ASTRAZENECA PHARMACEUTICALS LP, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants.
Civil Action No. 12-00472 (BAH)
United States District Court, District of Columbia
July 5, 2012
BERYL A. HOWELL, District Judge.
IV. CONCLUSION
The remaining arguments tendered by the parties are either without merit or need not be reached in light of the basis for the Court‘s decision. Therefore, and for the reasons set forth above, it is, this 3rd day of July, 2012, hereby
ORDERED that Defendants’ [75] Motion for Summary Judgment is DENIED WITHOUT PREJUDICE. Defendants are free to re-raise their arguments concerning the Settlement Agreement in their post-discovery motion for summary judgment, upon further development of the factual record.
SO ORDERED.
Gerald Cooper Kell, U.S. Department of Justice, Washington, DC, for Defendants.
AMENDED MEMORANDUM OPINION
BERYL A. HOWELL, District Judge.
Plaintiff AstraZeneca Pharmaceuticals LP (“AstraZeneca“) has manufactured the drug quetiapine fumarate (“quetiapine“)
AstraZeneca believes that, under the plain language of
Pending before the Court are Cross-Motions for Summary Judgment filed by AstraZeneca, ECF No. 21, and the FDA, ECF No. 26. For the reasons explained below, the Court denies AstraZeneca‘s Motion for Summary Judgment and grants the FDA‘s Motion for Summary Judgment.
I. BACKGROUND1
A. STATUTORY AND REGULATORY BACKGROUND
1. New Drug Applications
The pharmaceutical drug approval process for both new and generic drugs is governed by the FDCA, as amended by, inter alia, the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (“Hatch-Waxman Amendments“) (codified at
Under the FDCA, pharmaceutical drug manufacturers interested in marketing a new pharmaceutical drug (otherwise known as an “innovator” or “pioneer” drug), such as Seroquel, must file a new drug application (“NDA“) with the FDA as required by
The FDA publishes listed drugs in the “Orange Book,” which includes information about applicable patents and periods of exclusivity. See Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, available at http://www.fda.gov/cder/ob/ (“Orange Book“). The Orange Book provides notice to generic drug applicants about when drug patents and periods of exclusivity expire, and when there will be openings to market generic versions of pioneer drugs. See Defs.’ Mem. in Supp. of Mot. for Summ. J. (“Defs.’ Mem.“) at 4.
2. Abbreviated New Drug Applications
The Hatch-Waxman Amendments to the FDCA allowed manufacturers to seek approval from the FDA to market generic drugs by filing an abbreviated new drug application (“ANDA“). See
Prior to 1984, all applicants seeking to market pioneer drugs or generic non-antibiotic drugs had to file [a new drug application (“NDA“)] containing, inter alia, extensive scientific data demonstrating the safety and effectiveness of the drug. See
21 U.S.C. § 355(a) -(b);21 C.F.R. § 314.50 . As a result, few generic non-antibiotic drugs were approved by [the] FDA. See [Glaxo, Inc. v. Heckler, 623 F.Supp. 69, 72 (E.D.N.C.1985)]. Hatch-Waxman created an abbreviated approval process for generic non-antibiotic drugs, while retaining incentives for pioneer drugs, such as marketing exclusivity and patent protections. See21 U.S.C. § 355(j) . The abbreviated new drug application (“ANDA“) process shortens the time and effort needed for approval of a generic drug by allowing the applicant tomerely demonstrate its product‘s bioequivalence to the NDA drug, without reproducing the entirety of the NDA‘s extensive scientific research. See Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 676 (1990) (describing the ANDA process).
ViroPharma, Inc. v. Hamburg, — F.Supp.2d —, —, No. 12-0584, 2012 WL 1388183, at *2, 2012 U.S. Dist. LEXIS 56128, at *6-7 (D.D.C. Apr. 23, 2012) (quoting Allergan, Inc. v. Crawford, 398 F.Supp.2d 13, 16–17 (D.D.C.2005)).
Unlike applicants for pioneer drugs, applicants for generic drugs are not required to submit clinical data to demonstrate the safety and efficacy of their product. Instead, according to the FDA, “if an ANDA applicant establishes that its proposed drug product has the same active ingredient, strength, dosage form, route of administration, labeling (with certain permissible differences), and conditions of use as a listed drug, and that it is bioequivalent to that drug, the applicant” may rely on the FDA‘s earlier findings of safety and efficacy for the drug when it was approved as an NDA. Defs.’ Mem. at 5; see also
FDA-approved generic versions of a drug must utilize the “same” labeling as the labeling approved for the reference-listed drug, except for labeling differences “based on a suitability petition or because the generic drug and the reference drug are produced or distributed by different manufacturers.” Compl. ¶ 35;
3. Exclusivity Periods
Since “Congress still wanted to provide incentives for new drug development, alongside the ANDA process that eased the marketing of generic drugs, Hatch-Waxman entitles an NDA applicant to a period of market exclusivity (3 or 5 years, depending on the degree of innovation reflected in the NDA)....” ViroPharma, — F.Supp.2d at —, 2012 WL 1388183, at *3, 2012 U.S. Dist. LEXIS 56128, at *7 (quoting Allergan, Inc., 398 F.Supp.2d at 17). During an exclusivity period, the FDA is barred from approving a generic ANDA for the NDA product. See id. (citing
Pioneer drugs may also be eligible under statutorily prescribed circumstances for additional periods of exclusivity on the ba-3sis of medical studies completed after the drug approval process. These additional exclusivity periods “provide incentives to pioneer companies to conduct new clinical investigations [for] previously approved NDAs, including through ‘supplemental’ NDAs (‘sNDAs‘).” Compl. ¶ 32 (citation omitted).
The statutory provision at issue in this case,
If a supplement to an application approved under subsection (b) is approved after the date of enactment of this subsection [enacted Sept. 24, 1984] and the supplement contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an [ANDA] ... for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b).
Three-year exclusivity under this statutory provision is sometimes referred to as “new indication exclusivity” or “new patient population exclusivity” because it often applies to applications for approval of the use of an already-approved drug for a new medical indication, such as to treat a different disorder, or a new population of patients, such as a new age group. See Defs.’ Mem. at 6 (citation omitted); ViroPharma, — F.Supp.2d at —, 2012 WL 1388183, at *3, 2012 U.S. Dist. LEXIS 56128, at *8-9. Under FDA regulations, the FDA will not approve an ANDA for three years following the grant of exclusivity to a pioneer drug if the ANDA “relies on ... information supporting a change approved in the supplemental new drug application.”
