Astrazeneca Pharms. LP v. Food & Drug Admin.

• Citation: 850 F.Supp.2d 230
• Decision Date: 23 March 2012
• Docket Number: Civil Action No. 12–00388(CKK).
• Parties: ASTRAZENECA PHARMACEUTICALS LP, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services, Defendants.
• Court: U.S. District Court — District of Columbia

850 F.Supp.2d 230

ASTRAZENECA PHARMACEUTICALS LP, Plaintiff,

v.FOOD AND DRUG ADMINISTRATION, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services, Defendants.

Civil Action No. 12–00388(CKK).

United States District Court,

District of Columbia.

March 23, 2012.

Timothy C. Hester, Covington & Burling LLP, Benjamin C. Block, U.S. Commodity Futures Trading Commission, Washington, DC, for Plaintiff.

Gerald Cooper Kell, U.S. Department of Justice, Civil Division, Office of Consumer Litigation, Washington, DC, for Defendants.

MEMORANDUM OPINION

COLLEEN KOLLAR–KOTELLY, District Judge.

Plaintiff AstraZeneca Pharmaceuticals LP (“AstraZeneca”) holds new drug applications for SEROQUEL® (“Seroquel”) and SEROQUEL XR® (“Seroquel XR”), antipsychotic drugs used to treat serious psychological disorders such as schizophrenia. Since AstraZeneca first obtained approval to market these drugs in the United States from the Food and Drug Administration (the “FDA”), it has been free to market them without “generic” competition. Next week, on Monday, March 26, 2012, one of AstraZeneca's exclusivity rights, a so-called “pediatric exclusivity” period, will expire, leading AstraZeneca to become concerned that the FDA will then give final approval to one or more abbreviated new drug applications that would allow generic competitors to enter the market.

For its part, AstraZeneca maintains that it is entitled to an additional exclusivity right, a so-called “new patient population” exclusivity period, which, in AstraZeneca's view, would effectively extend its monopoly on the market through December 2, 2012. On this basis, AstraZeneca filed two “citizen petitions” with the FDA in September 2011, essentially asking the agency to represent in advance of the March 26, 2012 expiration of AstraZeneca's pediatric exclusivity period that it does not intend to give final approval to any generic competitors until after December 2, 2012. On March 7, 2012, the FDA denied both of AstraZeneca's citizen petitions, taking the position that it has not yet made a final determination to approve or disapprove any applications by potential generic competitors. On March 12, 2012, AstraZeneca responded by bringing this action against the FDA,¹ claiming that the agency has run afoul of the Administrative Procedure Act by denying AstraZeneca's citizen petitions.

Currently before the Court is AstraZeneca's [3] Application for Preliminary Injunction,² through which AstraZeneca seeks an order enjoining the FDA from giving final approval to a generic version of Seroquel or Seroquel XR before this action is resolved on the merits. Because AstraZeneca's pediatric exclusivity period will end on March 26, 2012, AstraZeneca's application has been briefed on an expedited basis. Upon careful consideration of the parties' submissions, the administrative record,³ the relevant authorities, and the record as a whole, the Court finds that AstraZeneca has failed to make a clear showing that it is entitled to the extraordinary remedy of a preliminary injunction. Accordingly, AstraZeneca's Application for Preliminary Injunction shall be DENIED. Furthermore, because the Court concludes that AstraZeneca's only claim is not yet ripe for judicial review, this action shall be DISMISSED WITHOUT PREJUDICE.

I. BACKGROUND

A. Statutory and Regulatory Background

1. New Drug Applications and Abbreviated New Drug Applications

In the United States, new drugs, including “generic” versions of previously approved “pioneer” or “innovator” drugs, may not be marketed without the FDA's prior approval. See21 U.S.C. § 355(a). The approval process is governed by the Federal Food, Drug, and Cosmetic Act, as amended by, among other enactments, the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98–417, 98 Stat. 1585, commonly referred to as the “Hatch–Waxman Amendments.” For pioneer drugs, a company files what is known as a new drug application (“NDA”) supported by extensive scientific data showing that the drug is both safe and effective. See21 U.S.C. § 355(b)(1). Often,this process requires pioneer drug applicants to conduct costly and time-consuming clinical studies and to submit full reports to the FDA. See id.

