                            UNITED STATES DISTRICT COURT
                            FOR THE DISTRICT OF COLUMBIA
____________________________________
                                    )
STAT-TRADE INC.,                    )
                                    )
                  Plaintiff,        )
                                    )
      v.                            )                 Civil Action No. 11-1789 (ABJ)
                                    )
FOOD AND DRUG                       )
ADMINISTRATION, et al.,             )
                                    )
                  Defendants.       )
____________________________________)


                                  MEMORANDUM OPINION

       Plaintiff Stat-Trade, Inc. (“Stat-Trade”) brings this action against the United States Food

and Drug Administration (“FDA”), its commissioner Margaret Hamburg, and the Secretary of

the Department of Health and Human Services, Kathleen Sebelius, for declaratory, mandamus,

and injunctive relief. Stat-Trade is a small pharmaceutical company subject to fees under the

Prescription Drug User Fee Act of 1992, as amended (“PDUFA”). It has filed a motion for

summary judgment, [Dkt. # 19], and defendants have moved to dismiss or, in the alternative, for

summary judgment, [Dkt. # 20].

       Stat-Trade asserts two claims: first, it argues that since fiscal year 2009, FDA has

required Stat-Trade to pay yearly fees for two pharmaceutical products that should have been

exempt under the statute. The Court finds that the two products do fall under the statutory

exception. However, since Stat-Trade failed to contest the charges from fiscal years 2009–2011

within the statutorily mandated time, it is barred from asserting the exception for those fees now.

Accordingly, the Court will grant Stat-Trade’s motion for summary judgment on Count I as to

the fiscal year 2012 fees, but will deny it as to the fiscal year 2009–2011 fees.
        Second, Stat-Trade argues that FDA has unreasonably delayed reviewing certain of its

requests for waivers from fiscal years 2009–2011. Because the Court finds that Stat-Trade’s

claim is moot as to the 2009 and 2010 waiver applications, and that Stat-Trade has failed to show

that FDA unreasonably delayed reviewing the 2011 waiver application, the Court will grant

summary judgment for defendants and deny Stat-Trade’s motion on Count II.

                               STATUTORY BACKGROUND

        The PDUFA governs FDA’s assessment of fees for prescription drug applicants and

application holders. 21 U.S.C. §§ 379g, 379h. The fees at issue here are annual product fees,

which FDA assesses separately for each “prescription drug product.” The statute defines a

“prescription drug product” as “a specific strength or potency of a drug in final dosage form” that

has been approved by FDA, that may be dispensed only by prescription, and that is included on

the FDA’s list of approved drug products that are being actively marketed that year. 21 U.S.C.

§§ 379g(3), 379h(a)(3)(A). This definition reflects amendments made by Congress in 2002 and

2007.

        It was in 2002 that Congress amended the definition of “prescription drug product” to

include reference to the “Approved Drug Products with Therapeutic Equivalence Evaluations”

list, informally known as the “Orange Book.” See 21 U.S.C. § 379g(3) (2002). The Orange

Book is divided into the “active” section, which lists approved drug products that are in

commercial production, and the “discontinued” section, which lists those that are not.

Administrative Record (“AR”) 265. The 2002 Amendments clarified that a “prescription drug

product” must be “on the list of products described in section 505(j)(7)(A) or [] on a list created

and maintained by the Secretary of products approved under human drug applications under




                                                2
section 351 of the Public Health Service Act.” H.R. Rep. No. 107-481, at 95 (2002). The

accompanying Conference Report stated:

                The term “prescription drug product” is modified to allow the Secretary to
        use the Prescription Drug Product List (the active portion) in the “approved Drug
        Products with Therapeutic Equivalence Evaluations,” (the Orange Book) as the
        basis for identifying which products should be considered to be prescription drug
        products for fee assessment purposes.

Id. at 149, reproduced at AR 149. In 2007, Congress further amended the PDUFA definition of

“prescription drug product” to expressly clarify that fees should be assessed for a drug on the list,

but “not including the discontinued section of such list.” 21 U.S.C. § 379g(3)(C) (2007).

        FDA typically sends out invoices in August for fees assessed for the upcoming fiscal

year. AR 226. Fees are due on October 1, and failure to pay in full by October 31 subjects a

company to financial penalties, interest, and administrative fees as well as arrearage, meaning

that FDA will not accept any application or supplement filing from that company until all owed

fees are paid. 21 U.S.C. §§ 379h(a)(3)(A), (e).

        The PDUFA also contains a product fee exception and two waiver provisions that are

relevant to this case:

    •   Section 379h(a)(3)(B) excepts a “prescription drug product” from product fees if

        “such product is the same product as another product approved under an

        application [for generic drug approval] under … 355(j) of this title.” 1 21 U.S.C.

        § 379h(a)(3)(B).   The parties dispute whether this exception applies in any

        situation where an equivalent generic has been approved by FDA or whether it

        applies only when the generic is being actively marketed.




1       The Court will refer to this provision as the “generic exception.”

                                                  3
   •   Section 379h(d)(1)(B) requires FDA to grant a partial or complete waiver of fees

       to any company that can demonstrate that “the assessment of the fee would

       present a significant barrier to innovation because of limited resources available

       to such person or other circumstances.” 2 21 U.S.C. § 379h(d)(1)(B). Plaintiff has

       asserted this waiver.

   •   Section 379h(d)(1)(C) requires a fee waiver if the fees “will exceed the

       anticipated present and future costs incurred by the Secretary in conducting the

       process for the review of human drug applications for such person.” 3 21 U.S.C. §

       379h(d)(1)(C). Plaintiff has also asserted this waiver. 4

                                 FACTUAL BACKGROUND

       Stat-Trade is a small pharmaceutical company that currently owns and holds FDA

approval for the prescription anti-inflammatory drug Naprelan in three different dosage



2      The Court will refer to this provision as the “barrier-to-innovation waiver” or “BTI
waiver.”

3      The Court will refer to this provision as the “fees-exceed-the-costs waiver” or “FEC
waiver.”

4        FDA uses cumulative fees and costs, beginning in September 1, 1992 – when the PDUFA
program was inaugurated – and ending in the year for which the waiver is requested. Defs.’
Mem. in Support of Mot. for Summ. J. (“Defs.’ MSJ”) [Dkt. # 20-2] at 8–9. In other words,
FDA adds all of the fees that the company and its affiliates have paid since September 1, 1992,
and then subtracts the total costs that FDA has expended on reviewing their applications and
supplements since the same date. The difference is the waiver amount. Important to this case,
however, is a provision of the PDUFA that authorizes FDA to use “standard costs” in assessing
FEC waivers. 21 U.S.C. § 379h(d)(3). Citing this provision, FDA has adopted a complicated
method of calculating a company’s “standard costs.” See AR 184–89. In simplified form, FDA
first determines the average cost of processing each type of application and supplement that was
submitted during that year, and then adds up the standard costs for each application and
supplement that the company and its affiliates have submitted since 1992. The sum is the
“standard cost” for that company, which is subtracted from the fee amount in order to determine
the amount of the waiver.