Under section 355(j)(5)(F)(iv), approval for a new use of a drug must be predicated on new clinical investigations. The FDA defines “new clinical investigation” in its implementing regulation,
According to the FDA, the new indication exclusivity regulation,
The FDA has issued additional regulations on the implementation of
Changes that would not warrant exclusivity are, as discussed in the preamble to the proposed rule, changes in labeling that involve warnings or other similar risk information that must be included in the labeling of generic competitors. Applicants obtaining approval for such changes in labeling would, in any event, have no valid interest in precluding such information from the labeling of other products.
59 Fed.Reg. 50,338, 50,357.
The FDA further noted that it “does not consider a study to be ‘essential to approval’ simply because the applicant conducted it and submitted the study for agency review....” Id. Rather, citing the legislative history, the FDA stated that 3-year exclusivity is reserved for investigations “that are necessary for approval of important 5 innovations,” and require “a considerable investment of time and money.” Id. at 50,358. According to the FDA, “an applicant is not entitled to 3-year exclusivity merely because it supplements an approved application based in part on a clinical investigation or because it certifies to FDA that the clinical investigation is essential to approval of the application or supplement.” Id. In short, the FDA regulations make clear that 3-year exclusivity is not triggered merely by labeling changes related to the safety or risks posed by the drug for indications already approved; such changes, if known, would have been incorporated into the original labeling at the time of the approval of the original NDA. Nor is a 3-year period of exclusivity triggered by the simple submission of new clinical investigations or on the applicant‘s “say-so.”
B. CASE-SPECIFIC BACKGROUND
AstraZeneca developed and now manufactures the drug Seroquel, which was first approved by the FDA as an NDA (NDA 20639) on September 26, 1997. See AR 70-81 (FDA Approval, dated Sept. 26, 1997, of Seroquel, NDA 20639); see also Defs.’ Mem. at 8 (citing Orange Book). Seroquel is an atypical antipsychotic medication that is used to treat a variety of psychological disorders, including schizophrenia and bipolar disorder.6 Although
Since Seroquel‘s approval in 1997, AstraZeneca has filed multiple supplemental applications (“sNDAs“). Based on the approval of those sNDAs, Seroquel has been approved for multiple new medical indications and new patient populations. Although originally used solely for the treatment of schizophrenia, through several sNDAs, Seroquel is now approved for use with the following medical indications and populations: “(1) in adults and adolescents (ages 13 to 17) to treat schizophrenia; (2) in adults, adolescents and children (ages 10 to 17) for the acute treatment of manic episodes associated with bipolar I disorder, both as a monotherapy and as an adjunct to lithium or divalproex; (3) in adults as a monotherapy for the acute treatment of depressive episodes associated with bipolar disorder; and (4) in adults for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex.” Defs.’ Mem. at 9; see AR 66-69 (Orange Book); see also Compl. ¶¶ 21, 42.
AstraZeneca‘s labeling has also changed multiple times since Seroquel‘s original approval. The labeling changes fall into two main categories. First, as the FDA has approved supplements to Seroquel‘s NDA, the newly-approved medical indications and patient populations (“with accompanying three-year exclusivity periods“) have been added to Seroquel‘s labeling. Defs.’ Mem. at 8-9 (citing AR 66-69 (Orange Book)). Second, changes involving new 7 safety information have been made to the labeling. These additional labeling changes, according to the FDA, “have not resulted in exclusivity.” Id.
Atypical antipsychotics, such as Seroquel, may have numerous side effects, including hyperglycemia. To minimize the risk of hyperglycemia in users of atypical antipsychotics, the FDA has investigated the metabolic changes caused by that class of medications. See Compl. ¶ 51. To this end, the FDA has required manufacturers of atypical antipsychotic drugs to provide data and has mandated labeling changes. See id. ¶¶ 50-54. In 2000, the FDA performed a “comprehensive review” of preclinical, clinical, and post-marketing data to see whether atypical antipsychotics disturb glucose regulation. Id. ¶ 51. After reviewing the entire class of atypical antipsychotics, in 2001, the FDA announced that “further study will be needed to elucidate the potential causality of [diabetes mellitus] by” atypical antipsychotics. Id. In September 2003, after years researching the issue, the FDA “mandated a class-wide diabetes/hyperglycemia label change for all atypical antipsychotics,” including Seroquel. Id.
The FDA‘s concern about the effects of atypical antipsychotics on diabetes and hyperglycemia has prompted the agency to require AstraZeneca and other manufacturers continually to update the labels for their atypical antipsychotics with warning information and data that informs prescribers about possible metabolic effects, including glucose shift data.7 Id. ¶ 52. The FDA intended to use the glucose shift data to “create a universal format for presentation of metabolic information in the atyp-
As the FDA considered the metabolic data issue for the entire class of antipsychotic drugs, AstraZeneca continued to market Seroquel and invest in research 8 and development to find new indications, patient populations, and forms of Seroquel. In 2007, the FDA approved a new drug application for Seroquel XR, an extended-release tablet version of Seroquel that only had to be taken once a day, unlike Seroquel, which had to be taken two to three times per day. Compl. ¶¶ 44-45.8
The FDA continued to focus attention on hyperglycemia safety information related to both Seroquel and Seroquel XR and the class of atypical antipsychotics. Although Seroquel already had a label with a general risk statement about hyperglycemia and diabetes, see AR 883, the FDA was interested in displaying more specific hyperglycemia clinical data. In a letter, dated January 8, 2008, the FDA requested that AstraZeneca provide tables of data with summaries of clinical trials related to metabolic parameters for both Seroquel and Seroquel XR. The FDA requested that
On June 26, 2008, in response to the FDA‘s letter requesting tables summarizing metabolic data, AstraZeneca submitted the data to the FDA from which Table 2 was eventually derived, expressly referencing the original NDAs for Seroquel and Seroquel XR. AR 431 (AstraZeneca Letter, dated June 26, 2008, to FDA); see also AR 295 (FDA Letter, dated Mar. 27, 2012, to AstraZeneca); AR 883 (Internal FDA Consultative Review, dated Mar. 27, 2012, to the FDA Office of Generic Drugs (“OGD“), analyzing information in Table 2). In its letter, AstraZeneca noted that the data “follows the criteria as specified in the January 2008 letter, and subsequent clarifications” from the FDA. AR 431. The FDA explains that this data, submitted to the FDA in a letter by AstraZeneca, was “coded by FDA as general correspondence, not as a prior approval supplement (PAS) or a Changes Being Effected (“CBE“) supplement to the Seroquel NDA.” AR 295 (FDA Letter, dated Mar. 27, 2012, to AstraZeneca).
