U.S. v. 50 Boxes More or Less, 89-2166

• Court: United States Courts of Appeals. United States Court of Appeals (1st Circuit)
• Writing for the Court: Before BREYER, Chief Judge, BOWNES, Senior Circuit Judge, and TORRUELLA; BREYER
• Citation: 909 F.2d 24
• Parties: UNITED STATES of America, Plaintiff, Appellee, v. 50 BOXES MORE OR LESS etc., et al., Defendants, Appellees, Appeal of SANDOZ PHARMACEUTICALS CORPORATION, Claimant. . Heard
• Docket Number: No. 89-2166,89-2166
• Decision Date: 09 May 1990

Page 24

909 F.2d 24 UNITED STATES of America, Plaintiff, Appellee,
v.
50 BOXES MORE OR LESS etc., et al., Defendants, Appellees,
Appeal of SANDOZ PHARMACEUTICALS CORPORATION, Claimant. No. 89-2166. United States Court of Appeals,
First Circuit. Heard May 9, 1990.
Decided July 19, 1990.

Page 25

Daniel R. Dwyer, with whom Peter O. Safir, Kleinfeld, Kaplan and Becker, Mary Morrissey Sullivan, Sullivan, Sullivan & Pinta, and Anne S. Davidson, Sandoz Pharmaceuticals Corp., were on brief for defendant, appellants.

Mary K. Pendergast, Associate Chief Counsel for Enforcement, Food and Drug Administration, with whom Wayne A. Budd, U.S. Atty., Paul G. Levenson, Asst. U.S. Atty., and Margaret Jane Porter, Chief Counsel, Food and Drug Administration, were on brief for appellee.

Before BREYER, Chief Judge, BOWNES, Senior Circuit Judge, and TORRUELLA, Circuit Judge.

BREYER, Chief Judge.

The government has seized fifty boxes of a prescription drug called Cafergot P-B Suppository, a drug that contains two active ingredients (caffeine, ergotamine) designed to stop vascular headaches such as migraine and two other active ingredients (pentobarbital, bellafoline) designed to stop nauseous side effects resulting from the first two ingredients. The government has a legal right to seize these products if (1) the drug (which we shall call "CPB") is a "new drug" and (2) its manufacturer, Sandoz Pharmaceuticals, has failed to present "substantial evidence" that the drug is "effective." See 21 U.S.C. Secs. 355(a, b), 331(d), 334. CPB is a "new drug" unless it is "g enerally r ecognized, a mong experts ... as § afe and e ffective for use under the conditions prescribed ... in the labeling" (i.e., unless it is what drug regulators call "GRASE"). See 21 U.S.C. Sec. 321(p)(1). The district court, concluding that CPB is a "new drug" (i.e., not GRASE) and that Sandoz has not presented "substantial evidence" of its effectiveness, granted the government's motion for summary judgment. See 721 F.Supp. 1462 (D.Mass.1989). Sandoz appeals.

Were the law to give ordinary English-language meanings to the statutory words quoted in the preceding paragraph, the record created for summary judgment purposes would strongly support Sandoz.

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CPB is not a new drug; Sandoz has sold it successfully for thirty-five years. The anti-headache ingredients in CPB are the same as those in another Sandoz product approved as safe and effective by both the Food and Drug Administration and the National Academy of Sciences, and Sandoz presents evidence that the anti-nausea ingredients in CPB are effective for that purpose. Six experts in the treatment of headache pain prepared affidavits attesting to the general medical consensus, based on published reports and clinical experience, that CPB is safe and effective for the treatment of vascular headache.

The law, however, does not give the quoted words their ordinary English meanings. For example, the term "new drug" means "any drug" that is not GRASE. See 21 U.S.C. Sec. 321(p)(1). The term "substantial evidence" does not mean what it means elsewhere in administrative law, namely, " 'such relevant evidence as a reasonable mind might accept as adequate to support a conclusion,' " see Universal Camera Corp. v. NLRB, 340 U.S. 474, 477, 71 S.Ct. 456, 459, 95 L.Ed. 456 (1951) (quoting Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229, 59 S.Ct. 206, 217, 83 L.Ed. 126 (1938)). It means "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts ...," which "adequate and well-controlled investigations" must satisfy a host of technical scientific requirements, including "a valid comparison with a control" such as an "active treatment trial" that includes "randomization and blinding of patients or investigators" (double-blind studies). See 21 U.S.C. Sec. 355(d); 21 C.F.R. Sec. 314.126(b)(2)(iv) (1989). Finally, and perhaps most surprisingly, the exception for drugs "generally recognized as safe and effective" is not an exception at all. In Weinberger v. Hynson, Westcott & Dunning, the Supreme Court held that, to qualify as GRASE, a drug must meet the same elaborate, technical, scientific testing requirements that it would have to meet to win approval as a "new drug." The Court wrote that

the hurdle of "general recognition" of effectiveness requires at least "substantial evidence" of effectiveness for approval of an NDA [i.e., "new drug" application]. In the absence of any evidence of adequate and well-controlled investigation supporting the efficacy of [a drug], a fortiori, [the drug] ... would be a "new drug" subject to the [new drug] provisions of the Act.

412 U.S. 609 at 629-30, 93 S.Ct. 2469 at 2483, 37...