                                                 4
strengths. See AR 6, 150. In 2002 and 2003, FDA approved a competitor’s applications for

generic versions of Naprelan in two of the three strengths (375 mg and 500 mg), and the generic

drugs went into commercial production. AR 257. However, in 2009, after an adverse decision

in a patent infringement lawsuit, the generic manufacturer discontinued its sales of the generics.

AR 77–78. 5 When the generics went off the market, FDA began assessing Stat-Trade product

fees for all three strengths of Naprelan, including the two with approved generic counterparts,

and it has continued to do so for fiscal years 2009–2012. 6 AR 1–2, 5, 16, 65–68.

       The fiscal year 2010 invoice was the first to assess product fees for all three dosage

strengths of Naprelan. AR 1. It was issued by FDA on August 14, 2009. Id.             Nearly four

months later, FDA issued Stat-Trade a second invoice for Naprelan PDUFA fees – this one for

fiscal year 2009. AR 2, 5.

       On April 6, 2011, Stat-Trade wrote FDA and requested an exception. AR 22–24. It

asserted that the 375 mg and 500 mg strengths of Naprelan should be exempt from product fees

under the generic exception, and it asked FDA to apply the exception to its invoices for fiscal

years 2009–2011. Id. The letter also requested that FDA apply the exception to all future

PDUFA invoices. AR 23. In support of its request, Stat-Trade took the position that the PDUFA

exception covers product fees for all prescription drug products with approved generic

counterparts, regardless of the generic drug’s market status.      AR 22–23.     Since FDA had




5      Neither the manufacturer nor FDA withdrew approval of the generic products or
withdrew the abbreviated new drug application (“ANDA”) under which they were approved.
AR 78, 263.

6      FDA actually issues Stat-Trade’s product fee invoices to the company’s affiliate, STI
Pharma LLC, see, e.g., AR 1, 2, 16, 66, but for the sake of convenience, the Court will refer to
both STI Pharma LLC and Stat-Trade, Inc. as “Stat-Trade.”


                                                5
approved generic versions of two strengths of Naprelan, Stat-Trade argued, that exception

applied to those two products. Id.

       FDA did not respond to Stat-Trade’s request at that time. Instead, it sent Stat-Trade a

draft invoice for fiscal year 2012. AR 25–32. This invoice again assessed product fees for all

three strengths of Naprelan. AR 31. Stat-Trade contacted FDA on three occasions to assert that

the two strengths of Naprelan should be exempt from product fees under the PDUFA generic

exception, and to request that FDA apply the generic exception to the final 2012 invoice. AR

35–37, 38–39, 57–59. Without responding to any of Stat-Trade’s requests, FDA issued a final

invoice on August 15, 2011, assessing product fees for all three versions of Naprelan. AR 65–

68. Payment was due October 1, 2011. 7 AR 65–68.

       Meanwhile, in February 2010, Stat-Trade submitted barrier-to-innovation and fees-

exceed-the-costs waiver requests for fiscal years 2009 and 2010. AR 4–8. Six months later,

FDA denied Stat-Trade’s BTI waiver request and notified Stat-Trade of its appeal rights. AR 9–

15. In the same letter, FDA stated that it had not yet considered Stat-Trade’s FEC waiver

request, and explained that it planned to defer consideration until after the appeal was completed

or after it received notification that Stat-Trade had decided not to appeal. AR 14. Stat-Trade

appealed the decision by letter in September 2010. AR 17. In the same letter, it also requested

BTI and FEC waivers for fiscal year 2011. Id.

       While Stat-Trade’s generic exception and waiver requests were pending, its 2009 to 2011

invoices became overdue. AR 54. As a result, Stat-Trade sat in arrears for over a year and a half




7        After the final invoice was issued, Stat-Trade challenged it again by formally requesting
that the 375 mg and 500 mg strengths of Naprelan be excepted from product fees, AR 69–74, but
it later withdrew the request, AR 148.
                                                6
and accumulated $234,831 in penalties and interest, until one of its affiliates agreed to pay the

total amount as part of a transfer of rights to market Naprelan. AR 54–56.

       Stat-Trade filed this suit, along with a motion for preliminary injunction on October 7,

2011, in an attempt to force FDA to review its generic exception and waiver requests before the

next installment of PDUFA fees would become due. [Dkt. # 1, 5]. As of that date, FDA had not

ruled on any of the outstanding disputes: the 2009 and 2010 BTI waiver appeals, the BTI waiver

request for fiscal year 2011, the FEC waiver requests for 2009–2011, or the generic exception

requests for 2009–2012 and thereafter. The Court held several conferences with the parties, and

ultimately, in return for Stat-Trade’s agreement to withdraw its motion for preliminary

injunction, FDA agreed to rule on Stat-Trade’s BTI and FEC waiver requests as well as its

generic exception request. See Minute Order (Oct. 18, 2011); Minute Order (Oct. 25, 2011);

Minute Order (Oct. 27, 2011).

       On October 21, FDA issued a decision denying all three of Stat-Trade’s BTI waiver

requests. AR 150–63. On October 27, FDA issued a decision partially granting Stat-Trade’s

FEC waiver requests for fiscal years 2009 and 2010, and agreeing to refund Stat-Trade $299,367.