Although the data submitted by AstraZeneca in June 2008 are not part of the Administrative Record,9 the parties do not dispute that this data consisted of fifteen clinical trials, three of which were conducted with Seroquel alone for the treatment of bipolar depression or disorder; two were conducted with both Seroquel and Seroquel XR for schizophrenia; and ten were conducted with Seroquel XR alone, including six trials for the treatment of bipolar disorder and major depressive disorder (“MDD“). AR 309. None of these clinical trials were conducted on pediatric patients or for purposes of generating data for Table 2. AR 301; Defs.’ Mem. at 10. AstraZeneca describes only seven of the trials as “new” because they had not been previously submitted to the FDA. Pl.‘s Mem. at 3 (Statement of Facts, ¶ 4).
Almost four months after submission of the data related to metabolic changes “in Patients Receiving Quetiapine,” AR 431, which led to Table 2, on October 28, 2008, AstraZeneca sought two new pediatric indications for Seroquel by submitting formal supplemental applications, referred to as “S-045” and “S-046,” respectively, for: (1) adolescents (ages 13 to 17) to treat schizophrenia, and (2) adolescents and children (ages 10 to 17) for the acute treatment of manic episodes associated with bipolar I disorder. AR 95. These sNDAs appear to have been the subject of multiple years of study. As early as 2001, AstraZeneca proposed a pediatric study request to the FDA and, in 2003, the agency requested that the results “from trials in pediatric patients with (1) schizophrenia, and with (2) acute mania, as part of bipolar disorder” be submitted within 5 years. See AR 311-24, 312 (FDA Letter, dated Feb. 11, 2003, to AstraZeneca, requesting pediatric clinical trial information and making “[r]eference ... to [AstraZeneca‘s] Proposed Pediatric Study Request submitted on March 2, 2001, to [AstraZeneca‘s] New Drug Application for Seroquel (quetiapine fumarate) tablets.“).
The FDA considered AstraZeneca‘s formal supplemental applications for pediatric indications of Seroquel while simultaneously continuing to refine the labeling of antipsychotic drugs, including Seroquel, with respect to metabolic effects for all approved indications. Until the end of 2008, the FDA and AstraZeneca addressed the sNDAs for the approval of pediatric indications and the class-wide metabolic data separately in their communications. AstraZeneca‘s applications for the pediatric indications, as noted, had been submitted as formal supplements to the Seroquel NDA (an “sNDA“) on October 28, 2008 and AstraZeneca made eleven subsequent submissions particularly regarding the pediatric supplements. See AR 95 (FDA Letter, dated Dec. 2, 2009, to AstraZeneca approving sNDAs 045 and 046 and summarizing submissions relevant to approval). Moreover, in its earlier request for exclusivity for the pediatric indications, AstraZeneca discussed clinical trials it believed were essential to approval, but did not mention Table 2. AR 433-34.
While AstraZeneca and the FDA addressed in the same correspondence multiple pending issues related to Seroquel and Seroquel XR, the agency viewed the labeling changes prompted by metabolic data and the new pediatric indications as distinct and separate issues, which were being considered independently. Nothing in the Administrative Record suggests that the exclusivity periods for which AstraZeneca had applied for the pediatric indications would be extended to include other changes being negotiated between the agency and the pharmaceutical company.
For example, shortly after submission of the sNDAs for the new pediatric indications, the FDA sent a letter, dated December 18, 2008, to AstraZeneca directing the company to include additional data regarding glucose levels in the labeling for Seroquel and Seroquel XR and to “elevat[e]” the data for “glucose changes ... from the clinical trials [from the Adverse Reactions section] to the Warnings/Precautions section of labeling.” AR 11; Pl.‘s Mem. at 16. The FDA further directed AstraZeneca to use the label of another antipsychotic drug, Zyprexa, as a model for the correct formatting of the label. AR 11. The FDA commented that it was “currently reviewing [AstraZeneca‘s] metabolic data submission and the pediatric efficacy supplements submitted under this NDA (S-045 and S-046),” evidently treating them as separate submissions, and noting that the agency would “be providing further labeling comments....” AR 12; see also, e.g., AR 706-09 (FDA Pediatric Exclusivity Determination Checklist, dated Jan. 21, 2009, referring only to the pediatric indications, supplements # 045 and # 046, and not discussing Table 2); AR 710 (AstraZeneca Letter, dated Feb. 12, 2009, to FDA, updating tables with changes in metabolic
On October 16, 2009, the FDA requested that AstraZeneca “[p]lease include a table summarizing the shift changes from normal to high fasting glucose and from borderline to high fasting glucose for the short-term, placebo-controlled clinical trials in adults.” AR 15-19, 18 (FDA Email, dated Oct. 16, 2009, to AstraZeneca, forwarding attachment with labeling changes). The agency also instructed AstraZeneca to “[p]lease refer to current Zyprexa labeling for examples of these tables.” Id. AstraZeneca responded, in a letter on November 18, 2009, stating that it was “providing a response to the proposed label and Medication Guide,” and forwarding an “Amendment to a Pending Application.” AR 1969. As part of this submission, AstraZeneca included draft labeling for Seroquel that included not only metabolic data in Table 2 but also referred to many other labeling changes. Tellingly, in track changes, the FDA referred to labeling changes in connection with multiple pending applications, not just sNDAs 045 and 046, the supplemental applications for the pediatric indications. See AR 1973 (Apparent FDA note in draft labeling referring to “your labeling changes submitted under S-042, 044, 045, 046 and 048. In this version, we have made additional modifications in several sections. We have included bracketed comments to note these changes or request additional revisions where needed.“). Thus, it appears that the FDA was communicating with AstraZeneca about numerous proposed changes all at once, with no suggestion that exclusivity was at stake for all of the many changes proposed in track changes in the draft label.
