Appendix — CareToLive v. von von Eschenenbach (No. 08-584)

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APPENDIX A

NOT RECOMMENDED FOR FULL-TEXT

PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

Case No. 07-4465

[Filed August 28, 2008]

CARETOLIVE,

Plaintiff-Appellant,

Vv.

ANDREW VON ESCHENBACH,

Commissioner, Food and Drug

Administration, et al.,

Defendants-Appellees.

ee ee ee ee ee ee ee ee ee

ON APPEAL FROM THE UNITED STATES

DISTRICT COURT FOR THE SOUTHERN

DISTRICT OF OHIO

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BEFORE: BATCHELDER and GILMAN, Circuit

Judges; ZOUHARY '’, District Judge.

ALICE M. BATCHELDER, Circuit Judge.

Plaintiff—Appellant CareToLive (“CTL”), appeals the

judgment of the district court dismissing CTL’s action

for lack of subject matter jurisdiction. CTL, which

characterizes itself as an association of cancer

patients, patient families, doctors, investors, and

advocates, filed suit in the district court to challenge

the Food and Drug Administration’s (“FDA”) decision

not to immediately approve a Biologics License

Application (“BLA”) for the vaccine Provenge. The

FDA neither approved nor denied the application, but

instead issued a Complete Response Letter to the

vaccine’s sponsor, Dendreon Corp., requesting more

information. CTL’s lawsuit named as defendants the

Commissioner ofthe FDA, Andrew von Eschenbach,

M.D., and the Secretary of the United States

Department of Health and Human Services, Michael

Leavitt, in their official capacities; the complaint also

named two FDA officials, Richard Pazdur, M.D., and

Howard Scher, M.D., in both their official and

individual capacities.

On November 21, 2007, the district court dismissed

CTL’s official-capacity claims for lack of subject matter

jurisdiction, citing ripeness, finality, and sovercign

immunity. CTL filed an immediate notice of appeal.

On December 4, 2007, the district court dismissed

CTL’s individual-capacity claims. CTL filed no notice

' The Honorable Jack Zouhary, U.S. District Judge for the

Northern District of Ohio, sitting by designation.

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of appeal from the latter order, and appeals only the

dismissal of its official-capacity claims.

After carefully reviewing the record, the applicable

law, the parties’ briefs and counsels’ arguments, we

conclude that the district court did not err in its

conclusion that it lacked subject matter jurisdiction

because, at the very least, CTL’s action is unripe. As

the district court’s opinion carefully and correctly sets

out the law governing the issues raised, and clearly

articulates the reasons underlying its decision,

issuance of a full written opinion by this court would

serve no useful purpose. Accordingly, for the reasons

stated in the district court’s opinion dismissing CTL’s

official-capacity claims, we AFFIRM.

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APPENDIX B

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF OHIO

EASTERN DIVISION

Case No. 2:07-cv-729

[Filed November 21, 2007;

CARETOLIVE,

Plaintiff,

v.

ANDREW von ESCHENBACH, et al.,

Defendants.

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JUDGE GREGORY L. FROST

Magistrate Judge Norah McCann King

OPINION AND ORDER

This action involves a biologics license application

(“BLA”) that ‘was submitted to the Food and Drug

Administration (“FDA”) for Provenge, a biological

product which is intended to treat a particular type of

metastatic prostate cancer and is manufactured by

Dendreon Corporation. Plaintiff CareToLive

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challenges the decision of the FDA “not to approve

Provenge for immediate use and instead [to] issue[] a

Complete Response Letter requesting more data.”

(Doc. # 22.) This matter is before the Court on

Defendants’ Motion to Dismiss Plaintiffs Official

Capacity Claims (Doc. # 38) and on Defendants’

Motion to Strike Improper Supplemental

Memorandum (Doc. # 59). For the reasons that follow,

the Court GRANTS both of Defendants’ motions.

I. BACKGROUND

A. The Parties

Plaintiff characteriz :s itself as an association of

“cancer patients, patient families, doctors, investors,

and advocates.” (Doc. # 22 at 2.) Plaintiff brought this

action against the Commissioner of the FDA Andrew

von Eschenbach, M.D., and the Secretary of the United

States Department of Health and Human Services

Michael Leavitt, in their official capacities and against

Richard Pazdur, M.D. and Howard Scher, M.D., in

both their official and individual capacities.’ Id. ]] 4,

5, 6, 7. Pazdur is the Director of the Office of

Oncologic Drug Products in the FDA’s Center for Drug

Evaluation and Research. Id. { 6. Scher is a special

government employee who served on the FDA

Advisory Committee that considered the Provenge

BLA. Id. ¥ 7.

' Defendants filed a separate motion to dismiss the claims against

Pazdur and Scher (Doc. # 37). The Court addresses arguments for

dismissal of the personal capacity claims set forth in that motion

by separate Opinion and Order.

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B. Statutory and Regulatory Scheme

Biological products are defined under the Public

Health Service Act (“PHSA”) as any “virus, therapeutic

serum, toxin, antitoxin, vaccine . . . or analogous

product .. . applicable to the prevention, treatment, or

cure of a disease or condition of human beings.” 42

U.S.C. § 262(i). Biological products can also be drugs,

and are generally subject to the same statutory and

regulatory requirements that apply to drugs. See 42

U.S.C. § 262(j) (the Food, Drug, and Cosmetic Act

(“FDCA”), 21 U.S.C. § 321, applies to biological

products subject to regulation under the PHSA, 42

U.S.C. § 262).

