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PFIZER INC. v. SHALALA

April 16, 1998

PFIZER INC, Plaintiff,
v.
DONNA SHALALA, Secretary, United States Department of Health and Human Services, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, MICHAEL FRIEDMAN, M.D., Acting Commissioner, Food and Drug Administration, and UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendants, and MYLAN PHARMACEUTICALS, INC., and PENWEST PHARMACEUTICAL GROUP, Defendant-Intervenors.



The opinion of the court was delivered by: FRIEDMAN

OPINION

 This matter initially came before the Court on plaintiff's motion for preliminary injunction. After oral argument on August 1, 1997, the parties agreed to convert the motion for preliminary injunction into a motion for summary judgment. The federal defendants, Donna Shalala, the United States Department of Health and Human Services, Michael Friedman and the United States Food and Drug Administration, and defendant-intervenors, Mylan Pharmaceuticals, Inc. and Penwest Pharmaceutical Group, filed oppositions to plaintiff's motion for summary judgment. The federal defendants also filed a motion to dismiss, and the defendant-intervenors filed cross motions for summary judgment. Amicus briefs in support of the defendants were filed by the National Pharmaceutical Alliance and the National Association of Pharmaceutical Manufacturers.

 Upon consideration of all the papers filed by the parties and the arguments presented, the Court denies plaintiff's motion for summary judgment and enters judgment for defendants. An Order and Judgment was entered for defendants on March 31, 1998. The reasons for that decision are set forth herein.

 I. BACKGROUND

 Plaintiff Pfizer, Inc. brings this action in hopes that this Court will order the FDA to reject the abbreviated new drug application ("ANDA") that Mylan Pharmaceuticals, Inc. has filed in support of a generic version of a sustained-release nifedipine tablet. Pfizer is the company that first developed the non-generic or pioneer version of this drug.

 Pfizer maintains that the FDA received Mylan's ANDA in derogation of the prerequisites imposed by statute and by FDA's own regulations regarding the receipt of ANDAs for generic drugs. It argues that it is not permissible under the Federal Food, Drug and Cosmetic Act for the FDA to permit two drugs that deliver their active ingredients by different means to be considered the "same" dosage form. Pfizer therefore asks the Court to order the FDA to overhaul its system of classifying the dosage forms of drugs.

 Pfizer's pioneer drug, Procardia XL, is a controlled release drug in which the full dose of the active ingredient in the drug, nifedipine, is released slowly, over time. Nifedipine is a drug used in the management of angina and hypertension. Complaint P 22. There are several mechanisms used in controlled release oral drugs in order to regulate the release of a drug's active ingredients. Procardia XL uses a patented oral osmotic pump release mechanism to release the nifedipine it contains. Osmotic release systems function by slowly releasing the drug's active ingredients from a shell; a pump or push component inside the shell swells when gastrointestinal fluid enters the shell to expel the active ingredient. Procardia XL's osmotic pump device is covered by four patents, and the size of the nifedipine crystals used in the drug is also patented. *fn1"

 A. The Statutory and Regulatory Regime

 Pursuant to the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., manufacturers like Pfizer who are seeking to market a new drug generally must submit to the FDA a full new drug application ("NDA"), which requires substantial clinical studies demonstrating the drug's safety and efficacy in patients suffering from the condition for which the drug is intended. See 21 U.S.C. § 355(b)(1)(A); 21 C.F.R. § 314.50. If the new drug is found to be safe and effective after extensive, detailed review by the FDA, approval is given to market the drug for the specific condition in a specified dosage form at a specified strength by a specified route of administration. See 21 C.F.R. § 314.50(a). The FDA approved Pfizer's NDA for Procardia XL on September 6, 1989.

 Congress also has passed legislation that provides an alternative, "abbreviated" application procedure for certain generic imitations of NDA-approved drugs, or pioneer drugs. 21 U.S.C. § 355(j). These statutory provisions were added to the Federal Food, Drug and Cosmetic Act through the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984), generally known as the "Hatch-Waxman Amendments." Pursuant to these amendments,

 
a producer of generic drugs may file applications that rely heavily on approved applications for "listed" (generally name-brand) drugs. . . . This expedited process permits generic drug applications to piggy-back on clinical findings that FDA has already embraced. Accordingly, the application must demonstrate, among other things, that the generic drug is the "bioequivalent" of the listed drug and that it is properly manufactured and labeled.