As noted, one of the many proposed changes in the draft label was Table 2. See AR 1991. Next to Table 2, AstraZeneca noted that it “[a]dded table summarizing the shift changes from normal to high fasting glucose and from borderline to high fasting glucose as requested by FDA in the 10/16/09 FDA communication.” Id. The “Source” of Table 2 is listed as “NDA 20-639, Metabolic Response, submitted 26 June 2008, Table # 339.” Id. Thus, the November 2009 draft labeling proposal from AstraZeneca demonstrates that the addition of Table 2 was derived from its submission to the FDA on June 26, 2008, almost four months before it submitted
Less than a month after AstraZeneca transmitted to the FDA track changes in the proposed labeling, the FDA approved, on December 2, 2009, the pediatric supplemental applications for Seroquel as well as AstraZeneca‘s proposed labeling changes, including the addition of Table 2. AR 95-99 (FDA Letter, dated Dec. 2, 2009, to AstraZeneca, approving supplemental new drug applications for pediatric indications) (“Approval Letter“). The FDA‘s decision to approve Table 2 for inclusion in the labeling and its decision to approve the pediatric indications for Seroquel were two separate actions. See id. The FDA, however, communicated its decisions to approve both the display of class-wide safety information, including Table 2, and the approval of the pediatric sNDAs in the same letter. Id.
The Approval Letter primarily focused on the approval of the two pediatric sNDAs, for which AstraZeneca earned 3 years of exclusivity, stating that:
These supplemental new drug applications provide for the use of Seroquel (quetiapine fumarate) tablets for the treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age. We have completed our review of these applications. They are approved....
AR 95.
The Approval Letter also noted, however, that the supplemental drug applications “are approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.” Id. (emphasis added). The letter directed that the content of the labeling shall be formatted in structured product labeling (SPL) format and “[f]or administrative purposes ... designate[d] [as] ‘SPL for approved NDA 020639/S-045/S-046.‘” AR 95-96.
In a separate section of the Approval Letter, captioned “Risk Evaluation and Mitigation Strategy Requirements,” the FDA explained that “[s]ince Seroquel (quetiapine fumarate) was approved on September 26, 1997, [the FDA has] become aware of additional clinical trial data and postmarketing safety data that show a risk of hyperglycemia, hyperlipidemia and weight gain associated with all forms of Seroquel (quetiapine fumarate) in all patient populations. [The FDA considers] this information [in Table 2] to be ‘new safety information’ as defined in section 505-1(b) of FDCA.” AR 96 (Approval Letter). Immediately following that statement, the letter states that AstraZeneca‘s proposed REMS (Risk Evaluation and Mitigation Strategy), “submitted on October 22, 2009 ... is approved.” Id. Attached to the Approval Letter is the approved labeling showing Table 2 in the “Adults” rather than the “Children and Adolescents” section of the document. AR 112–13.
Although the FDA expressed approval for both the new pediatric uses and the Table 2 labeling change in a single letter, each change was approved on its own merit. The FDA notes that it “consolidated a number of ... actions” referred to in the approval letters sent to AstraZeneca for the two new pediatric indications (S-45, S-46). See AR 295 n. 9 (FDA Letter, dated March 27, 2012, to AstraZeneca). Support for this assertion is found, inter alia, in an internal FDA Memorandum, noting that “the addition of Table 2 was not related to approval of these new indications. It is not unusual for DPP [the Division of Psychiatry Products] to bundle actions together.... [M]odifications to product labeling usually occur in concert with other actions being taken.” AR 883 (Internal FDA Con-
The FDA‘s communications following the December 2, 2009 approval of the pediatric indications and proposed labeling only reinforce that the addition of Table 2 was a decision distinct from the decision to grant the sNDAs for pediatric indications and related exclusivity, and was part of the agency‘s broader efforts with respect to the provision of safety information related to the metabolic effects of atypical antipsychotics. In an email from the FDA to AstraZeneca, on July 22, 2011, for example, the FDA explained that the agency “has been working with sponsors class-wide to create a universal format for presentation of metabolic information in the atypical package insert labels.” AR 21 (Email from FDA, dated July 22, 2011, to AstraZeneca). The FDA referenced AstraZeneca‘s pending supplements (NDA 20639, S-053, NDA 22047, S-026) and requested that AstraZeneca “please submit revised labeling to these supplements that incorporates this new format-Hyperglycemia, and Diabetes Mellitus/Dyslipidemia/Weight Gain as separate headings under one warnings and precaution section, with the same introductory paragraph preceding the headings, as in the Latuda/Invega labels.” Id. Thus, the FDA‘s efforts to improve metabolic data in the labeling of atypical antipsychotics continued, apart from the indications for which AstraZeneca was granted exclusivity on December 2, 2009.
The crux of the instant dispute is that AstraZeneca believes that it is entitled to a 3-year period of exclusivity for use of Table 2 in Seroquel labeling because Table 2 was a change based on clinical trials approved as part of a supplemental application. AstraZeneca contends that the FDA‘s approval of ANDAs for generic versions of Seroquel violates its right to exclusive use of the labeling, and was arbitrary, capricious, and contrary to law. The FDA does not dispute that Table 2 is essential information for all quetiapine labels, but believes that Table 2 is not entitled to exclusivity in part because it was not “essential” to approval of the pediatric supplement under
C. PROCEDURAL BACKGROUND
Under
The FDA denied AstraZeneca‘s Citizen Petitions “without comment” on March 7,
The FDA conveniently conflated the legal issues raised by the Citizen Petitions: namely, (1) whether the agency would approve ANDAs for generic versions of Seroquel without the identical labeling re-12quired to be used by AstraZeneca, and (2) whether the agency concurred in AstraZeneca‘s legal judgment that Table 2 was derived from “protected data” that was subject to exclusivity periods, which did not expire until December 2, 2012. While the former issue was dependent upon the specific ANDA application pending before the FDA, the second issue could have been addressed even if no ANDA were ever approved.
Less than one week later, following the FDA‘s denial of AstraZeneca‘s Citizen Petitions, AstraZeneca filed a Complaint together with a Motion for a Preliminary Injunction in the District Court for the District of Columbia. AstraZeneca sought to prevent the FDA from granting final approval to ANDAs to manufacture generic forms of Seroquel. See AstraZeneca Pharms. LP v. FDA, 850 F.Supp.2d 230 (D.D.C.2012). The case was assigned to another Judge on this court and, on March 12, 2012, that Judge denied the Motion for Preliminary Injunction and dismissed the case as unripe because the FDA had not yet decided to grant approval to any ANDA for a generic version of Seroquel. See id. at 250, at *55-56.
Only four days after AstraZeneca‘s case was dismissed, on March 27, 2012, the FDA granted final approval to eleven ANDAs for generic versions of Seroquel. Pl.‘s Mem. at 3 ¶ 6; Compl. ¶ 11; Defs.’