The FDCA defines “drug” to include, inter alia,

“articles intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in man

....” 21U.S.C. § 321(g)(1)(B). A “new drug” is defined

as either (1) a drug that is “not generally recognized,

among experts qualified by scientific training and

experience to evaluate the safety and effectiveness of

drugs, as safe and effective for use under the

conditions prescribed, recommended, or suggested in

the labeling thereof,” or (2) a drug that, “as a result of

investigations to determine its safety and effectiveness

for use under such conditions, has become _ so

recognized, but which has not, otherwise than in such

investigations, been used to a material extent or for a

material time under such conditions.” 21 U.S.C.

§ 321(p).

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1. Biological Product Approval Process

For unapproved biological products, the sponsor

seeks FDA approval by submitting a BLA pursuant to

the PHSA. 42 U.S.C. § 262(a). The FDA will approve

a BLA for an unapproved biological product if the BLA

demonstrates that the product is safe, pure, and

potent, id. § 262(a)(2)(C)(G)(1), and that the facility in

which the product is manufactured “meets standards

designed to assure that the biological product

continues to be safe, pure, and potent,” id.

§ 262(aM2 CIID.

Generally, when the sponsor of a biological product

has completed the clinical trial process, it can submit

a BLA in accordance with 21 C.F.R. § 601.2(a). The

required documentation in a BLA provides information

for the FDA evaluation of the biological product,

including the results of clinical trials, the composition

of the drug, manufacturing information, and sample

labeling. Jd. The FDA will not consider a BLA to be

filed until all pertinent data have been received by the

agency. See id.

2. FDA Responses to a BLA

In response to a BLA, the FDA may refuse to file it

if it is incomplete. See FDA, “Refusal to File Procedure

for Biologics License Applications,” SOPP 8404,

available at http://www.fda.gov/cber/regsopp/

8404.htm. Further, under certain circumstances the

FDA will approve a BLA, 21 C.F.R. § 601.4(a), or deny

it and provide the applicant the opportunity for a

hearing, id. § 601.4(b). Finally, if there are

deficiencies in the BLA, the FDA may send a Complete

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Response Letter declining to approve the BLA as it

was presented and requesting additional information

from the sponsor. Applications for Approval to Market

a New Drug, 69 Fed. Reg. 43351, 43352 (July 20, 2004)

(to be codified at 21 C.F.R. §§ 314.110, 314.120).

C. Statement of Facts

Provenge is a biological product intended to treat a

particular type of metastatic prostate cancer. (Doc. #

22 4 15.) Provenge uses a patient’s own cells to

prepare a final product designed for infusion back into

the patient’s bloodstream to activate his or her

immune system against the cancer cells. Jd. {J 14, 16.

Provenge is referred to as an active cellular

immunotherapy, designed to elicit a patient’s specific |

immune response to a target antigen expressed in

prostate cancer tissue, i.e., to train a patient’s immune

system to recognize cancer cells and to fight them. Id.

4% 14-16, 19. Because it is designed to act in this

manner, Provenge is a vaccine and thus a “biological

product” subject to FDA regulation under the PHSA.

42 U.S.C. § 262(i).

Dendreon has been studying Provenge’s safety and

effectiveness in clinical trials pursuant to an

investigational new drug application it submitted to

the FDA in 1996. See Transcript of March 29, 2007

Cellular, Tissue, and Gene Therapies Advisory

Committee Meeting at 20; (Doc. # 23, Ex. C.)

Dendreon submitted its BLA for Provenge in late 2006,

and the FDA considered it to be filed in January 2007.

(Doc. # 22 Y 27.) Because Provenge is an

immunotherapy vaccine, regulatory responsibility for

reviewing and, ultimately, approving or denying

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approval of the BLA rests with the Office of Cellular,

Tissue, and Gene Therapies in the FDA Center for

Biologics Research and Evaluation (“CBER”). Id. 4 29;

68 Fed. Reg. 38067, 38068 (June 26, 2003).

In the Amended Complaint, Plaintiff claims that

Pazdur intentionally violated “Federal Regulations

and US Law by improperly controlling the makeup of

the FDA [Office of Cellular, Tissue, and Gene

Therapies] Advisory Committee, and applying

improper pressure on Committee members” in an

effort to deny due process for the BLA for Provenge;

purposely placed on the Advisory Committee two

oncologists who had conflicts of interest and who

Pazdur was sure would be opposed to the approval of

Provenge; prior to the vote, changed the question

posed to the Advisory Committee members to get them

to recommend against approval of Provenge; and

“recruited and illegally used [the] FDA employees” at

and after the Advisory Committee meeting to assist

Pazdur in “wrecking” the Provenge BLA by requesting

anti-Provenge letters and “design[ing] a method for

‘leaking’ them to the press.” (Doc. # 22 79 6, 50, 62,

63, 67, 70, 71, 72, 73, 77, 79.)

Further, Plaintiff alleges that Scher “failled] to

disclose conflicts of interest that would have placed the

FDA on notice that his own personal interests

provided him additional reasons” to be opposed to the

immediate approval of the Provenge BLA; wrote a

letter attacking Provenge that contained false

information and that was later “leaked to the press”;

and failed to exercise care in the responsibility he

undertook to aid patients. Jd. J{ 7,60, 70, 72, 77, 79.