Through the Hatch–Waxman Amendments, Congress sought to encourage the development of generic versions of pioneer drugs. Most notably, once the FDA approves a pioneer drug, a competitor seeking to market a generic version may file what is known as an abbreviated new drug application (“ANDA”). See id. § 355(j). Unlike a pioneer drug applicant, a generic drug applicant generally need not submit extensive scientific data and clinical studies showing that the drug is safe and effective, but rather may rely on the data and studies that supported the approval of the pioneer drug. See id. In this way, the Hatch–Waxman Amendments reduced the barriers to market entry facing potential generic competitors.

2. The “Sameness” Requirement

Generally speaking, the presumption is that the labeling for any generic drug will mirror the labeling for the pioneer drug. By statute, a generic applicant must submit proposed labeling with its application for approval, which must be “the same as” the labeling approved for the pioneer drug unless changes are required (1) because the generic drug has a different active ingredient or has a different route of administration, dosage form, or strength or (2) because the pioneer drug and the generic drug are produced or distributed by different manufacturers. 21 U.S.C. § 355(j)(2)(A)(v). “[S]uch differences between the applicant's proposed labeling and labeling approved for the reference listed drug may include differences in expiration date, bioavailability, or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines or other guidance, or omission of an indication or other aspect of labeling protected by patent or accorded exclusivity.” 21 C.F.R. § 314.94(a)(8)(iv).

3. The Three–Year “New Patient Population” Exclusivity

Through the Hatch–Waxman Amendments, even while creating new incentives for the development of generic drugs, Congress sought to encourage innovation. To this end, pioneer drug companies are entitled to certain periods of marketing exclusivity during which they are protected from generic competition. Broadly speaking, these exclusivity periods work in practice either by placing a moratorium on the submission of ANDAs by potential generic competitors or by delaying the effective date that the FDA can give final approval to an ANDA.

Included among these various exclusivity periods is what is sometimes referred to as a “new patient population” or “new indication” exclusivity because it frequently arises when a pioneer drug company conducts post-approval clinical studies, submits a supplemental application to the FDA, and secures the FDA's approval to market an approved drug to a new population or for a new indication.⁴ A pioneer drug company is entitled to a three-year new patient population exclusivity period under the following circumstances:

If a supplement to [an NDA] ... is approved ... and the supplement contains reports of new clinical investigations ⁵ (other than bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the [FDA] may not make the approval of an [ANDA] submitted ... for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement....

21 U.S.C. § 355(j)(5)(F)(iv). “[A]n applicant is not entitled to 3–year exclusivity merely because it supplements an approved application based in part on a clinical investigation.” Abbreviated New Drug Application Regulations, 59 Fed.Reg. 50,338, 50,357 (Oct. 3, 1994). Rather, as the statute makes clear, the clinical investigation must be “essential” to approval. 21 U.S.C. § 355(j)(5)(F)(iv). If a pioneer drug company is entitled to a new patient population exclusivity, then, for a three-year period, the FDA is precluded from giving final approval to an ANDA “submitted ... for a change approved in the supplement.” 21 U.S.C. § 355(j)(5)(F)(iv). The FDA has interpreted this language as establishing a relationship between the information obtained from the clinical investigation, the change approved through the pioneer drug company's supplemental application, and the scope of the information relied upon by a generic competitor in a specific ANDA. In short, the FDA will not give final approval to an ANDA that “relies on the information supporting a change approved in the supplemental [NDA].” 21 C.F.R. § 314.108(b)(5)(h).

4. Tentative and Final Approval of ANDAs

When the FDA first receives an ANDA from a potential generic competitor, it makes the threshold determination of whether the application should even be accepted for processing, which simply requires that the application be “sufficiently complete to permit a substantive review.” 21 C.F.R. § 314.101(b)(1). Thereafter, if the FDA finds that the generic drug satisfies the requirements for approval at the time of review, but final approval is blocked by a stay, a marketing exclusivity period, or some other barrier, the FDA will give the drug “tentative approval.” 21 U.S.C. § 355(j)(5)(B)(iv)(II)(dd)(AA). By statute, “[a] drug that is granted tentative approval ... is not an approved drug and shall not have an effective approval until the [FDA] issues an approval after any necessary additional review of the application.” Id. § 355(j)(5)(B)(iv)(II)(dd)(BB). “In order for an approval to be made effective ... the applicant must receive an approval letter from the agency indicating that the application has received final approval.” 21 C.F.R. § 314.107(b)(3)(v). Ultimately, if the FDA finds the generic drug satisfies the requirements for approval, it must approve the application. See21 U.S.C....