AR 178–180. However, it refused to decide Stat-Trade’s fiscal year 2011 waiver request on the

grounds that it could not issue its final determination until it had calculated its standard costs for

fiscal year 2011, which, it estimated, would not occur until June 2012 at the earliest. AR 192

n.7.

       Finally, on October 31, FDA took a formal position on the availability of the generic

exception. It issued a letter of determination denying Stat-Trade’s request for correction of its

fiscal year 2012 invoice on the merits, and denying requests for corrections of the fiscal year

2009–2011 invoices as time barred. AR 234–38.



                                                  7
       Stat-Trade filed a second amended complaint on November 10, 2011. [Dkt. # 15]. Count

I deals with the generic exception and alleges that FDA’s assessment of product fees for the two

strengths of Naprelan for which generics have been approved violates the PDUFA and exceeds

FDA’s authority, in violation of the Administrative Procedure Act (“APA”), 5 U.S.C. §§

706(2)(A), (C). Second Am. Compl. ¶¶ 64–67. Count II alleges that FDA’s delay in acting upon

Stat-Trade’s fiscal year 2011 FEC waiver request for at least twenty-one months in order to

calculate standard costs constitutes agency action unreasonably delayed and is arbitrary and

capricious, in violation of the APA, 5 U.S.C. §§ 706(1), (2)(A). Id. ¶ 69. Count II also alleges

that FDA’s refusal to consider Stat-Trade’s 2009 and 2010 FEC waiver requests until after Stat-

Trade either exhausted or abandoned its appeal rights for the BTI waiver requests was agency

action unreasonably delayed and arbitrary and capricious, in violation of the APA. Id. It further

claims that FDA’s final action imposing penalties, interest, and administrative charges on the

portion of Stat-Trade’s unpaid fees that should have been waived was arbitrary and capricious

with respect to the period during which FDA unlawfully withheld action on those waiver

requests. Id. ¶ 70. The parties have cross-moved for summary judgment on both counts. [Dkt. #

19, 20].

                                  STANDARD OF REVIEW

       The APA establishes the scope of judicial review of agency action, see Vermont Yankee

Nuclear Power Corp. v. Natural Res. Def. Council, Inc., 435 U.S. 519, 545–549 (1978), and the

standard of review under the APA is quite narrow.

       Courts are required to analyze an agency’s interpretation of a statute by following the

two-step procedure set forth in Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S.

837 (1984). First, the court must determine “whether Congress has directly spoken to the precise



                                               8
question at issue.” Id. at 842. “If the intent of Congress is clear, that is the end of the matter; for

the court, as well as the agency, must give effect to the unambiguously expressed intent of

Congress.” Id. at 842–43. Courts “use ‘traditional tools of statutory construction’ to determine

whether Congress has unambiguously expressed its intent,” Serono Labs., Inc., v. Shalala, 158

F.3d 1313, 1319 (D.C. Cir. 1998), including an examination of the statute’s text, structure,

purpose, and legislative history. Bell Atl. Tel. Co. v. FCC, 131 F.3d 1044, 1047 (D.C. Cir. 1997).

If the court concludes that the statute is either silent or ambiguous, the second step of the court’s

review process is to determine whether the interpretation proffered by the agency is “based on a

permissible construction of the statute.” Chevron, 467 U.S. at 843.

       Once a reviewing court reaches the second step, it must accord “considerable weight” to

an executive agency’s construction of a statutory scheme it has been “entrusted to administer.”

Id. at 844. Indeed, “under Chevron, courts are bound to uphold an agency interpretation as long

as it is reasonable – regardless whether there may be other reasonable or, even more reasonable,

views.” Serono, 158 F.3d at 1321. And the court must defer to an agency’s reading of its own

regulations unless it is “plainly erroneous or inconsistent with the regulation.” Id. at 1320

(internal quotation marks omitted).

                                            ANALYSIS

       The Court agrees with the parties that this case presents pure questions of law that should

be decided on summary judgment. 8 Count I of the second amended complaint asks the Court to

determine whether Stat-Trade is entitled to reimbursement of product fees it paid for the 375 and

500 mg strengths of Naprelan for fiscal years 2009–2012 as well as the amounts it paid to FDA


8      FDA has alternatively moved to dismiss the two counts under Federal Rule of Civil
Procedure 12(b)(6), but since the Court relies on parts of the Administrative Record in ruling on
the merits of this case, it will deny the motion to dismiss and proceed to review the merits of
FDA’s arguments under its motion for summary judgment.
                                                  9
in penalties, interest, and administrative charges for its late payment of product fees for fiscal

years 2009–2011. This presents two distinct legal questions:

           1) Whether FDA exceeded its authority under the PDUFA by interpreting the
              generic exception provision to be limited to situations where the generic is
              not only “approved,” but also in active production; and

           2) If the Court finds that the exception should have applied, whether FDA
              abused its discretion and acted in excess of statutory authority by denying
              Stat-Trade’s request to correct the FY 2009–2011 invoices on the grounds
              that they were time barred by 21 U.S.C. § 379h(i).

        Count II of the complaint asks the Court to determine whether Stat-Trade is entitled to

reimbursement for the penalties, interest, and administrative fees that it paid to FDA for the late

payment of fees that were eventually waived under the FEC waiver provision of PDUFA. This

count also presents two distinct legal questions:

           1) Whether FDA’s decision to defer processing Stat-Trade’s 2011 FEC
              waiver request until it can determine standard costs for that year
              constitutes unreasonable delay and is arbitrary and capricious; and

           2) Whether it was arbitrary and capricious for FDA to refuse to review Stat-
              Trade’s 2009–2010 FEC waiver requests until Stat-Trade had abandoned
              or exhausted its appeals for its BTI waiver requests.

        The Court will address each issue in turn.

   I.      Count I: Assessment of product fees for Naprelan 375 mg and 500 mg strengths

           A. FDA’s consideration of marketing status under the generic exception provision

        The exception at issue in this case reads: “A prescription drug product shall not be

assessed a fee under subparagraph (A) . . . if such product is the same product as another product

approved under an application filed under section 355(b) or 355(j) [“abbreviated new drug

applications”] . . . .” 21 U.S.C.A. § 379h(a)(3)(B). Plaintiff contends that since generic versions

of the 375 and 500 mg strength Naprelan tablets were “approved” under an abbreviated new drug

application (“ANDA”) in 2002 and 2003, those products should be exempt from the assessment

                                                10
of fees under the plain terms of the statute, notwithstanding the fact that in 2009, the

manufacturer of the generics ceased their production.