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Plaintiff also alleges Leavitt, who controls that

agency with FDA oversight duties, “ignored and

continues to ignore the agency’s dysfunction.” Id. 4 5.

Finally, Plaintiff claims that von Eschenbach “decided

not to approve Provenge for immediate use and instead

issued a Complete Response Letter requesting more

data which might not be available until 2010.” Zd.

q 43.

On May 8, 2007, CBER issued a Complete

Response Letter to Dendreon, Provenge’s sponsor,

declining to approve the BLA in its current form

because of various deficiencies. See Dendreon Corp.,

“Dendreon Receives Complete Response Letter from

FDA for Provenge Biologics License Application,” May

9, 2007, available at http://investor.dendreon.com/

Release Detail.cfm?ReleaseID=241649&Header=News

(“Dendreon Receives Complete Response Letter”). The

FDA requested that Dendreon submit additional

information with respect to the chemistry,

manufacturing, and controls section of the BLA, id.;

such information is required to demonstrate that the

facility in which the product would be manufactured

“meets standards designed to assure that the biological

product continues to be safe, pure, and potent.” 42

U.S.C. § 262(aK2KCXiXID. The FDA also requested

that Dendreon submit additional clinical data in

support of its effectiveness claim. Dendreon Receives

Complete Response Letter. Dendreon has since met

with the FDA to discuss the additional data required

to support licensure and indicated that it intends to

proceed with its new Phase 3 study designed to

measure survival and to submit such data to the FDA

when it becomes available. See Dendreon Corp.,

“Dendreon Announces FDA Confirms Data Required

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for Provenge Licensure,” May 31, 2007, available at

http:/Anvestor.dendreon.com/ReleaseDetail.cfm?Rele

aseID=246500 &Header=News.

Plaintiff submitted a citizen petition to the FDA

dated July 26, 2007. (Doc. # 2 Ex. B.) The FDA’s

Docket Branch received the citizen petition on July 27,

2007 and assigned it docket number 2007P-0297. Jd.

Under FDA regulations, a citizen petition is the

mechanism for formally asking the agency to take a

particular action, and is a prerequisite to filing suit on

the subject. See 21 C.F.R. §§ 10.25, 10.30, 10.45. In its

citizen petition, Plaintiff urges the Commissioner of

Food and Drugs to “reverse [the FDA’s] decision to

deny immediate approval to Provenge.” (Doc. # 2 Ex.

B.) FDA regulations require the Commissioner, within

180 days of receipt of a citizen petition, to either

approve the petition, deny the petition, or, if more time

is required, issue a tentative response. 21 C.F.R.

§ 10.30(e)(2). On July 30, 2007, the FDA

acknowledged receipt of the citizen petition, but

otherwise has not yet responded. See 7/30/07 Letter.,

Jaffe to Kearney, available at

http://www. fda.gov/ohrms/dockets/dockets/07 p0297/

07p-0297-ack000 1-vol1.pdf.

On July 30, 2007, Plaintiff filed this action and on

September 5, 2007, Plaintiff filed an amended

complaint (Doc. # 22).

On October 5, 2007, Defendants Pazdur and Scher

filed their motion to dismiss (Doc. # 37) and on October

24, 2007, Plaintiff filed its memorandum in opposition

to that motion (Doc. # 46). Defendants filed their reply

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in support of their motion to dismiss on October 31,

2007. (Doc. # 51.)

On October 5, 2007, Defendants filed their motion

to dismiss the claims brought against them in their

official capacity. (Doc. # 38.) On October 19, 2007,

Plaintiff filed its memorandum in opposition to

Defendants’ motion (Doc. # 43) and on October 26,

2007, Defendants filed their reply in support of their

motion.

On November 11, 2007, Plaintiff filed Plaintiffs

Supplemental Memorandum in Support of

Memorandum in Opposition to Defendant’s Motion to

Dismiss and as Supplement to Motion for Injunctive

Relief. (Doc. #58.) Defendants filed a motion to strike

the supplemental memorandum on November 13,

2007. (Doc. # 59.)

II. MOTION TO STRIKE

Plaintiff filed a supplemental memorandum in

support of its memorandum in opposition to

Defendants’ motions to dismiss. (Doc. #58.) Plaintiff

contends that it has new evidence that this Court

should view in its consideration of Defendants’ motions

to dismiss.

Defendants move to strike Plaintiff's supplemental

memorandum pursuant to Rule 7.2 of the Southern

District of Ohio Civil Rules, which allows the party

opposing a motion to file an opposition brief; and the

party filing a motion to support it with an opening

brief and a reply brief. S.D. Ohio Civ. R. 7.2(a)(2). “No

additional memoranda beyond those enumerated will

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be permitted except upon leave of court for good-cause

shown.” Id. Plaintiff has neither requested leave of

Court to file its supplemental memorandum nor has it

shown the good cause necessary to comply with Rule

7.2. Moreover, Plaintiff failed to consult with

Defendants or to bring its allegedly new evidence to

the attention of the Court, both as required by

subsection (d) of Local Rule 7.2.

Consequently, the Court GRANTS Defendants’

Motion to Strike Improper Supplemental

Memorandum. (Doc. # 59.) However, the Court notes

that there is nothing in Plaintiffs supplemental

memorandum that would have changed this Court’s

analysis of Defendants’ motions to dismiss.