In sum, FDA concurs that these portions of the labeling [including Table 2] are essential to safe use of a generic quetiapine product referencing Seroquel for any indication, and the agency would not approve a quetiapine ANDA referencing Seroquel that omitted them. FDA does not concur, however, that an ANDA referencing Seroquel is precluded from including Table 2 or the suicidality warnings by virtue of AstraZeneca‘s 3-year exclusivity on certain indications for Seroquel XR.
AR 305-06 (FDA letter, dated Mar. 27, 2012, to AstraZeneca). The FDA provided several explanations for finding that Table 2 was not protected by a period of exclusivity, including, inter alia, (1) that the data was not specific to any indication and generally changes in labeling that involve the addition of warnings are not entitled to 3-year exclusivity; (2) Table 2 does not include data from indications for which Seroquel has 3-year exclusivity and does not include any pediatric data; and (3) the “coincidental” timing of the addition of Table 2 being approved at the same time as the pediatric supplements does not mean that the labeling change merits a period of exclusivity. See AR 301-03.
This Court denied Plaintiff‘s motion for a Temporary Restraining Order on March 28, 2012, finding that AstraZeneca had not shown a likelihood of success on the merits. See AstraZeneca Pharms. LP v. FDA, No. 12-472, 2012 WL 1037457, at *2-3, 2012 U.S. Dist. LEXIS 54863, at *7-10 (D.D.C. Mar. 28, 2012).13 Following this Court‘s denial of AstraZeneca‘s Motion for a Temporary Restraining Order, the parties supplemented the Administrative Record and briefed the pending Cross-Motions for Summary Judgment.14 The parties’ Cross-Motions for Summary Judgment are now before this Court.
II. STANDARD OF REVIEW
A. SUMMARY JUDGMENT
Pursuant to
In ruling on a motion for summary judgment, the Court must draw all justifiable inferences in favor of the nonmoving party, and shall accept the nonmoving party‘s evidence as true. Anderson, 477 U.S. at 255; Estate of Parsons, 651 F.3d at 123; Tao, 27 F.3d at 638. The Court is only required to consider the materials explicitly cited by the parties, but may on its own accord consider “other materials in the record.”
B. ADMINISTRATIVE PROCEDURE ACT
Under the Administrative Procedure Act (“APA“), the reviewing Court must set aside those agency actions that are in excess of an agency‘s statutory jurisdiction, authority, or limitations.
In Chevron Step One, the Court first asks whether “Congress has directly spoken to the precise question at issue.” Bhd. of R.R. Signalmen v. Surface Transp. Bd., 638 F.3d 807, 811 (D.C.Cir. 2011) (quoting Chevron, 467 U.S. at 842). If so, the Court “must give effect to the unambiguously expressed intent of Congress.” Id. (quoting Chevron, 467 U.S. at 843). In deciding whether a statute is ambiguous, the Court has “a duty to conduct an ‘independent examination’ of the statute in question.” Martini v. Fed. Nat‘l Mortg. Ass‘n, 178 F.3d 1336, 1345 (D.C.Cir.1999) (citation omitted).
“If Congress has not directly addressed the precise question at issue, the reviewing court proceeds to Chevron Step Two.” Ass‘n of Private Sector Colls. & Univs. v. Duncan, 681 F.3d 427, 441 (D.C.Cir.2012) (quoting HARRY T. EDWARDS & LINDA A. ELLIOTT, FEDERAL STANDARDS OF REVIEW—REVIEW OF DISTRICT COURT DECI-
III. DISCUSSION
AstraZeneca contends that the FDA‘s final approval of generic versions of Seroquel was in contravention of
AstraZeneca argues in support of its Motion for Summary Judgment that the FDA‘s approval of the ANDAs was unlawful, for two distinct reasons based on the plain and unambiguous language of
As explained above, the threshold question is whether the statute is ambiguous, or instead, by its plain terms, compels the result urged by AstraZeneca. If the statute is ambiguous, then the Court must defer to the FDA‘s determination, which was well within the agency‘s expertise, so long as its decision was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. See, e.g., ViroPharma, Inc., — F.Supp.2d at —, 2012 WL 1388183, at *11, 2012 U.S. Dist. LEXIS 56128, at *37 (“It bears emphasis that [i]n an area as complex as the regulatory system for pharmaceuticals, the agency Congress vests with administrative responsibility must be able to exercise its authority to meet changing conditions and new problems.“) (citations and internal quotation marks omitted and alteration in original). Upon review of the administrative record, and for the reasons explained below, the Court concludes that
A. CHEVRON STEP ONE
Under Chevron Step One, “[f]irst, always, is the question whether Congress has directly spoken to the precise question at issue. 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.” Chevron, 467 U.S. at 842-43; see also NRDC v. EPA, 643 F.3d 311, 322 (D.C.Cir.2011) (“We begin with the statute.“). As noted, the relevant provision of the FDCA subject to this Court‘s statutory interpretation and Chevron analysis, and at the heart of the dispute, is
AstraZeneca‘s position is that the Court‘s analysis should end at Chevron Step One because the plain language of
The FDA, on the other hand, has interpreted the statutory provision at issue as requiring a relationship between the subject of the “new clinical investigations,” the change to the product or use of the product, and the scope of the three-year exclusivity, explaining as follows:
The statute sets up a relationship between the “new clinical investigations” that are “essential to the approval of the supplement,” and the scope of the exclusivity. That is, if an applicant submits a supplement and gets 3-year exclusivity for a change in the use of the drug product supported by new clinical investigations, the FDA may not approve an ANDA referencing that drug product for the “change approved in the supplement” during that 3-year exclusivity period. Because the change in the drug product or use of the drug product that was approved in the supplement was based at least in part on the new clinical investigations, it naturally follows that the scope of any exclusivity also will relate to the scope of those new clinical investigations.
AR 299 (FDA Letter, dated Mar. 27, 2012, to AstraZeneca).
Although the FDA, in its briefs, framed its argument as a “reasonable interpretation” of the statute, the Court believes that the FDA‘s interpretation is closest to the plain meaning of the statute. Indeed, the Court agrees with the FDA that the statute sets up a “logical relationship between the change in the product for which the new clinical investigations were essential to approval of the supplement, and the scope of any resulting three-year exclusivity.” Defs.’ Reply at 3-4. Interpreting the plain meaning of the statute in this way means that only changes to labeling derived from clinical studies related to the changes approved in the supplement may be entitled to exclusivity. See id. at 3-4. Thus, AstraZeneca is not automatically entitled to exclusivity for Table 2 by virtue of unrelated clinical studies supporting the pediatric indications approved on December 2, 2009.