       Essentially, according to plaintiff, “approved” means “approved.” Plaintiff points to the

fact that the exception contains no express requirement that the equivalent generic product be

available on the market – the applicability of the exception is triggered simply by the action of

FDA in approving the generic product. In addition, under the FDA regulations that govern

generic drug applications, “approval” is a specific event, see 21 C.F.R. § 314.105(d) (2008)

(“The approval becomes effective on the date of the issuance of the agency’s approval letter

unless the approval letter provides for a delayed effective date.”), and approval remains effective

whether or not the product is commercially marketed. 9 Id.

       Plaintiff notes that dating back to 1994, the agency itself read the statute as Stat-Trade

seeks to do now. It directs the Court to the first page of a December 16, 1994 publication

entitled: Application, Product, and Establishment Fees: Common Issues and Their Resolution:

       The marketing status of the 505(b)(2) or 505(j) application [an application under
       21 U.S.C. §355(b) or (j)] . . . is not a determining factor. If the 505(b)(2) or (j)
       application has been approved and not withdrawn, the first approved product is
       excluded from fees even if the generic product is not presently marketed.

AR 247–52. Plaintiff argues that FDA was right in 1994, and that since the language of the

exception itself has not changed since the issuance of this policy guidance, the Court can decide

at the Chevron step one stage that the exception still applies.

       FDA cannot fairly dispute that the statute calls for the generic that triggers applicability

of the exception to be “approved” and no more, so it attempts to shift the focus from the word


9       These provisions were first published in the Federal Register as part of a proposed rule in
1989, see 54 Fed. Reg. 28872, 28928 (July 10, 1989) – well before 1992 when the PDUFA was
first enacted. They were published in final form in 1992. See 57 Fed. Reg. 17950, 17989 (Apr.
28, 1992).

                                                 11
“approved” to the phrase “same product.” It claims that Congress left a gap or ambiguity in the

text when it failed to define the phrase “same product” in section 379h(a)(3)(B) – “if such

product is the same product as another product approved under [an ANDA application]” – and

therefore, the question before the Court is whether the agency has advanced a reasonable

interpretation under Chevron step two. FDA asserts that the ambiguous phrase “same product”

can be reasonably interpreted to require that the generic products have not only the same active

ingredients and dosage, but also the same marketing status and location within the Orange Book

as the original drug.

       FDA points out that in 2002, Congress modified the definition of the term “prescription

drug product” under PDUFA to expressly refer to the Orange Book. See 21 U.S.C. § 379g(3)(C)

(2002) (“[a drug] which is on the list of products described in section 355(j)(7)(A) of this title

[(the Orange Book)] . . . .”). The House Conference Report to the Prescription Drug User Fee

Amendments of 2002 (PDUFA III) explains that the modification was made specifically “to

allow the Secretary [of FDA] to use the Prescription Drug Product List (the active portion) in

[the Orange Book] as the basis for identifying which products should be considered to be

prescription drug products for fee assessment purposes.” H.R. Rep. No. 107-481, at 149 (2002)

at 149, reproduced at AR 255. This change was implemented to make the billing process more

efficient and less burdensome on the agency as “[d]etermining eligibility for listing is

administratively complex and sometimes resource intensive.” Id. In 2007, Congress clarified

the matter further by specifying that a “prescription drug product” for which fees would be

assessed is a drug on the list, but “not including the discontinued section of such list.” 21 U.S.C.

§ 379g(3)(C) (2007).




                                                12
       In light of these changes, which directed FDA to look to the Orange Book in its

assessment of fees in one context – the definition of prescription drug product – FDA argues that

it was reasonable for it to decide to refer to the Orange Book in connection with the assessment

of fees in another context: the generic exception. In other words, FDA felt free to define “same

product” to incorporate market status through reference to the Orange Book after 2002, and it

attests that it has consistently interpreted the statute in this manner since 2002. See Letter from

Jane A. Axelrad, Assoc. Dir. For Policy, Ctr. for Drug Evaluation and Research, FDA to David

Jesperson, Vice President of Regulatory Affairs, KV Pharmaceutical Co. (July 10, 2008) (“the

KV Letter”) at 4, reproduced at AR 258–62 (“We have consistently interpreted the statute, since

2002, when PDUFA III changed the method of identifying fee-eligible prescription drug

products, to mean that the product in the Prescription Drug Product List has to be the same as

another product on the Prescription Drug Product List.”). FDA also advances reasons why it

considers its interpretation to be reasonable.

       While the Court accepts FDA’s representation that this has been the agency’s consistent

interpretation since 2002, that is not the predicate issue to be decided. At the outset, the

fundamental issue presented by Count I is whether the Court can make its decision based solely

upon “the unambiguously expressed intent of Congress,” or whether it must defer to the FDA

interpretation. Chevron, 467 U.S. at 842–43. The resolution of this question – the threshold

Chevron determination – depends upon “whether Congress has directly spoken to the precise

question at issue.” Id. at 842.

       The D.C. Circuit has explained:

       Under the first step of Chevron, the reviewing court must first exhaust the
       traditional tools of statutory construction to determine whether Congress has
       spoken to the precise question at issue. The traditional tools include examination
       of the statute's text, legislative history, and structure; as well as its purpose. This

                                                 13
        inquiry using the traditional tools of construction may be characterized as a search
        for the plain meaning of the statute. If this search yields a clear result, then
        Congress has expressed its intention as to the question, and deference is not
        appropriate. If, however, the statute is silent or ambiguous with respect to the
        specific issue, Congress has not spoken clearly, and a permissible agency
        interpretation of the statute merits judicial deference.

Bell Atl. Tel. Co., 131 F.3d at 1047 (internal citations and quotation marks omitted). Thus, the

evaluation of whether Congress’s intent has been made clear is based not just on the text of the

exception, but also the structure of the statute, its purpose, and the legislative history.