Ill, STANDARD FOR MOTION TO DISMISS

Defendants move to dismiss under, inter alia,

Rule12(b)(1) of the Federal Rules of Civil Procedure,

which provides for dismissal for “lack of subject matter

jurisdiction[.] Fed. R. Civ. P. 12(b)(1). “A Rule 12(b)(1)

motion can either attack the claim of jurisdiction on its

face, in which case all allegations of the plaintiff must

be considered as true, or it can attack the factual basis

for jurisdiction, in which case the trial court must

weigh the evidence and the plaintiff bears the burden

of proving that jurisdiction exists.” DLX, Inc. v.

Kentucky, 381 F.3d 511, 516 (6th Cir. 2004) (citing

RMI Titanium Co. v. Westinghouse Elec. Corp.,78 F.3d

1125, 1133-35 (6th Cir. 1996)). In this action, all

parties have submitted evidence in support of their

positions on dismissal and all parties point to disputed

facts that they have called upon the Court to resolve.

(Doc. ## 37, 38, 43, 46, 47, 51.) Thus, Defendants

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mount a factual attack on the jurisdiction of this

Court. The United States Court of Appeals for the

Sixth Circuit instructs that,

when a court reviews a complaint under a

factual attack, as here, no presumptive

truthfulness applies to the factual allegations.

Such a factual attack on subject matter

jurisdiction commonly has been referred to as a

“speaking motion.” See generally C. Wright &

A. Miller, Federal Practice and Procedure

§ 1364, at 662-64 (West 1969). When facts

presented to the district court give rise to a

factual controversy, the district court must

therefore weigh the conflicting evidence to

arrive at the factual predicate that subject

matter jurisdiction exists or does not exist. In

reviewing these speaking motions, a trial court

has wide discretion to allow affidavits,

documents and even a limited evidentiary

hearing to resolve disputed jurisdictional facts.

(citations omitted.)

Ohio Nat'l Life Ins. Co. v. United States, 922 F.2d 320,

325 (6th Cir. 1990); see also Nat'l Assoc. of Minority

Contractors v. Martinez, 248 F. Supp.2d 679, 681 (S.D.

Ohio 2002) (applying foregoing standard).

IV. MOTION TO DISMISS OFFICIAL

CAPACITY CLAIMS

Plaintiff claims that Defendants von Eschenbach,

Leavitt, Pazdur, and Scher in their official capacities

violated his rights under the Administrative Procedure

Act (“APA”), 5 U.S.C. §§ 702, 704. In an official

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capacity lawsuit, the official’s employing agency is the

real partyin interest, and the suit “is, in all respects

other than name, to be treated as a suit against the

entity” that employs him. Kentucky v. Graham, 473

U.S. 159, 166 (1985). Though an official is named as

a defendant, an official capacity suit “is not a suit

against the official but rather is a suit against the

official’s office.” Will v. Mich. Dep’t of State Police, 491

U.S. 58, 71 (1989). Plaintiffs official capacity claims

are accordingly analyzed as brought against the

United States.

In their motion to dismiss, Defendants argue that

this Court lacks subject matter jurisdiction over this

action based on the doctrines of ripeness, finality, and

sovereign immunity. This Court agrees.

A. Ripeness

“The ripeness doctrine ‘is drawn both from Article

III limitations on judicial power and from prudential

reasons for refusing to exercise jurisdiction.’ “ Airline

Prof Ass’n of the Int'l Bhd. of Teamsters, Local Union

No. 1224, AFL-CIO v. Airborne, Inc. , 332 F.3d 983, 987

(6 Cir. 2003) (quoting Reno v. Catholic Soc. Servs.,

Inc., 509 U.S. 43, 57 n.18 (1993)). Ifa claim is unripe,

a federal court lacks subject matter jurisdiction and

the claim must be dismissed. Nationwide Mut. Ins.

Co. v. Cisneros, 52 F.3d 1351, 1361 (6th Cir. 1995).

The United States Supreme Court outlined the

ripeness doctrine in Abbott Labs. v. Gardner, 387 U.S.

136 (1967), and two companion cases, Toilet Goods

Ass’n, Inc. v. Gardner, 387 U.S. 158 (1967) and

:

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Gardner v. Toilet Goods Ass’n, Inc., 387 US. 167

(1967). Id. at 1361-62. The Court explained:

Without undertaking to survey the intricacies of

the ripeness doctrine it is fair to say that its

basic rationale is to prevent t’xe courts, through

avoidance of premature adjudication, from

entangling themselves in abstract

disagreements over administrative policies, and

also to protect the agencies from judicial

interference until an administrative decision

has been formalized and its effects felt in a

concrete way by the challenging parties.

The problem is best seen in a twofold aspect,

requiring us to evaluate both the fitness of the

issues for judicial decision and the hardship to

the parties of withholding court consideration.

Abbot Labs., 387 U.S. at 148-49. Further, to be ripe for

review, claims must satisfy both the fitness and the

hardship components of the inquiry. Cisneros, 52 F.3d

at 1361 (citing Franklin Fed. Sav. Bank v. Dir., Office

of Thrift Supervision, 927 F.2d 1332, 1336 (6th Cir.

1991)).

