 65). The district court also

stated in a footnote that “[t]he intentional-torts exception also

appears to bar the tort claims, as the claims arguably ‘arise out

of’ [FDA’s] alleged interference with the contract rights and

prospective economic advantage of [JSP] and its partner, Watson

Laboratories.” Id. at 52 n.9; see also id. at 50 (citing 28 U.S.C.

§ 2680(h); Art Metal-U.S.A., Inc. v. United States, 753 F.2d

1151, 1155 (D.C. Cir. 1985)).

The district court based its interpretation of Counts I and II

on the economic loss report that JSP submitted as part of its

administrative claim for damages. See JSP, 319 F. Supp. 2d at

50-51 & n.7. The report explains the basis for JSP’s claim for

$1.3 billion in compensatory damages, relying on the assumption

that JSP and Jones Pharma — the only other LS manufacturer to

meet the August 14, 2001 deadline — “would have split 90% of

the market between them.” Id. at 50-51 (quoting Mem. in

Support of the United States’ Mot. to Dismiss, Attach. 1 at 1).

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This outcome was possible, the district court noted, “only if FDA

had not extended the August 2001 deadline to allow other LS

manufacturers to remain in the market.” Id. at 51. The district

court thus concluded that “the action causing [JSP’s] injury was

not the disclosure, but rather the deadline extensions (and more

specifically, the July 2001 extension).” Id. JSP points out,

however, that the report was not submitted as part of the

complaint but was instead attached to FDA’s motion to dismiss.

Although the complaint sought the same amount of damages as

the amount analyzed in the economic loss report, JSP maintains

that it is not barred from relying on “other expert reports or

damages evidence at trial to prove the claims in Counts I and II.”

Br. of Appellant at 32 n.8. For the following reasons, we hold

that the district court erred as a matter of law in concluding that

the complaint failed to allege an independent injury caused by

FDA’s disclosure of JSP’s trade secrets.

A.

At the pleading stage, the issue before the district court was

not whether JSP had established sufficient proof of damages

caused by FDA’s disclosure of JSP’s trade secrets, but whether

JSP had sufficiently pled claims for such damages. Cf. Scheuer

v. Rhodes, 416 U.S. 232, 236 (1974). While the district court

may consider materials outside the pleadings in deciding whether

to grant a motion to dismiss for lack of jurisdiction, see Herbert

v. Nat’l Acad. of Sciences, 974 F.2d 192, 197 (D.C. Cir. 1992),

the court must still “accept all of the factual allegations in [the]

complaint as true,” Gaubert, 499 U.S. at 327 (quoting Berkovitz,

486 U.S. at 540) (internal quotation marks omitted). Count I of

the complaint alleged that JSP’s NDA for Unithroid contained

trade secrets and confidential information; that FDA disclosed

such information on its website; and that “FDA’s disclosure of

[JSP’s] trade secrets and confidences has caused [JSP]

substantial and irreparable injury.” Compl. ¶ 75. Count II

alleged that FDA had a legal duty to maintain the confidentiality

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of proprietary information contained in JSP’s NDA; that FDA

breached that duty by posting JSP’s information on its website;

and that “FDA’s disclosure of [JSP’s] confidential information

for Unithroid has caused [JSP] to lose protection for its property

interest in the confidences unlawfully disclosed and has thus

caused [JSP] to suffer substantial and irreparable injury.”

Compl. ¶ 85. These allegations sufficiently pled claims for

damages caused by FDA’s disclosure of JSP’s trade secrets and

confidential information.

In treating Counts I and II as claims arising from FDA’s

extensions of the NDA deadlines, the district court relied on

JSP’s statement that it “lost de facto market exclusivity due to

FDA’s publication of its secrets and FDA’s extension of

compliance deadlines.” JSP, 319 F. Supp. 2d at 51 (quoting

Compl. ¶ 48) (emphasis added by the district court). From this

statement the district court concluded that JSP “does not ‘allege

some harm arising from [the disclosure] that was separate from

[the deadline extensions],’ and thus any harm from the disclosure

is not ‘sufficiently separable’ from the deadline extensions to

support suit under FTCA.” Id. at 51-52 (alterations in original)