        Stat-Trade takes the position that the statute is unambiguous and so the obligation to

defer to the department is not triggered in this case. Looking at the text of the provision, the

Court agrees; the exception plainly applies when there is an approved generic without further

limitation.10

        Furthermore, when looking at the statute, one observes that while Congress expressly

altered the language defining the category of brand-name drugs that were subject to fees, it did

not alter the language defining the category of generic drugs that trigger the exception. It is a

well-recognized canon of statutory interpretation that “[where] Congress includes particular

language in one section of a statute but omits it in another section of the same Act, it is generally

presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion.”

Russello v. United States, 464 U.S. 16, 23 (1983); see also Jama v. Immigration & Customs

Enforcement, 543 U.S. 335, 341 (2005) (“We do not lightly assume that Congress has omitted

from its adopted text requirements that it nonetheless intends to apply, and our reluctance is even




10      This is borne out by the fact that the FDA has announced its intention to ask Congress to
amend the statute to explicitly incorporate the agency’s interpretation. See 76 Fed. Reg. 56,204
(Sept. 12, 2011).


                                                  14
greater when Congress has shown elsewhere in the same statute that it knows how to make such

a requirement manifest.”). 11

       Moreover, the House Conference Report to which the FDA directs the Court’s attention

specifically indicates that the amendment was needed to facilitate the agency’s assessment of

fees, but it says nothing about easing the administration of the exception. Indeed, a candid

sentence in a letter from FDA responding to the only other challenge to FDA’s interpretation of

the generic exception acknowledged that while it may have found keeping track of approved

generics as difficult as cataloguing those “prescription drug products” on which fees could be

assessed, Congress did not expressly address that concern. See KV Letter at 3 (“Although not

noted in the Conference Report, one of the resource intensive, administratively complex issues

included the determination of whether a product was the same as another product that was

withdrawn from marketing.”) (emphasis added). In other words, since 2002, the FDA has

interpreted the generic exception provision to incorporate Congress’s recognition of the

usefulness of the Orange Book, but Congress did not expressly direct it to do that.

       In Serono, the D.C. Circuit provided additional guidance on how to determine whether

the statute is sufficiently clear, and one factor it considered was the fact that the statute did not

specifically define the term at issue in the case. 158 F.3d at 1319. That is the situation in this

case as well. Congress defined “prescription drug product,” for fee-eligibility purposes but it did


11      In fact, Congress directed FDA to consider the Orange Book in several places in the
statute, including in the definition of “prescription drug product,” 21 U.S.C. § 379g(3)(C)
(2002), and in a different exception to product fees contained in the exact same section of
PDUFA as the provision at issue here, 21 U.S.C. § 379h(a)(3)(B) (2002). This provides further
proof that Congress knew how to direct FDA to consult the Orange Book, but chose not to do so
in the generic exception provision. Furthermore, at the time PDUFA was enacted, a provision of
the Federal Food Drug & Cosmetic Act expressly referred to the “commercial marketing” of a
generic drug, as distinct from approval. See 21 U.S.C. § 355(j)(4)(B)(iv)(I) (1992). So not only
did Congress know how to refer to the Orange Book, it also recognized a distinction between
approval and commercial marketing.
                                                 15
not define the terms “approved product” or “same product” that trigger the availability of the

exception. Lacking a definition in the statute, the Serono court went on to consider “what the

terms mean in context.” Id.

       Context is important in this case because while Congress did not expressly define “same

product” in the PDUFA, that phrase already had a distinct meaning in the pharmaceutical

context.   See United States v. Wilson, 290 F.3d 347, 356 (D.C. Cir. 2002) (“Congress is

presumed to preserve, not abrogate, the background understandings against which it legislates.”).

The Federal Food Drug and Cosmetic Act (“FDCA”), which predates the PDUFA, defines a

generic drug, in its ANDA section, as a drug with certain properties that are the “same as” a

brand-name drug. See, e.g., 21 U.S.C. §§ 355(j)(2)(A)(ii), (iii), (v). So it is notable that the

PDUFA generic exception provision at issue here expressly invokes the ANDA section of the

FDCA – it excepts from fees a prescription drug product that is the same product as a product

approved under 21 U.S.C. section 355(j). Furthermore, FDA’s own regulations, in effect at the

time the PDUFA was enacted, use the term “same” to tie a generic drug to its brand-name

counterpart.   FDA regulations from 1983 declare that “[a] finding by the [FDA] that an

abbreviated new drug application is suitable for a drug product applies only to a product that is

the same in active ingredient dosage form and strength, route of administration, and conditions of

use as the drug product that was the subject of the finding.”           Abbreviated New Drug

Applications, 48 Fed. Reg. 2751, 2755 (Jan. 21, 1983). 12 So a consideration of context here



12     The use of the term “same” to describe the relationship between a generic drug and its
brand-name counterpart in FDA’s regulations has only solidified since then. In 1999 – before
the 2002 amendments to the PDUFA – FDA amended its regulations to provide that
“[a]bbreviated applications” are suitable for “drug products that are the same as a listed drug,”
and it defines “same as” as “identical in active ingredient(s), dosage form, strength, route of
administration, and conditions of use . . . .” 21 C.F.R. § 314.92(a)(1) (1999).


                                               16
suggests that the phrase “same product” simply incorporates the ANDA sameness requirement,

and it has nothing to do with whether the generic is in the same section of the Orange Book –

that is, the active list versus the discontinued list – as the original.

        Another appropriate consideration under Chevron step I is the legislative history. There

appears to be only one mention of the exception provision in the entire legislative history of the

PDUFA, and that comes from the report of the House Committee on Energy and Commerce.