1. Fitness for Judicial Decision

The parties agree that, whether Plaintiffs official

capacity claims are fit for judicial resolution turns

upon (a) whether the claims raise purely legal

questions, and (b) whether the decisions they challenge

constitute final agency action. Toilet Goods Ass’n, 387

U.S. at 163-64; Abbot Labs., 387 U.S. at 149.

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a. Purely legal questions

In considering an issue’s fitness for judicial

decision, the Court’s analysis begins with determining

whether the issue is purely legal. Franklin Fed. Sav.

Bank, 927 F.2d at 1336 (“The Supreme Court began

with the fact that the issue before it in that case was

purely legal.” citing Abbot Labs, 387 U.S. at 149).

Although Plaintiff has raised many issues in its

Amended Complaint, Plaintiff submits that only one of

those issues is purely legal, i.e., “whether the FDA’s

prohibition to the access of Provenge to terminally ill

patients violates the Constitution.” (Doc. # 43 at 28.)

Defendants do not disagree with Plaintiffs contention;

however, Defendants correctly point out that Plaintiff

raises many issues in its official capacity claims that

are not purely legal and instead are fact-intensive.

Consequently, Plaintiff raises one purely legal

issue.

b. Final agency action

“Final agency action” is both a critical prerequisite

to Article II] justiciability, namely ripeness, and a

riecessary element of a cause of action under the APA.

5 U.S.C. § 704; Dalton v. Specter, 511 U.S. 462, 469

(1994). As this Court explains in detail infra, the

Complete Response Letter does not constitute final

agency action. Because the Provenge BLA

administrative process is ongoing, the FDA may

ultimately approve the application, which would

render Plaintiffs claims moot.

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Thus, this element of the test for fitness for judicial

decision is not met. Consequently, even though

Plaintiff raised one purely legal issue, that issue is not

fit for judicial decision. |

2. Hardship to the Parties of Withholding

Court Consideration

The final element considered under ripeness is

hardship to the parties in deferring consideration by

the courts. Abbott Labs. , 387 U.S. at 149. Defendants

correctly contend that Plaintiff faces no greater

hardship from waiting for a final agency decision

before bringing suit than the patients who might

potentially benefit from many other biologics or drugs

intended to treat life-threatening conditions that are

under review by the FDA at any given time. (Doc. # 38

at 18.) Indeed, Congress balanced such hardships

against the risks and dangers of using unsafe and

ineffective drugs when it set the statutory standards

for approval of drugs and biologics. See, e.g., United

States v. Rutherford, 442 U.S. 544, 552-53 & n.9, 556

(1979) (discussing Congressional intent and legislative

history, especially in context of risks borne by

terminally ill cancer patients).

The FDA’s issuance of the Complete Response

Letter, at most, potentially prevents access to an

unproven and speculative future benefit. Moreover,

immediate consideration of the administrative record

by this Court could not speed patients’ access to

Provenge, because the only remedy that this Court

could issue is a remand to the FDA to continue its

review of Dendreon’s BLA. Fla. Power & Light Co. v.

Lorion, 470 U.S. 729, 744 (1985); (Doc. # 33 at 35-36.)

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3. Conclusion Ripeness Test

Plaintiff failed to satisfy either prong of the

ripeness test — fitness for judicial resolution and

hardship from delaying judicial consideration. Under

these circumstances, it is without question that

Plaintiffs claims are manifestly unripe leaving this

Court with no subject matter jurisdiction to hear

Plaintiffs official capacity claims.

B. Finality

Even this Court did not lack subject matter

jurisdiction over the official capacity claims because

they are unripe, the claims would still be dismissed

under the doctrine of finality. The APA permits

judicial review of “final agency action for which there

is no other adequate remedy in a court.” 5 U.S.C.

§ 704. “Final agency action” is a necessary element of

a cause of action under the APA. Id.; Dalton uv.

Specter, 511 U.S. 462, 469 (1994). Indeed, if an action

does “not constitute ‘final agency action’ as used under

the APA, the district court lacks subject matter

jurisdiction to evaluate the complaint...” Invention

Submission Corp. v. Rogan, 357 F.3d 452, 460 (4th Cir.

2004) Gif the action did “not constitute ‘final agency

action’ as used under the APA, the district court did

not have subject matter jurisdiction to evaluate the

complaint under Rule 12(b)\(6) and should have

dismissed this case under Rule 12(b)(1)”).

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As the United States Supreme Court has explained,

two conditions must be satisfied for agency action to be

final:

First, the action must mark the ‘consummation’

of the agency’s decisionmaking process—it must

not be of a merely tentative or interlocutory

nature. And second, the action must be one by

which “rights or obligations have been

determined” or from which “legal consequences

will flow.”

Bennett v. Spear, 520 U.S. 154, 177-78 (1997) (citations

omitted). See also Franklin v. Massachusetts, 505 U.S.

788, 797 (1992) (“The core question is whether the

agency has completed its decisionmaking process, and

whether the result of that process is one that will

directly affect the parties.”). In addition, the action

must not be that of a subordinate official. Franklin,

505 U.S. at 797 (internal quotation marks omitted;

quoting Abbott Labs. v. Gardner, 387 U.S. 136, 151

(1967)); Air Brake Sys. v. Mineta, 357 F.3d 632, 640

(6th Cir. 2004) (quoting same passage from Abbott

Labs.). None of these conditions is satisfied in the

instant action.