(quoting Sloan, 236 F.3d at 762). Similarly, FDA contends that

JSP’s challenges to the disclosure of its trade secrets “are

intertwined with its broader challenge to the extension of the

agency’s deadlines.” Br. of Appellee at 14. FDA observes that

it examined the NDAs filed by JSP’s competitors and found that

“none of them used or relied upon [JSP’s] information in any

way.” Id. However, this observation is irrelevant, for the only

question at the pleading stage is whether JSP sufficiently alleged

an injury caused by FDA’s disclosure of its trade secrets. JSP’s

complaint specifically alleged that JSP suffered “substantial and

irreparable injury” arising from FDA’s disclosure of its trade

secrets and confidential information, Compl. ¶¶ 75, 85, and

sought more than $1.3 billion “for [JSP’s] injuries resulting from

[FDA’s] misappropriation of [JSP’s] trade secrets and breach of

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FDA’s confidential relationship with [JSP],” id. ¶ 118. Indeed,

the complaint sought only declaratory relief, not damages, for

JSP’s injuries resulting from FDA’s extensions of the NDA

deadlines.

In construing JSP’s tort claims as arising from FDA’s

deadline extensions, the district court cited two cases — Sloan

v. U.S. Department of Housing&Urban Development, 236 F.3d

756, 762 (D.C. Cir. 2001), and Fisher Bros. Sales, Inc. v. United

States, 46 F.3d 279, 286 (3d Cir. 1995) (en banc). See JSP, 319

F. Supp. 2d at 51. In Sloan, a contractor sued the Department of

Housing and Urban Development under the FTCA for

negligently conducting an audit of his construction site and for

suspending him from government contract work based on the

erroneous audit. 236 F.3d at 758-59. On appeal from the district

court’s dismissal of the complaint for lack of subject matter

jurisdiction, the contractor contended that while the suspension

of his government contract work was a discretionary function,

the audit was not a discretionary function because it was

governed by standards of professional practice. Id. at 761. The

court rejected that contention, holding that there was “no

meaningful way in which the allegedly negligent investigatory

acts could be considered apart from the totality of the

prosecution.” Id. (quoting Gray v. Bell, 712 F.2d 490, 516 (D.C.

Cir. 1983)) (internal quotation marks omitted). The court noted

that “[t]he complaint does not allege any damages arising from

the investigation itself, but only harm caused by the suspension

to which it assertedly led.” Id. at 762.

Similarly, in Fisher, Chilean fruit growers sued FDA under

the FTCA for banning the importation of Chilean fruit based on

a negligently conducted laboratory test concluding that the fruit

contained cyanide. 46 F.3d at 282-83. Recognizing that the

Commissioner’s decision to ban the fruit was a discretionary

function, the fruit growers alleged injury “based upon” the

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negligence of the laboratory technicians, who were bound by

FDA’s Regulatory Procedures Manual. Id. at 286. The Third

Circuit rejected this characterization of the claim, reasoning that

“[t]he reality here is that the injuries of which the plaintiffs

complain were caused by the Commissioner’s decisions and, as

a matter of law, their claims are therefore ‘based upon’ those

decisions.” Id. The court concluded that “a claim must be

‘based upon’ the exercise of a discretionary function whenever

the immediate cause of the plaintiff’s injury is a decision which

is susceptible of policy analysis and which is made by an official

legally authorized to make it.” Id. at 282 (emphasis added).

Here, unlike in Sloan and Fisher, the district court could not

conclude properly as a matter of law that none of JSP’s alleged

injuries were caused independently and immediately by FDA’s

disclosure of JSP’s trade secrets. Whereas the contractor in

Sloan did not allege injuries caused by the negligent audit, and

the negligent laboratory test in Fisher could not injure the fruit

growers unless the Commissioner relied on the test to ban the

fruit, JSP did allege injuries caused by the disclosure of its trade

secrets, and such disclosure could injure JSP even if FDA had

not extended the NDA deadlines. Thus, the district court erred

in treating JSP’s tort claims as “based upon” FDA’s deadline

extensions.

B.

The district court also recast Counts I and II as claims of

interference with contract rights. See JSP, 319 F. Supp. 2d at 50,

52 n.9. In so doing, the district court relied on Art Metal-U.S.A.,

Inc. v. United States, 753 F.2d 1151 (D.C. Cir. 1985), whichheld

that the intentional tort exception to the FTCA includes claims

of interference with prospective economic advantage. Id. at

1155. In Art Metal, the court treated a claim of interference with

prospective economic advantage as a claim of interference with

contract rights, which is barred by the intentional tort exception,

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because the duty underlying both claims is the same — namely,

the duty not to interfere with the plaintiff’s economic

relationship with a third party, whether or not that relationship is

secured by a contract. Id. at 1154. Here, the district court

treated JSP’s claims of misappropriation of trade secrets and

breach of a confidential relationship as a claim of interference

with contract rights, even though the duties underlying the claims

are different. The duty underlying the first set of claims is the

duty not to disclose trade secrets and confidential information

contained in JSP’s NDA, whereas the duty underlying the second

claim is the duty not to interfere with JSP’s economic

relationship with a third party, namely its business partner

Watson Laboratories. See JSP, 319 F.2d at 52 n.9. Thus, the

district court erred in treating Counts I and II of JSP’s complaint

as claims of interference with contract rights and dismissing

them as barred by the intentional tort exception.