H.R. Rep. 102-895 (Sept. 22, 1992). 13          The report states that under the generic exception

provision, “only products not subject to competition from generic drug products will be subject

to the product fee.” Id. at 16. This statement indicates that a concern underlying the provision

was the loss of revenue that the brand name drug faces through competition with generics, and it

may bear on the reasonableness of FDA’s interpretation. But the Court finds that this isolated

comment is not enough to render the plain language of the provision to be ambiguous. While

market status may be one indication of active competition, it is not the indication that Congress

chose to write into law. Rather, it expressly chose to measure competition by the approval status

of the generic.     See also Sanofi-Synthelabo v. Apotex Inc., 488 F. Supp. 2d 317, 342–43

(S.D.N.Y. 2006) (finding irreparable harm based in part on evidence that introduction of a

generic on the market can have irreparable impact on pricing of brand-name drug, even if generic

is later discontinued), aff’d by 470 F.3d 1368, 1382–83 (Fed. Cir. 2006). And where Congress

has chosen particular means of carrying out its policy objectives, FDA may not disregard that



13      The Congressional Record establishes that H.R. 5952 was passed in the House of
Representatives on September 22, 1992. However, due to a filibuster in the Senate, the sponsors
of the PDUFA reintroduced the bill – which was ultimately enacted – as H.R. 6181. H.R. 6181
was identical to H.R. 5952 except for minor Senate amendments, which did not affect the
provision at issue here. In addition, the Committee Report to H.R. 5952, cited above, was
adopted to apply “with equal force to H.R. 6181, as if the House had passed H.R. 5952 with the
Senate amendments.” 138 Cong. Rec. 32,406 (Oct. 5, 1992) (statement of Rep. Waxman).
                                                    17
choice for its own, regardless of whether its preferred choice would also satisfy those objectives.

See Amalgamated Transit Union v. Skinner, 894 F.2d 1362, 1364 (D.C. Cir. 1990) (“Where

Congress prescribes the form in which an agency may exercise its authority, however, [the court]

cannot elevate the goals of an agency’s action, however reasonable, over that prescribed form.”).

        Accordingly, based on an examination of the text, structure, purpose, and legislative

history of the PDUFA, the Court finds that the case must be resolved at Chevron step one. The

generic exception provision contains no gap for FDA to interpret, and applying the plain terms of

the statute, Stat-Trade is entitled to the exception. 14

            B. Stat-Trade’s entitlement to reimbursement of penalties and interest paid for its
               failure to pay 2009–2011 product fees that should have been excepted

        Since the Court has now determined that the 375 and 500 mg strengths of Naprelan are

exempt from product fees, and have been exempt since the generic versions were approved in




14       Even if the Court were to reach Chevron step two and give FDA the deference to which it
is entitled, the Court would reject FDA’s interpretation. While it might be a reasonable policy
choice to limit the availability of the exception to manufacturers facing active competition in the
marketplace, and that might be consistent with the policy underlying the exception, it is not
reasonable to suggest that somehow the term “same product” can be interpreted to include
consideration of that circumstance. Furthermore, FDA’s rationale for the abandonment of its
original interpretation of the provision – that Congress had amended the definition of the term
“prescription drug product” – does not logically lead to the change in policy. The Orange Book
was in publication and contained “active” and “discontinued” sections at the time that the
PDUFA was first enacted, AR 264, and FDA concluded then that the determination of whether a
brand name drug and a generic were the “same product” depends only on whether they share the
“same active ingredient, strength potency, dosage form, and route of administration . . . . The
marketing status of the [generic drug] . . . is not a determining factor. If the [ANDA] has been
approved and not withdrawn, the first approved product [i.e. the brand name drug] is excluded
from fees even if the generic product is not presently marketed.” AR 247. The mere fact that in
2002 Congress decided to allow FDA to look to the Orange Book in a completely different
context cannot reasonably justify FDA’s decision to insert the consideration of market status into
the sameness determination. In addition, since the change was not conducted by notice and
comment rulemaking, but was merely asserted in letters to individual companies, the Court
would not be required to accord FDA full Chevron deference, but only the weaker Skidmore
deference. United States v. Mead Corp., 533 U.S. 218, 234–35 (2001).
                                                   18
2002 and 2003 respectively, the next question is whether Stat-Trade is therefore entitled to

reimbursement of the product fees it paid for fiscal years 2009–2012.

          The first time Stat-Trade contested the assessment of product fees for those two drugs

was in a letter dated April 6, 2011. AR 22–24. FDA views this fact as critical and points the

Court to section 379h(i), which it argues acts as a statute of repose. AR 234–38. That provision

states:

          To qualify for consideration for a waiver or reduction under subsection (d) of this
          section, or for a refund of any fee collected in accordance with subsection (a) of
          this section, a person shall submit to the Secretary a written request for such
          waiver, reduction, or refund not later than 180 days after such fee is due.

21 U.S.C. § 379h(i). Since the contested fees were assessed as product fees under subsection (a)

of section 379h, the Court agrees that Stat-Trade’s failure to submit a written request for a refund

of the fiscal year 2009–2011 product fees within 180 days after the fees were due (March 30,

2010; July 7, 2010; and March 30, 2011 respectively), bars it from reimbursement now.

          Stat-Trade asks the Court to find that the time bar does not apply in this case because: (1)

the product fees were not assessed “in accordance with” subsection (a), but rather, were assessed

in contravention of it, and (2) Stat-Trade could not have sought a “refund” of a fee “collected”

until May 29, 2011, when it actually paid the amount due. 15 But that reading is not compelled by

the text or structure of the statute. First, the Court agrees with defendants that FDA assessed the

fees “in accordance with” subsection (a): FDA derived its authority for assessing the product

fees from that provision, even though this Court has now found its interpretation to be in error.

15      Stat-Trade also argues that the Court should interpret the April 2011 letter as a
supplement to its earlier FEC and BTI waiver requests and on that basis, should find that Stat-
Trade in effect satisfied the statute of repose. But since Stat-Trade did not raise the generic
exception issue in those letters, it cannot claim that those letters satisfy the statute of repose. The
exception request was a new request – not only did it seek a different adjustment amount, but it
was raised under a completely different section of PDUFA than the waiver requests. FDA was
not put on notice of Stat-Trade’s claim to the generic exception until the April 2011 letter.

                                                  19
If this Court were to accept Stat-Trade’s interpretation, then individuals would have an indefinite

period of time to contest any billing mistake, and FDA would never be able to calculate the

amount it collected in fees for any given year with certainty. This would make it nearly

impossible for FDA to assess the balance of fees, costs, and expenses, as it is required to do by

the statute. See 21 U.S.C. §§ 379h(g). 16

       The Court also declines to excuse Stat-Trade from the requirements of the provision

merely because Stat-Trade failed to pay its fees on time. The provision requires that a request –

whether for a waiver or a refund – must be submitted within 180 days of when the fee is due, not

when it is due or paid, whichever comes later. So, Stat-Trade was required to request the

exception within 180 days after the fees were due. Since it failed to do so for fiscal years 2009–

2011, it is not entitled to a refund of those fees now. Similarly, because Stat-Trade failed to

contest those fees within the statutory time limit, it essentially waived its generic exception

claim, and is therefore not entitled to a refund of the penalties, interest, or administrative fees

that arose out of its failure to make timely payments. See United States v. Kubrick, 444 U.S.