The agency action at issue here is the issuance of

the Complete Response Letter. Although Plaintiff

acknowledges that it must show that the agency action

is final, Plaintiff sets forth an entire two pages of

factual assertions—including direct quotes—without so

much as one citation to the evidentiary source of the

assertions. (Doc. # 43 at 15-17.) However, even if this

Court were to accept Plaintiffs factual assertions,

Plaintiff has utterly failed to apply the applicable law

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to those facts. Indeed, as Defendants correctly state:

“The total of [Plaintiffs] analysis on final agency

action is the conclusory assertion that any ‘argument’

that ‘there has been not final decision made . . . lacks

-any merit what so ever and is close to laughable.”

(Doc. # 47 at 4-5 citing Doc. # 43 at 17.) Plaintiffs

conclusory statement falls far short of supporting

Plaintiffs claim that the issuance of the Complete

Response Letter constitutes final agency action.

In glaring contrast, Defendants have convincingly

shown that issuance of a Complete Response Letter

does not constitute final agency action. (Doc. # 38 at

12-19; Doc. # 47 at 1-7.) A Complete Response Letter

is an established mechanism for the FDA to request

additional information from the sponsor of a BLA.

_ FDA, Applications for Approval to Market a New Drug,

69 Fed. Reg. 43351, 43352 (July 20, 2004). A Complete

Response Letter is meant to “ensure a consistent

approach to informing sponsors of needed changes

before [the FDA] can approve an application, with no

implication as to the ultimate approvability of the

application.” Id. AComplete Response Letter does not

signal the end for a product; rather, it is a step the

FDA takes to assure that it has sufficient data to

establish safety and effectiveness prior to licensure.

The FDA continues to work with sponsors to resolve

any outstanding issues. See id.

Indeed, the Complete Response Letter made clear

that it was not “the consummation of the agency’s

decisionmaking process” and instead was an

interlocutory step in the agency’s administrative

process. See Dendreon Receives Complete Response

Letter. The letter affirmatively requests Dendreon to

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submit additional evidence to support its BLA. See id.

(“The FDA has requested additional clinical data in

support of the efficacy claim contained in the BLA.”).

In its press release, Dendreon explained that “[w]Je are

committed to working closely with the FDA to resolve

these questions in a timely and efficient manner.” Id.

Thus, Dendreon clearly understood the letter to be “of

a merely ... interlocutory nature.” Bennett, 520 U.S.

at 178. Because the Provenge BLA administrative

process is ongoing, the FDA may ultimately approve

the application, which would render Plaintiffs claims

moot. Under these circumstances, the challenged FDA

action is clearly not a “final agency action” as that

phrase is interpreted under the APA. 5 U.S.C. § 704.

See also Telespectrum, Inc. v. Pub. Serv. Comm’n of

Ky., 227 F.3d 414, 423 (6th Cir. 2000) (the agency’s

order “contain[led] no language which indicates that

PSC will hear further evidence”).

In addition, the Complete Response Letter did not

determine any legal rights or obligations, or trigger a

process “from which legal consequences will flow.”

Bennett, 520 U.S. at178 (internal quotation marks and

citations omitted). To be sure, makers of biologic

products cannot market them without an approved

BLA. 42 U.S.C. § 262(a). But the Complete Response

Letter neither approved, nor denied, Dendreon’s BLA.

It thus did not “alter the legal regime” and “in no way

affected the legal rights of the relevant actors.”

Bennett, 520 U.S. at 178.

Finally, the Complete Response Letter was the

ruling of a subordinate official. It was signed by Dr.

Ashok Batra, who is the Director of the Division of

Clinical Evaluation and Pharmacology/Toxicology

23a

within the Office of Cellular, Tissue, and Gene

Therapies, which is in turn within CBER. CBER has

delegated to officials at Dr. Batra’s level the authority

to issue Complete Response Letters, but not the

authority to approve BLAs. CBER, “Signature

Authority for Action Letters,” Sept. 20, 2004, in Manual

of Standard Operating Procedures and Policies, SOPP

8405, ver. 4, App. 1, available at http://www.fda.gov/

cber/regsopp/8405sign.htm. In Air Brake Systems, the

Sixth Circuit found that actions taken by subordinate

officials did not constitute “final agency action”:

“While [the agency]’s Chief Counsel has considerable

authority over purely legal interpretations of pertinent

statutes and regulations, the Secretary has not

delegated authority to the Chief Counsel to make final

fact-bound determinations of compliance with [the

agency]’s safety standards.” Air Brake Sys., 357 F.3d

at 640. Because the FDA’s Complete Response Letter

was “only the ruling of a_ subordinate official,”

Franklin v. Massachusetts, 505 U.S. 788, 797 (1992), to

whom the Commissioner has not delegated authority

to approve BLAs, it was not a final agency action. See

also Air Brake Sys., 357 F.3d at 640.

Accordingly, because the Complete Response Letter

does not constitute final agency action under the APA,

this Court lacks subject matter jurisdiction over this

action and must dismiss it.