 In re Barr Laboratories, 289 U.S. App. D.C. 187, 930 F.2d 72, 73 (D.C. Cir.), cert. denied, 502 U.S. 906, 116 L. Ed. 2d 241, 112 S. Ct. 297, 112 S. Ct. 298 (1991). This piggy-backing process spares applicants attempting to market generic versions of FDA-approved pioneer drugs the need to repeat the time-consuming and costly investigations that were necessary to establish the safety and efficacy of the pioneer drug. Instead, generic applicants may submit an abbreviated new drug application ("ANDA") containing, among other things, "information to show that the . . . dosage form . . . [is] the same as" the pioneer drug and "information to show the [generic] drug is bioequivalent" to the pioneer drug. 21 U.S.C. § 355(j)(2)(A)(iii) and (iv). The pioneer drug previously approved by the agency is referred to as the "listed drug" or "reference listed drug." 21 U.S.C. § 355 (j)(2)(A)(i).

 Under the FDCA and FDA regulations, the ANDA procedure is only available after the FDA makes a "threshold determination that the ANDA is sufficiently complete to permit a substantive review." 21 C.F.R. § 314.101(b)(1). An ANDA must contain, inter alia, information to show that (1) the active ingredient(s), (2) the route of administration, (3) the dosage form, and (4) the strength of the proposed generic drug are the "same as" those of the pioneer drug. 21 U.S.C. § 355(j)(2)(A)(ii) and (iii); 21 C.F.R. § 314.94(a)(5) and (6). *fn2" If the FDA finds that the ANDA "on its face" contains this required information, then the FDA proceeds to the more in depth substantive review phase of the ANDA process to determine whether to approve the proposed generic drug for marketing and use. If, on the other hand, the FDA determines that an ANDA does not "on its face" contain certain required information, the FDA may refuse to receive it, and the review process stops there. 21 C.F.R. § 314.101(d)(3).

 An applicant seeking approval of a drug that is similar but not identical to the pioneer drug with respect to its active ingredients, route of administration, dosage form or strength must first seek permission from the FDA to use the ANDA procedure. The applicant must file and the FDA must approve a "suitability petition" before it is allowed to file an ANDA. 21 U.S.C. § 355(j)(2)(C); 21 C.F.R. § 314.93. The suitability petition permits the FDA to assess the differences between a generic imitation and the reference listed drug and to determine whether other tests or independent clinical trials are necessary to demonstrate the product's safety and efficacy and whether labeling varying from the labeling of the reference listed drug is appropriate. 21 U.S.C. § 355(j)(2)(C)(i); 21 C.F.R. § 314.93. Only after the approval of a suitability petition may an ANDA be filed for a generic drug that has only similar -- but not the same -- active ingredients, route of administration, dosage form or strength. 21 U.S.C. 355(j)(2)(C).

 If the FDA accepts an ANDA as being properly filed, either because it is sufficiently complete on its face or because a suitability petition has been approved, the FDA then proceeds to the substantive review stage. During the substantive review stage, the FDA goes beyond its preliminary threshold determination and this time thoroughly reviews the sufficiency of the ANDA's information. The applicant must show, inter alia, that the generic product (1) has the same active ingredients, route of administration, dosage form and strength as the pioneer drug, (2) is bioequivalent to the pioneer drug, and (3) is safe under the conditions prescribed, or, in the case of an ANDA that has been filed subsequent to the approval of a suitability petition, the ANDA must contain sufficient information about the particular aspect of the drug that is different from the pioneer drug. 21 U.S.C. § 355 (j)(3). If, after substantive review, the FDA determines that the information contained in the ANDA is in fact insufficient regarding any one of these criteria, the FDA will refuse to approve the ANDA. Id.

 If the FDA finds that the information in the ANDA is sufficient under the FDCA and FDA regulations, it will approve the ANDA and issue a notice that the generic imitation is therapeutically equivalent to the reference listed drug. This notice typically permits the imitation to be sold by pharmacists to patients as a substitute for the (usually more expensive) reference listed drug and to be included on state and insurance company lists as a therapeutically ...


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