111, 117 (1979) (explaining that the elapse of a statute of repose bars the assertion of “stale

claims”).




16     For example, subsection (g)(4) provides:
              If the sum of the cumulative amount of fees collected under this section
              for the fiscal years 2008 through 2010 and the amount of fees estimated to
              be collected under this section for fiscal year 2011 exceeds the cumulative
              amount appropriated under paragraph (3) for the fiscal years 2008 through
              2011, the excess shall be credited to the appropriation account of the Food
              and Drug Administration as provided in paragraph (1), and shall be
              subtracted from the amount of fees that would otherwise be authorized to
              be collected under this section pursuant to appropriation Acts for fiscal
              year 2012.
                                                20
         Accordingly, Stat-Trade is entitled to a refund of the fiscal year 2012 product fees that it

paid for the 375 and 500 mg strengths of Naprelan, but not of the fiscal year 2009–2011 product

fees or the penalties, interest, and administrative fees on the unpaid 2009–2011 fees.

   II.      Count II:     FDA’s delay in considering Stat-Trade’s 2009–2011 FEC waiver
            requests

         Stat-Trade next claims that FDA’s delay in considering the 2009–2011 FEC waiver

requests was arbitrary and capricious in violation of the APA. This claim requires the Court to

consider two distinct questions: First, was it reasonable for FDA to refuse to review Stat-Trade’s

2009 and 2010 FEC waiver requests until Stat-Trade either exhausted or abandoned the appeals

of its BTI waiver request? Second, is it reasonable for FDA to delay its review of Stat-Trade’s

2011 FEC waiver until it can calculate standard costs for that year?

         A. 2009 & 2010 FEC requests: Penalties and interest Stat-Trade paid on fees that would
            have been waived under the FEC waiver had FDA not refused to consider the FEC
            request until Stat-Trade exhausted its appeals on the BTI waiver request

         Stat-Trade claims that it is entitled to a refund of the penalties and interest that accrued on

the fees that would have been waived under the FEC waiver much earlier if FDA had not

conditioned its review of Stat-Trade’s FEC waiver request on Stat-Trade’s exhaustion or

abandonment of its BTI waiver request and appeals. Notably, Stat-Trade’s original complaint

and accompanying motion for preliminary injunction were filed while its requests for a final

determination on its BTI waiver request and all of its original FEC waiver requests were still

pending. See [Dkt. # 1]. At that time, FDA had refused to consider the FEC waiver requests

until Stat-Trade either exhausted or abandoned its appeals of its BTI waiver requests.               Its

rationale for this policy was based on efficiency: since the BTI determination would affect the

amount of the FEC waiver, FDA claimed that it would be inefficient to process the FEC waiver

before there was a final determination on the BTI waiver. Stat-Trade’s original pleadings asked

                                                   21
the Court to find FDA’s delay arbitrary and capricious and to compel FDA to rule. Id. Before

the Court could rule on those motions, however, FDA issued its ruling on the pending FEC

waiver requests for 2009–2010, 17 and granted an FEC waiver of nearly $300,000. [Dkt. # 11].

       Now, Stat-Trade has amended its complaint, and asks this Court to require FDA to refund

the penalties and fees that accrued on the portion of the late FY 2009–2010 payments that should

have been waived under the FEC waivers, and which Stat-Trade finally paid on May 29, 2011.

[Dkt. # 15]. It argues that FDA’s delay in considering those waiver requests was arbitrary and

capricious. Id.

       But Stat-Trade’s claim fails to pinpoint the reason why the penalties and interest were

assessed in the first place: because Stat-Trade did not pay its fees on time. The statute expressly

requires a company to pay its fees within thirty days of the payment deadline, in order to avoid

the fee being “treated as a claim of the United States Government subject to subchapter II of

chapter 37 of Title 31.” 21 U.S.C. § 379h(h). The referenced section of Title 31, in turn, allows

the government to charge penalties and interest on the claim. 31 U.S.C. § 3717. Waiver

requests, by comparison, are not due until 180 days after the fee is due. 21 U.S.C. § 379h(i). So

the statute is structured so that companies must pay the full amount of the fees within 30 days of

the deadline, but may be reimbursed for any waived portion of the fees later, once FDA receives

and processes the waiver request. 18 Regardless of how long FDA takes to process the waiver

requests, the only way that the company avoids penalties is by paying the full amount of its fees



17      FDA declined to rule on the 2011 request because it had not yet calculated standard costs
for the 2011 fiscal year.

18     FDA does have a process for companies to receive some waivers before fees are due if
the company submits its request far in advance of the payment deadline. See AR 226. However,
FDA does not guarantee that it will consider waiver requests before payment is due. Id.
Moreover, the statute does not require FDA to adopt or maintain this policy.
                                                22
on time. So, the reason that Stat-Trade accrued penalties and interest was not FDA’s delay in

processing its waiver requests.

       Since there are no damages attributable to FDA’s delay now that FDA voluntarily

reviewed the waiver requests, this issue is moot and the Court has no jurisdiction to consider the

reasonableness of the delay on the merits. Powell v. McCormack, 395 U.S. 486, 496 n.7 (1969)

(“The rule that this Court lacks jurisdiction to consider the merits of a moot case is a branch of

the constitutional command that the judicial power extends only to cases or controversies.”).