While FDA points to portions of the complaint

characterizing the disclosure of JSP’s trade secrets as

“deliberate,” Br. of Appellee at 25 (citing Compl. ¶ 95), the

complaint also alleges that FDA believed the disclosure to be an

“accident,” Compl. ¶ 46. But whether the disclosure was

intentional or negligent does not determine whether the

intentional tort exception applies, for the FTCA expressly states

the claims that the exception bars, and it does not include

misappropriation of trade secrets or breach of confidentiality.

See 28 U.S.C. § 2680(h). The court’s task is limited to

identifying “‘those circumstances which are within the words

and reason of the exception’ — no less and no more.” Kosak v.

United States, 465 U.S. 848, 853 n.9 (1984) (quoting Dalehite v.

United States, 346 U.S. 15, 31 (1953)).

The Second Circuit’s decision in Kramer v. U.S.

Department of the Army, 653 F.2d 726 (2d Cir. 1980), supports

JSP’s claim of error. In that case, a manufacturer of mortar

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projectiles sued the Army for wrongfully terminating her

contract, disclosing confidential information about her exclusive

supplier of forging blanks to a competing manufacturer, and then

awarding the contract to the competing manufacturer. 653 F.2d

at 728. While the pro se plaintiff labeled her claim as one of

“conversion,” the district court treated it as a claim of intentional

interference with contract rights, which it dismissed as barred by

the intentional tort exception to the FTCA. Id. at 729. The

Second Circuit reversed, holding that the plaintiff’s “putative

‘conversion’ claim must be viewed as a cause of action for

misappropriation of a trade secret recognized under New York

law and consequently within the district court’s jurisdiction

under the Federal Tort Claims Act.” Id. The court explained

that, “[s]tripped to their essentials, [the plaintiff’s] factual

allegations reduce to this: the Government induced [the plaintiff]

to disclose the identity of her supplier in confidence, and then

divulged that information to others in breach of that confidence.”

Id. The court concluded that the complaint stated a claim for

misappropriation of trade secrets, not a claim for interference

with contract rights. Id.

Counts I and II of JSP’s complaint, “stripped to their

essentials,” reduce to this: FDA induced JSP to disclose its trade

secrets in confidence, and then it divulged that information to

others in breach of that confidence. Thus, JSP’s complaint

sufficiently alleges claims for misappropriation of trade secrets

and breach of a confidential relationship. FDA’s only response

is that “whether the plaintiff’s claims were potentially barred as

arising out of ‘interference with contract rights’ . . . was neither

raised nor addressed in Kramer.” Br. of Appellee at 28. FDA is

mistaken, however, because the Second Circuit reversed the

district court’s dismissal of the complaint on this very basis.

Counts I and II therefore must be reinstated.

III.

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Under the APA, a reviewing court must set aside an agency

action that is “arbitrary, capricious, an abuse of discretion, or

otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A).

A court may not review an agency action, however, if the

“agency action is committed to agency discretion by law.” Id. §

701(a)(2). In Heckler v. Chaney, 470 U.S. 821 (1985), the

Supreme Court held that “an agency’s decision not to prosecute

or enforce, whether through civil or criminal process, is a

decision generally committed to an agency’s absolute discretion”

and therefore is presumptively unreviewable. Id. at 831. This

presumption of unreviewability may be overcome “where the

substantive statute has provided guidelines for the agency to

follow in exercising its enforcement powers,” or “where the

agency has conspicuously and expressly adopted a general policy

that is so extreme as to amount to an abdication of its statutory

responsibilities.” Baltimore Gas & Elec. Co. v. FERC, 252 F.3d

456, 460 (D.C. Cir. 2001) (quoting Chaney, 470 U.S. at 833 &

n.4) (internal quotation marks omitted).

