Schering Corp. v. Food & Drug Administration (51 F.3d 390, 1995)

OPINION OF THE COURT

MANSMANN, Circuit Judge.

The issue before us, brought in the context of a pioneer drug manufacturer’s challenge to the propriety of FDA approval of non-systemically effective generic drugs pursuant to an abbreviated approval process, is one of first impression in the courts of appeals. We must determine whether the bioequivalence requirements, set forth in section 355(j)(7)(B) of Title I of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Act”), Pub.L. No. 98-417, 98 Stat. 1585 (1984), otherwise known as the “Hatch-Wax-man Amendments” to the Food, Drug and Cosmetic Act (the “FDCA”), are the exclusive means for determining the bioequiva-lenee of generic drugs approved pursuant to the abbreviated new drug application procedure (“abbreviated application” or “ANDA”) embodied in that Act. 21 U.S.C.A. § 355(j) (West Supp.1994). A bioequivalent generic drug is one that the FDA has determined to be as safe and effective as the pioneer drug it copies.

We decide this issue in the context of a challenge by Schering Corporation, a research-based manufacturer and distributor of pharmaceutical products, to the Food and Drug Administration’s final regulation implementing the ANDA provisions of the Act. The FDA regulation at issue, codified at 21 C.F.R. § 320.1(e) (1994), was promulgated in 1992 to implement the bioequivalence requirements for generic drugs approved under the abbreviated application procedure. Schering charges that the FDA impermissi-bly broadened the exclusive statutory definition of bioequivalent by substituting the statutorily prescribed measurement of drug “absorption” with a measurement which calculates when the drug becomes “available at the site of drug action.” See 21 U.S.C.A. § 355(j)(7)(B) (West Supp.1994); 21 C.F.R. § 320.1(e) (1994).

The district court entered summary judgment in favor of the FDA, holding that section 355(j)(7)(B) is not the exclusive means for determining the bioequivalence of a generic drug to its pioneer drug counterpart. On Schering’s appeal, we find the language of 21 U.S.C.A. § 355(j)(7)(B) (West Supp. 1994) ambiguous and consistent with Chevron U.S.A Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), we hold that the FDA regulation at 21 C.F.R. § 320.1(e) (1994) is a permissible construction of that statute. Accordingly, we will affirm the judgment of the district court.

I.

To receive approval under an abbreviated new drug application, a generic drug manufacturer must establish that its drug is the bioequivalent of a pioneer drug. 21 U.S.C.A. § 355(j)(2)(A)(iv) (West Supp.1994). The Act provides:

A drug shall be considered to be bioequiva-lent to a listed drug if—

(i) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same ... dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses; or

(ii) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the listed drug when administered at the same ... dose of the therapeutic ingredient under similar experimental conditions ... and the difference from the listed drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use and is considered medically insignificant for the drug.

21 U.S.C.A. § 356