AstraZeneca also argues, however, that Table 2 deserves exclusivity on its own merit, independent of the pediatric supplements. See Pl.‘s Mem. at 17.
Although the statute‘s plain meaning favors the FDA, since plausible plain meaning arguments cut both ways, the Court believes the better reading of the statute is that
First, the Court turns to the phrase “new clinical investigation.” It is an established principle of statutory construction that a provision‘s context should be used to assist in determining whether a statute commands a certain interpretation or has a plain meaning. See, e.g., Samantar v. Yousuf, — U.S. —, 130 S.Ct. 2278, 2289, 176 L.Ed.2d 1047 (2010) (“[W]e do not construe statutory phrases in isolation; we read statutes as a whole.“) (quoting United States v. Morton, 467 U.S. 822, 828, 104 S.Ct. 2769, 81 L.Ed.2d 680 (1984)); see also Dolan v. U.S. Postal Serv., 546 U.S. 481, 486, 126 S.Ct. 1252, 163 L.Ed.2d 1079 (2006) (“Interpretation of a word or phrase depends upon reading the whole statutory text, considering the purpose and context of the statute[.]“). In the context of this provision, the meaning of “new clinical investigation” is not “plain.” It is not immediately apparent that AstraZeneca‘s clinical studies underlying Table 2 are “new clinical investigations” for purposes of the statute. In 2008, AstraZeneca submitted to the FDA the clinical studies that are the basis for Table 2 in AstraZeneca‘s unrelated effort
Second, the phrase “essential to approval” is ambiguous. Congress provides no guidance or criteria under which reports of new clinical investigations may be judged “essential” versus merely persuasive or noteworthy. See Upjohn Co. v. Kessler, 938 F.Supp. 439, 444 (W.D. Mich. 1996) (noting that a determination of what data is “essential to approval” is “squarely within the ambit of the FDA‘s expertise and merit[s] deference ...“) (citations and internal quotation marks removed). Furthermore, AstraZeneca seems to interpret the FDA‘s judgment that Table 2 contains essential safety data as automatically making Table 2 “essential to approval” of the supplement containing unrelated pediatric data for new pediatric indications. See Pl.‘s Mem. at 2. The words of the statute cannot bear this overbroad interpretation.
Third, AstraZeneca argues that the plain meaning of the phrase “a change approved in the supplement” means that any change approved in the supplement is entitled to exclusivity. See Pl.‘s Mem. at 8. The clear implication of this reading is that any change approved in the supplement, whether or not it is related to the “new clinical investigation,” or to the new uses approved in the supplement, is entitled to exclusivity. See id. AstraZeneca argues that this reading is compelled by Congress‘s use of the phrase “a change” rather than “the change.” See id. This reading is unpersuasive for two reasons. First, it is not unusual for supplements to contain more than one change. See Defs.’ Mem. at 23-24. By its use of “a” rather than “the,” Congress provided the flexibility for the FDA to approve multiple changes within one supplement, rather than requiring a separate supplement for each change. Second, AstraZeneca‘s interpretation ignores the implication of the phrase “in the supplement.” As noted, the most plausible meaning is that there must be a connection between the change and the supplement beyond mere coincidence of appearing in the same approval letter. See id. at 24. Congress could not have intended that the FDA‘s decision to report on completely unrelated regulatory actions in the same letter for the sake of efficiency would confer on drug manufacturers additional periods of exclusivity when that exclusivity was not otherwise merited. Thus, even if this phrase has a plain meaning, it favors the FDA rather than AstraZeneca. At the very least, however, this phrase is ambiguous.17
Finally, the subsection read as a whole is ambiguous. AstraZeneca proposes one interpretation that goes thusly: (1) Any change to a pioneer drug application
While AstraZeneca is correct that “an agency‘s own regulations cannot create or give rise to ambiguity when the statutory language is unambiguous[,]” Pl.‘s Reply at 6 (citing Chevron, 467 U.S. at 843 n. 9, 104 S.Ct. 2778 (“The judiciary is the final authority on issues of statutory construction and must reject administrative constructions which are contrary to clear congressional intent.“)), in this case the parties’ different interpretations of the statutory provision highlight the statute‘s ambiguity.
Accordingly, the Court proceeds to Chevron Step Two.
B. CHEVRON STEP TWO
As this Court found in denying AstraZeneca a Temporary Restraining Order, the FDA has reasonably interpreted
1. The Administrative Record Shows that the Pediatric Supplements Were Approved on Their Own Merit, and Table 2 Standing Alone Does Not Entitle AstraZeneca to Exclusivity.
AstraZeneca posits two bases for exclusivity for Table 2 arising from two separate sets of clinical investigations: the clinical investigations supporting pediatric indications and the clinical investigations that yielded the data for Table 2. According to AstraZeneca, “each separately and independently establishes AstraZeneca‘s exclusivity rights under the plain, unambiguous language of the statute.” Pl.‘s Reply at 3. Since the Court finds the statute to be ambiguous, however, analysis of these two arguments turns on whether the FDA‘s interpretation of the statute was reasonable, as explained below. See Chevron, 467 U.S. at 843, 104 S.Ct. 2778.
a. Clinical Investigations Supporting Pediatric Indications Do Not Support Exclusivity For Table 2.
The administrative record shows that the pediatric supplements approved on December 2, 2009 were approved on their own merit, and the addition of Table 2 was not a factor in the evaluation of the safety and efficacy of Seroquel for pedia-
While AstraZeneca states repeatedly that “the addition of Table 2 to the label was part of the supplements approved on December 2, 2009,” see, e.g., Pl.‘s Reply at 20-21, AstraZeneca has not established that the approval of Table 2 was essential to the approval of the pediatric sNDAs, which were supported by entirely different clinical trials. None of AstraZeneca‘s citations to the Administrative Record show that the FDA mandated changes to Table 2 “as a condition of approval of the sNDAs.” Pl.‘s Reply at 1; see also Pl.‘s Mem. at 16. An example of evidence that conceivably supports AstraZeneca‘s position in the Administrative Record is an internal FDA Memorandum, dated August 13, 2009. See AR 853-64. In the memorandum, an FDA official stated that, “[w]e should be negotiating labeling changes with the sponsor prior to approval of these NDA supplements” and “I recommend the Division should consider approval of this set of NDA supplements provided that an agreement is reached between the sponsor [AstraZeneca] and the Agency regarding the language in the labeling.” Id. at 863-64. Since Table 2 was not related to the pediatric supplements, however, which were approved on their own merit, this internal recommendation, without more, does not render Table 2 “essential to approval” of the pediatric supplements.