In dismissing Count VI of JSP’s complaint, the district court

ruled that FDA’s extensions of the NDA deadlines “qualify as

decisions not to prosecute or enforce, and therefore enjoy a

presumption of unreviewability.” JSP, 319 F. Supp. 2d at 56. It

explained that FDA had announced in its August 14, 1997 notice

that unapproved LS drugs would “be subject to regulatory

action” after August 14, 2000, id. (quoting 62 Fed. Reg. at

43,538), and that FDA’s subsequent deadline extensions

constituted exercises of its enforcement discretion based on “a

balancing of factors that clearly fall within FDA’s expertise, such

as the medical necessity of LS drugs and the period of time

needed to transition millions of patients safely from an

unapproved- to an approved-drug system,” id.; see 65 Fed. Reg.

at 24,489; 66 Fed. Reg. at 36,794. The district court then

examined 21 U.S.C. § 355 and 21 U.S.C. § 393, which JSP

claimed to provide guidance for FDA’s exercise of enforcement

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discretion, and concluded that neither provision “provides

enforcement guidelines sufficient to overcome the presumption

of unreviewability.” JSP, 319 F. Supp. 2d at 56 (citing Chaney,

470 U.S. at 832-33). The district court noted that the Supreme

Court held in Chaney that 21 U.S.C. § 355, which prohibits the

introduction of unapproved new drugs into the market and

describes the NDA approval process, is “simply irrelevant to the

agency’s discretion to refuse to initiate [enforcement]

proceedings.” Id. (alteration in original) (quoting Chaney, 470

U.S. at 836) (internal quotation marks omitted). The district

court also concluded that 21 U.S.C. § 393, which sets forth

FDA’s mission statement, “does not address enforcement . . . and

if anything only underscores FDA’s authority to determine how

best to ensure the safety and effectiveness of drugs.” Id. at 56-57

(citing Safe Energy Coalition v. Nuclear Regulatory Comm’n,

866 F.2d 1473, 1478 (D.C. Cir. 1989)). Finally, the district court

ruled that FDA’s deadline extensions did not amount to “an

abdication of its statutory responsibilities” because the

extensions did not “constitute a permanent policy for all existing

new drug products . . . but rather were limited to non-approved

manufacturers for a period of three years.” Id. at 57 (citing Shell

Oil Co. v. EPA, 950 F.2d 741, 765 (D.C. Cir. 1991)).

JSP does not dispute any of the district court’s legal

conclusions. Rather, it contends that the district court focused

“too narrowly” on its challenge to FDA’s deadline extensions

and ignored its broader challenge to “FDA’s entire course of

conduct in the LS drug program going back to the August 1997

Notice.” Br. of Appellant at 37. Count VI of the complaint

alleged that FDA “acted arbitrarily, capriciously, and in violation

of 21 U.S.C. §§ 355; 393” when it (1) extended its August 14,

2000 approval deadline to August 14, 2001, Compl. ¶ 112; (2)

changed its August 14, 2001 approval deadline to a filing

deadline and allowed manufacturers with pending NDAs to

continue marketing unapproved LS drugs until August 14, 2003,

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Compl. ¶ 113; (3) “departed from consistent and longstanding

precedent” by allowing manufacturers to continue marketing

unapproved LS drugs for three years after Unithroid’s approval,

Compl. ¶ 115; and (4) took “inconsistent positions” by finding

unapproved LS drugs to be unstable and unsafe and yet

permitting unapproved LS drugs to be marketed for three years

after Unithroid’s approval, Compl. ¶ 117. These allegations

essentially challenge three FDA actions: (1) extension of the

August 14, 2000 deadline to August 14, 2001; (2) conversion of

the August 14, 2001 approval deadline into a filing deadline; and

(3) authorization of manufacturers with pending NDAs to

continue marketing unapproved LS drugs until August 14, 2003.

Each of these actions is an exercise of FDA’s enforcement

discretion, and JSP fails to demonstrate how 21 U.S.C. § 355 and

21 U.S.C. § 393 provide guidelines for the exercise of such

discretion. To the extent JSP also contends that the district court

should have allowed it to amend its complaint, JSP did not seek

to amend its complaint and thus cannot show error by the district

court for failing to afford unrequested relief. See United States

ex rel. Totten v.Bombardier Corp., 286 F.3d 542, 552-53 (D.C.

Cir. 2002).

Accordingly, we affirm the dismissal of Count VI, reverse

the dismissal of Counts I and II of JSP’s complaint, and remand

the case to the district court for further proceedings.

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