       B. FY 2011 FEC request: FDA’s policy of waiting to consider an FEC waiver request
          until it can calculate standard costs for the applicable fiscal year

       Stat-Trade’s 2011 FEC waiver request, however, is still pending before FDA, so Stat-

Trade’s claim that FDA has unreasonably delayed responding to that request is not moot. Stat-

Trade submitted its 2011 FEC waiver request on September 9, 2010. AR 50. The PDUFA

requires FDA to grant a waiver where “the fees to be paid by such person will exceed the

anticipated present and future costs incurred by the Secretary in conducting the process for the

review of human drug applications for such person.” 21 U.S.C. § 379h(d)(1)(C). FDA stated

that it would not begin to process the waiver until it had sufficient information to calculate

standard costs for fiscal year 2011, which it predicted would be in June 2012 at the earliest. AR

193.

       The statute expressly grants FDA the authority to use “standard costs” in making waiver

determinations. 21 U.S.C. § 379h(d)(3). But since it does not contain a definition of “standard

costs,” FDA has supplied its own consistent interpretation since 1993. AR 185. According to

FDA, it uses a complicated system whereby costs are accumulated in cost centers corresponding

to various organizational components. AR 202. Importantly, its calculation is based in part on

its average costs for the actual fiscal year of the waiver request. AR 202–03. This requires FDA

                                               23
to wait until the close of the fiscal year before it begins to calculate standard costs for that year.

Since waiver applications are submitted before the beginning of the fiscal year, this system

results in a delay of up to two years between when the applicant submits the application and

when FDA processes it. Accordingly, Stat-Trade submitted its 2011 FEC request in September

2010, and as of the time the parties filed their memoranda regarding the cross-motions at issue

here, FDA had not yet processed the request. This, Stat-Trade argues, constitutes “agency action

unlawfully withheld or unreasonably delayed” and is “arbitrary, capricious, an abuse of

discretion, or otherwise not in accordance with the law” in violation of the APA. Second Am.

Compl. ¶¶ 68–70.

       The Court’s role in evaluating a claim of unreasonable delay is to determine “whether the

agency’s delay is so egregious as to warrant mandamus.” Telecomm. Research & Action Ctr. v.

FCC, 750 F.2d 70, 79 (D.C. Cir. 1984) (“TRAC”).          In TRAC, the Court set out six factors that

govern this analysis. Id. at 80. The factors are not “ironclad,” but provide “useful guidance in

assessing claims of agency delay.” Id.; see also In re Core Comms., Inc., 531 F.3d 849, 855

(2009) (explaining the TRAC standard). The first and most important factor is that “the time

agencies take to make decisions must be governed by a ‘rule of reason.’” Core Comms., 531

F.3d at 855, citing TRAC, 750 F.2d at 80. The other five factors are:

       (2) where Congress has provided a timetable or other indication of the speed with
       which it expects the agency to proceed in the enabling statute, that statutory
       scheme may supply content for this rule of reason; (3) delays that might be
       reasonable in the sphere of economic regulation are less tolerable when human
       health and welfare are at stake; (4) the court should consider the effect of
       expediting delayed action on agency activities of a higher or competing priority;
       (5) the court should also take into account the nature and extent of the interests
       prejudiced by delay; and (6) the court need not find any impropriety lurking
       behind agency lassitude in order to hold that agency action is unreasonably
       delayed.

TRAC, 750 F.2d at 80 (internal citations and quotation marks omitted).

                                                 24
       There is no question that FDA has applied a rule of reason here. FDA maintains a

consistent timetable for processing FEC waiver requests, which is based on its method of

calculating standard costs. There is no indication that the processing of Stat-Trade’s 2011 FEC

waiver request will exceed FDA’s regular timetable.

       But Stat-Trade argues that FDA’s method of calculating standard costs, which requires it

to wait until the end of the applicable fiscal year, is inconsistent with the language of the statute.

The statute requires FDA to grant a waiver if it finds that “the fees to be paid by such person will

exceed the anticipated present and future costs incurred by the Secretary . . . .” 21 U.S.C. §

379h(d)(1)(C) (emphasis added). Stat-Trade claims that this use of the future tense means that

the agency must make its determination in advance. But the waiver provision also uses the past

tense: section 379h(d)(1) states that the Secretary shall grant a waiver from or a reduction of the

fees “assessed” if it makes the necessary finding under section 379h(d)(1)(c). In any event, FDA

explains that its method of calculating standard costs does require it to anticipate the present and

future costs; FDA applies the standard costs for all human drug applications submitted in the

fiscal year, regardless of whether its review of the application is actually completed within that

fiscal year or whether it will be completed in the future. AR 187. And, the statute also expressly

permits the agency to utilize standard costs in making the waiver finding. 19

       Although Stat-Trade offers several alternative methods of calculating standard costs that

could be utilized before the end of the fiscal year, the inquiry for the Court is not whether there

are better systems for processing FEC waivers, but whether FDA’s chosen method of responding

to plaintiff’s waiver request is reasonable. Since it is the statute, and not FDA policy, that


19      In its opposition brief, Stat Trade does not actually address FDA’s arguments for why
this claim should be dismissed. But since Stat-Trade does address this issue in its motion for
summary judgment, the Court will incorporate that argument into its opposition and will not treat
the issue as abandoned.
                                                 25
requires waiver applicants to pay their fees before they receive the waiver, the Court cannot find

FDA’s timetable to be unreasonable merely because the upfront payment imposes a burden on

some companies.       Furthermore, FDA offers a reasonable justification for its method of

calculating standard costs. It explains that the main reason it waits until the end of the fiscal year

is so that it knows how many human drug applications each company and its affiliates have

submitted during that year.      This allows it to easily multiply the number of applications

submitted by the standard cost for each kind of application. Accordingly, the Court finds that

FDA’s delay in processing Stat-Trade’s fiscal year 2012 waiver request is not unreasonable,

arbitrary, or capricious.

                                          CONCLUSION

       For the foregoing reasons, the Court will: (1) deny defendants’ motion to dismiss under

Rule 12(b)(6), [Dkt. # 20]; (2) grant in part plaintiff’s motion for summary judgment [Dkt. # 19]

and deny in part defendants’ cross-motion for summary judgment [Dkt. # 20] as to the part of

Count I that relates to product fees for fiscal year 2012; and (3) deny plaintiff’s motion for

summary judgment and grant defendants’ cross-motion for summary judgment as to the

remaining claims. A separate order will issue.




                                                            //s//

                                               AMY BERMAN JACKSON
                                               United States District Judge

DATE: June 25, 2012




                                                 26