Moreover, the fact that the FDA said it would not approve generics without Table 2 does not mean that it would not have approved the pediatric indications for Seroquel without Table 2. Indeed, it appears to the Court that the addition of Table 2 merely coincided with, but was not essential to, the sNDA approvals on December 2, 2009. See AR 303 (FDA Letter, dated Mar. 27, 2012, to AstraZeneca, stating that “[t]his data does not qualify for any protection solely by virtue of the timing of FDA‘s approval of the supplement, including Table 2. Rather, the scope of exclusivity must relate to the new clinical investigations that were conducted.“); AR 883 (Internal FDA Consultative Review, dated Mar. 27, 2012, noting that “the addition of Table 2 was not related to approval of these new [pediatric] indications. It is not unusual for [the Division of Psychiatry Products] to bundle actions together—modifications to product labeling usually occur in concert with other actions being taken.“).
As the FDA notes, AstraZeneca‘s reliance on approval of the pediatric indications to support a period of exclusivity for the unrelated addition of Table 2 seems to be an attempt “to bootstrap AstraZeneca‘s exclusivity for the pediatric indications into exclusivity for Table 2 because those separate changes were approved at the same time.” Defs.’ Mem. at 21. The FDA, however, has reasonably construed the phrase “a change approved in the supplement” to mean “a change relating to ‘new clinical investigations.‘” Id. at 24; see also Univ. Med. Ctr., Inc., 856 F.Supp.2d at 78 (finding that the agency‘s “construction of a statute ... need not be the best or most natural one.... Rather [it] need be only reasonable to warrant deference.“) (citations and internal quotation marks omitted). “[T]he FDA was within its discretion to apply a limiting principle so that Hatch-Waxman‘s exclusivity provisions do not apply to all approved changes that are ‘new‘.... [T]he general exclusivity period provided in
b. Clinical Investigations From Which Table 2 Is Derived Are Not A Basis For Exclusivity.
AstraZeneca also argues that it is entitled to exclusivity for Table 2 because the FDA had not previously relied on seven of the fifteen clinical investigations from which Table 2 was derived. See Pl.‘s Reply at 18-19. This argument is unpersuasive for two reasons. First, it it seems to depend on the assumption that Table 2 was approved as a formal “supplement.” The FDA has made clear, however, that the approval of Table 2 was merely coincidental to the approval of the pediatric indication supplements approved in December 2009, and that “Table 2 was not submitted pursuant to a supplement.” Defs.’ Mem. at 31.
Second, examining Table 2 separately from its coincidental inclusion with the pediatric supplement, the FDA‘s interpretation that Table 2 is not entitled to independent exclusivity is reasonable. The FDA‘s interpretation of the statute as only granting exclusivity for significant innovations is reasonable given the statute‘s careful balance between providing exclusivity rights to promote innovation and making generic alternatives available to patients. See Defs.’ Mem. at 33-34; Defs.’ Reply at 15; see also Upjohn Co., 938 F.Supp. at 441 (citing Abbott Labs. v. Young, 920 F.2d 984, 985 (D.C. Cir. 1990)) (“At the same time that it expedited approval of generic drugs, Congress recognized the need to protect the interests of the original drug manufacturers and to provide incentives for the invention of new products.“). The FDA‘s reading of the statutory provision is also reasonable given that the provision itself tethers the “change” approved in the supplement to subsection (b), and thereby imparts to the meaning of a formal supplement that it mark a sufficiently significant change that would have warranted an additional use or indication of the drug if it had been submitted with the original NDA under subsection (b). See
AstraZeneca‘s interpretation, by contrast, “would effectively provide for whole-product exclusivity whenever FDA determined that data from a clinical trial would have relevance to the safety of the product for all indications, even if the data were insufficient to support approval (and exclusivity) for a new indication.” Defs.’ Mem. at 35. Accordingly, it is reasonable for the FDA not to grant exclusivity here because
2. The FDA Did Not Act Arbitrarily or Capriciously.
The FDA‘s interpretation of the statute is consistent with its past practice.18 The FDA has emphasized that generally applicable safety information in labeling should not be subject to exclusivity. See Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions, 59 Fed.Reg. 50,338, 50,357 (Oct. 3, 1994) (Supplementary Information Accompanying Final Rule, dated Oct. 3, 1994, noting that innovators have “no valid interest in precluding such information from the labeling of other products“). While the FDA declined in its final implementing regulations to define the nature of supplemental applications, which, “if supported
Notably, the FDA has also denied exclusivity for similar labeling changes to other drugs in Seroquel‘s class of antipsychotics. See AR 303 n. 21 (FDA Letter, dated Mar. 27, 2012, to AstraZeneca, stating that “[t]he agency‘s conclusion that Table 2 is not protected and its implications for generic quetiapine products is consistent with the agency‘s treatment of other second-generation antipsychotics for which data regarding metabolic changes, including Table-2 like data, have been made.“). According to the FDA, in fact, “[s]even drugs [in the same antipsychotic class as Seroquel] (Invega, Invega Sustenna, Abilify, Risperdal, Risperdal Consta, Fanapt, and Latuda) have included class-wide labeling changes for metabolic data, and none of them has received exclusivity for those changes.” Defs.’ Mem. at 36 n. 22.
AstraZeneca cites the FDA‘s handling of four drugs (Meridia, Travatan, Rapamune, and Colcrys) as examples to support the
In the case of Meridia, according to the FDA, the labeling change for which exclusivity was granted was “substantively related to the new clinical investigations that were essential to the approval of a clinical efficacy supplement.” Defs.’ Reply at 16; see also Defs.’ Mem. at 37-38. Similarly, in the case of Travatan, the FDA granted exclusivity to a labeling change on the basis of clinical data that “expanded the patient population” by replacing a statement that Travatan had not been studied in patients with renal or hepatic impairment with clinical findings showing that “no clinically relevant changes were observed” when those patients took the drug. Defs.’ Mem. at 38.