C. Sovereign Immunity

Even if the official capacity claims did not lack

subject matter jurisdiction based upon the doctrines of

finality and ripeness, it would still be dismissed based

upon the doctrine of sovereign immunity. “Jurisdiction

24a

over any suit against the [United States] Government?

requires a clear statement from the United States

waiving sovereign immunity . . . together with a claim

falling within the terms of the waiver.” United States

v. White Mountain Apache Tribe, 537 U.S. 465; 472

(2003). Indeed, it is “axiomatic that the United States

may not be sued without its consent and that the

existence of consent is a prerequisite for jurisdiction.”

United States v. Mitchell, 463 U.S. 206, 212 (1983); see

also Reed v. Reno, 146 F.3d 392, 398 (6th Cir. 1998)

(“The United States can be sued only when it has

expressly given its consent to be sued.”) (internal

quotation marks and citation omitted).

Waivers of sovereign immunity “cannot be implied

but must be unequivocally expressed.” Mitchell, 463

U.S. at 239; Reed, 146 F.3d at 398 (waiver must be

“express, clear and unequivocal”). Thus, absent an

express waiver of sovereign immunity, a district court

lacks jurisdiction over claims against the United

States. See, e.g., Mitchell, 463 U.S. at 212. It is

Plaintiffs burden to “identify a waiver of sovereign

immunity in order to proceed against the United

States. If [it] cannot identify a waiver, the claim must

* The FDA is part of the Department of Health and Human

Services, 21 U.S.C. § 393(a), which Congress has established as

one of the fourteen Executive Branch departments, 5 U.S.C. § 101.

Sovereign immunity is thus fully applicable to actions brought

against the FDA andor its officials. See, e.g., NVE Inc. v. HHS,

436 F.3d 182, 189 (3d Cir. 2006) (holding that challenge to FDA

regulation banning dietary supplements containing ephedra must

proceed under APA because Dietary Supplement Health and

Education Act did not provide a private cause of action or “contain

a waiver of sovereign immunity that would permit [plaintiff] to

sue a federal agency”).

25a

be dismissed on jurisdictional grounds.” Reetz v.

United States, 224 F.3d 794, 795 (6th Cir. 2000).

In the case sub judice, Plaintiff argues that “[t]here

is no immunity for intentional conduct done with

malice that rises to the level of a constitutional tort”

and thus asserts that “[nJeither the government itself

nor the government officials Dr. von Eschenbach, Dr.

Scher, and Dr. Pazdur have immunity from being

sued.” (Doc. # 43 at 80.) This argument, however, as

Defendants correctly note, confuses sovereign

immunity with the concept of qualified immunity that

is applicable only to Plaintiffs claims against Pazdur

and Scher in their individual capacity. Plaintiffs

reliance on caselaw concerning the standards for

imposing individual liability on government officials is

thus misplaced. Jd. at 80-82. |

Plaintiffs next argument centers on a series of

United States Supreme Court decisions from the 1930s

and 1940s that dealt with government-chartered

corporations authorized to conduct financial business

transactions and to “sue and be sued” in their own

name. Id. at 81 (citing Keifer & Keifer v.

Reconstruction Fin. Corp., 306 U.S. 381 (1939)

(Reconstruction Finance Corp.); FHA v. Burr, 309 U.S.

242 (1940) (Federal Housing Administration);

Reconstruction Fin. Corp. v. Menihan Corp., 312 U.S.

81 (1941) (Reconstruction Finance Corp); and

Standard Oil Div. v. Starks, 528 F.2d 201 (7th Cir.

1975) (United States Postal Service)). The rulings in

those cases were based on findings that Congress had

not meant to endow such entities with sovereign

immunity. Plaintiff here appears to rely on these

cases for support of its contention that the FDA

26a

likewise lacks immunity from suit. Plaintiff's reliance,

however, is misplaced.

Even assuming these decisions are still good law,

the FDA is not a quasi-governmental business entity

or private corporation like the Reconstruction Finance

Corporation or the Postal Service, nor can it sue and

be sued in its own name. See Parrett v. Se. Boll Weevil

Eradication Found., Inc., 155 Fed. Appx. 188, 191 (6th

Cir. 2005) (questioning continued authority of Keifer

and its progeny); Galvan v. Fed. Prison Indus., Inc.,

199 F.3d 461, 467 (D.C. Cir. 1999) (same). Rather, the

agency is part of the Department of Health and

Human Services, 21 U.S.C. § 393(a), which Congress

has established as one of the fourteen Executive

Branch departments, 5 U.S.C. § 101. Sovereign

immunity is thus fully applicable to actions brought

against the FDA and/or its officials. See, e.g., NVE Inc.

v. HHS, 436 F.3d 182, 189 (3d Cir. 2006) (holding that

challenge to FDA regulation banning dietary

supplements containing ephedra must proceed under

APA because Dietary Supplement Health and

Education Act did not provide a private cause of action

or “contain a waiver of sovereign immunity that would

permit [plaintiff] to sue a federal agency”).

Plaintiff next argues that this Court should

“exercise its power of equity jurisdiction,” by which

Plaintiff presumably means the Court’s power to enter

injunctive or other equitable relief where a plaintiff

has no adequate legal remedy. (Doc. # 43 at 82-83.)