In the cases of Rapamune and Colcrys, information that was originally used to support new efficacy supplements was also considered necessary safety labeling information. With respect to Rapamune, the FDA determined that Rapamune was entitled to exclusivity for “a clinical efficacy supplement for cyclosporine withdrawal procedures in patients at low to moderate risk for rejection.” Defs.’ Mem. at 39 (citation omitted). The FDA concluded, however, that the labeling information exclusivity should be extended to the population at high risk of rejection because that “labeling information might help raise physicians’ awareness of the risks of cyclosporine.” Declaration of Benjamin C. Block (“Block Decl.“), ECF No. 21, Ex. 2 (quoted in Defs.’ Mem. at 39). Likewise, for Colcrys, 3-year exclusivity was originally granted to dosing information essential to treating acute gout flares. AR 957 (FDA Letter, dated May 25, 2011, to Sidley Austin LLP regarding the approval of Colcrys). When the FDA concluded that the same dosing information was necessary for the related indication of prophylaxis of gout flares, exclusivity was granted to the prophylaxis indication, even though it was previously not protected. See id. at 977; Defs.’ Mem. at 39.
The critical difference in circumstances between the protected labeling information for the drugs Rapamune and Colcrys and unprotected Table 2 for Seroquel is that, in the cases of the former drugs, the labeling changes were tied to the approval of efficacy supplements, whereas the approval of Table 2 was never essential to the approval of any efficacy supplement for Seroquel. See, e.g., AR 11-12 (FDA Letter, dated Dec. 18, 2008, to AstraZeneca, making clear that metabolic data submissions, which led to creation of Table 2, are separate from the pediatric efficacy supplements under consideration). Table 2 did not contribute to the approval of the pediatric or any other efficacy supplement, and has not yet led to any other changes in efficacy, such as a new dosage or prescribing regimen or a new indication or use in a new patient population. In other words, if the safety data reflected in Table 2 had been known at the time of the FDA‘s approval of the Seroquel NDA for its original indications, it would have been included in the original labeling. Thus, although the FDA considers Table 2 “essential”
Furthermore, the FDA provided a reasoned explanation for its decision to approve ANDAs for generic versions of Seroquel. On March 27, 2012, the FDA issued a seventeen-page letter to AstraZeneca explaining the agency‘s rationale for finding that Table 2 in Seroquel was not protected by a three-year exclusivity period. See AR 293-310; see also Defs.’ Mem. at 12-13. Since this letter explains, inter alia, that generally-applicable safety information of the type in Table 2 is not subject to protection, the agency‘s decision to deny Table 2 exclusivity is not arbitrary and capricious. See Motor Vehicle Mfrs. Ass‘n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983) (quoting Burlington Truck Lines v. United States, 371 U.S. 156, 168, 83 S.Ct. 239, 9 L.Ed.2d 207 (1962), for the proposition that “the agency must examine the relevant data and articulate a satisfactory explanation for its action including a ‘rational connection between the facts found and the choice made.‘“).
Therefore, because the FDA provided a reasoned explanation for its decision, the FDA‘s decision to deny AstraZeneca exclusivity for Table 2 was not arbitrary and capricious.
The potential implications of AstraZeneca‘s broad reading of the statute also lend support to the FDA‘s interpretation. As noted, the FDA has undertaken an effort to implement updated safety labeling for drugs in the same class as Seroquel with metabolic data similar to what is displayed in Table 2. Defs.’ Reply at 11. AstraZeneca‘s interpretation of this statutory provision would seriously impede the FDA‘s initiative to improve the safety data available for this class of drugs, which includes Invega, Invega Sustenna, Abilify, Risperdal, Risperdal Consta, Fanapt, and Latuda.19 Id. Though all of the safety data added to the labels of these drugs is derived from clinical investigations, the FDA claims that none of these investigations provided the basis for three-year exclusivity. Id.; see also AR 303-04 n. 21 (FDA Letter, dated Mar. 27, 2012, to AstraZeneca). A reading of the statutory provision at issue that could prevent the FDA from requesting from drug manufacturers any class-wide safety labeling changes involving clinical trials without triggering exclusivity periods is untenable and, as detailed below, plainly inconsistent with the legislative history.
3. The FDA‘s Interpretation of the Statute is Consistent with Legislative History.
The Court finds the FDA‘s interpretation of the statute consistent with the statute‘s legislative history. As noted, a central purpose of the Hatch-Waxman Amendments, as reflected in its title “The Drug Price Competition and Patent Term Restoration Act,” was to promote competi-
Congress had dual purposes, however, and enacted the abbreviated approval process for generic drugs while simultaneously retaining incentives, such as marketing exclusivity, to encourage innovation and development from pioneer drugmakers. See
While AstraZeneca is thus correct to point out that Congress provided exclusivity rights “as an incentive for pioneer companies to engage in expensive clinical research,” Pl.‘s Reply at 1, granting exclusivity to Table 2 would disrupt the “careful balance” Congress crafted. Adopting AstraZeneca‘s interpretation, where every change approved in a supplemental application receives exclusivity, would increase the potential for companies to receive whole-product exclusivity and bar generic competition altogether for labeling changes unrelated to innovations in drug use. See Defs.’ Mem. at 36. As the FDA notes, AstraZeneca‘s interpretation would result in an “unwarranted evergreening of exclusivity,” Defs.’ Reply at 10, allowing AstraZeneca to retain a monopoly over production of a drug by periodically updating safety information in their labeling. This risk is particularly worrisome given the FDA‘s practice that “modifications to product labeling usually occur in concert with other [regulatory] actions being taken.” AR 883 (FDA Consultative Review, dated Mar. 27, 2012, to OGD). AstraZeneca‘s interpretation would create a perverse incentive for pharmaceutical companies to drag out their presentation of vital safety data to the FDA in order to bar generic competition beyond the periods determined acceptable by Congress. While Congress was no doubt concerned that pharmaceutical manufacturers have incentives to continue research and development in order to discover vital new drugs, Congress plainly did not intend for these manufacturers to retain exclusivity into perpetuity.
The legislative history makes clear that the sponsors of the Hatch-Waxman Amendments, Senator Orrin Hatch and Representative Henry Waxman, envisioned that three-year exclusivity would be granted for significant changes, such as approvals for new therapeutic uses and
The legislative history thus supports the FDA‘s reasonable conclusion that Table 2 is not entitled to exclusivity under
IV. CONCLUSION
For the foregoing reasons, AstraZeneca‘s Motion for Summary Judgment, ECF No. 21, is DENIED, and the FDA‘s Motion for Summary Judgment, ECF No. 26, is GRANTED. An Order consistent with this Memorandum Opinion was issued on June 28, 2012.
Frederick SIMMS, Plaintiff,
v.
DISTRICT OF COLUMBIA, et al., Defendants.
Civil Action No. 12-701 (EGS).
United States District Court, District of Columbia.
July 6, 2012.