Although it is unclear whether Plaintiff asserts this

argument as a means to avoid the bar of sovereign

immunity or for some other purpose, it goes without

saying that a court’s exercise of equitable authority

27a

depends in the first instance on the existence of subject

matter jurisdiction. See Mickler v. Nimishillen &

Tuscarawas Ry. Co., 13 F.3d 184, 189 (6th Cir. 1993);

see also Wooten v. United States, 825 F.2d 1039, 1045

(6th Cir. 1987) (“Since federal courts are courts of

limited jurisdiction, jurisdiction that is otherwise

lacking cannot be conferred by [equitable doctrines

such as] consent, collusion, laches, waiver, or

estoppel.”).

For the same reason, i.e., lack of subject matter

jurisdiction, Plaintiffs reference to declaratory relief

under Rule 57 of the Federal Rules of Civil Procedure

is equally unavailing. (Doc. # 43 at 85.) The

Declaratory Judgment Act, 28 U.S.C. § 2201, does not

waive sovereign immunity or create an independent

basis for jurisdiction, but merely provides courts with

the discretion to fashion a remedy. See Heydon uv.

MediaOne of Se. Mich., Inc., 327 F.3d 466, 470 (6th

Cir. 2003). Thus, declaratory relief, like injunctive

relief, is only available if the court otherwise has

subject matter jurisdiction over the action.

Finally, Plaintiff turns to the APA,’ observing

correctly that, although the APA does not itself confer

subject matter jurisdiction, it does waive sovereign

immunity for certain nonmonetary claims against the

United States. (Doc. # 43 at 84); 5 U.S.C. §§ 702, 704.

* In the Amended Complaint, Plaintiff relies on a number of other

sources for subject matter jurisdiction. In Defendants’ Motion to

Dismiss, however, Defendants correctly explain that none of the

named sources waives the sovereign immunity to which

Defendants are entitled. (Doc. # 38 at 30-34.) Plaintiff,

appropriately, does not dispute Defendants’ conclusions.

28a

However, by its terms, the APA authorizes challenges

only to “final agency action for which there is no other

adequate remedy in court.” Beamon v. Brown, 125

F.3d 965, 967 (6th Cir. 1997) (“Although the APA

provides a broad waiver of sovereign immunity,

codified at 5 U.S.C. § 702, the waiver is limited... .

{[U]nder the APA, a federal district court may only

review ‘[a]gency action made reviewable by statute and

final agency action for which there is no other

adequate remedy in a court.’ “). Such statutory

waivers of sovereign immunity are “strictly construed

in favor of the United States.” Reed, 146 F.3d at 398.

In the instant action, this Court has already

concluded that a Complete Response Letter is in no

sense a “final agency action.” Consequently, Plaintiff

has not stated a claim under the APA, which prevents

it from availing itself to the APA’s waiver of sovereign

immunity. Because Plaintiff has failed to identify any

waiver of sovereign immunity applicable to its claims,

its complaint must be dismissed for lack of subject

matter jurisdiction.

V. CONCLUSION

This Court lacks subject matter jurisdiction over

the official capacity claims brought against Defendants

based on the doctrines of ripeness, finality, and

sovereign immunity. Therefore, the Court GRANTS

Defendants’ Motion to Dismiss Plaintiffs Official

Capacity Claims (Doc. #38) and GRANTS Defendants’

Motion to Strike Improper Supplemental

Memorandum (Doc. # 59).

IT IS SO ORDERED.

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APPENDIX C

5 U.S.C. § 702

United States Code Annotated Currentness

Title 5. Government Organization and

Employees (Refs & Annos)

Part I. The Agencies Generally

Chapter 7. Judicial Review (Refs & Annos)

5 U.S.C. § 702. Right of review

A person suffering legal wrong because of agency

action, or adversely affected or aggrieved by agency

action within the meaning of a relevant statute, is

entitled to judicial review thereof. An action in a court

of the United States seeking relief other than money

damages and stating a claim that an agency or an

officer or employee thereof acted or failed to act in an

official capacity or under color of legal authority shall

not be dismissed nor relief therein be denied on the

ground that it is against the United States or that the

United States is an indispensable party. The United

States may be named as a defendant in any such

action, and a judgment or decree may be entered

against the United States: Provided, That any

mandatory or injunctive decree shall specify the

Federal officer or officers (by name or by title), and

their successors in office, personally responsible for

compliance. Nothing herein (1) affects other

limitations on judicial review or the power or duty of

the court to dismiss any action or deny relief on any

3la

other appropriate legal or equitable ground; or (2)

confers authority to grant relief if any other statute

that grants consent to suit expressly or impliedly

forbids the relief which is sought.

CREDIT(S)

(Pub.L. 89-554, Sept. 6, 1966, 80 Stat. 392; Pub.L. 94-

574, § 1, Oct. 21, 1976, 90 Stat. 2721.)

5 U.S.C. § 704

United States Code Annotated Currentness

Title 5. Government Organization and

Employees (Refs & Annos)

Part I. The Agencies Generally

Chapter 7. Judicial Review (Refs & Annos)

5 U.S.C. § 704. Actions reviewable

Agency action made reviewable by statute and final

agency action for which there is no other adequate

remedy in a court are subject to judicial review. A

preliminary, procedural, or intermediate agency action

or ruling not directly reviewable is subject to review on

the review of the final agency action. Except as

otherwise expressly required by statute, agency action

otherwise final is final for the purposes of this section

whether or not there has been presented or

determined an application for a declaratory order, for

any form of reconsideration, or, unless the agency

otherwise requires by rule and provides that the action

meanwhile is inoperative, for an appeal to superior

agency authority.