U.S. v. Articles of Drug, No. 77-2704

CourtUnited States Courts of Appeals. United States Court of Appeals (5th Circuit)
Writing for the CourtBefore MORGAN, RONEY and GARZA; RONEY
Citation625 F.2d 665
PartiesUNITED STATES of America, Plaintiff-Appellant, v. ARTICLES OF DRUG et al., Defendants-Appellees.
Docket NumberNo. 77-2704
Decision Date12 September 1980

Page 665

625 F.2d 665
UNITED STATES of America, Plaintiff-Appellant,
v.
ARTICLES OF DRUG et al., Defendants-Appellees.
No. 77-2704.
United States Court of Appeals,
Fifth Circuit.
Sept. 12, 1980.

Bruce E. Fein, Edward Lawson, Robert Nicholson, Dept. of Justice, Washington, D. C., for the United States.

Robert G. Pugh, Shreveport La., Alan H. Kaplan, F. Kaid Benfield, Washington, D. C., for Rucker Pharmacal Co.

Page 666

Appeal from the United States District Court for the Western District of Louisiana.

Before MORGAN, RONEY and GARZA, Circuit Judges.

Page 667

RONEY, Circuit Judge:

In this misbranding case under the Food, Drug, and Cosmetic Act, 1 the Government sought to seize large quantities of drugs on the ground they complied with neither a statute requiring a drug's labeling to contain "adequate directions for use," nor an agency-created exemption from that requirement. The district court held that, because these were prescription drugs, the adequate directions for use requirement was satisfied by the inclusion of (1) a cautionary legend on the drugs' labels stating federal law prohibits dispensing without prescription, and (2) sufficient directions to a physician, so the drugs could be prescribed safely and for their intended purposes. On appeal the Government argues the statute requires directions adequate for self-administration by a layman, so that prescription drugs, which by definition can be dispensed safely only under supervision of a physician, must always meet one of the exemptions established by the Food and Drug Administration. Agreeing with the Government's interpretation of the statute, we reverse the district court's award of summary judgment for the drug manufacturer, and remand the case for consideration of the issue whether the drugs here met the exemption standards.

Definitions

Prior to a recitation of the facts, it may be helpful to set forth a number of definitions contained in the statutes and the regulations. Once some definitional common ground has been established, it will be easier to discuss the intricate questions presented by this case, since the language employed by the Act encompasses technical terms of art which do not have their ordinary meaning.

The definition of a "misbranded drug" is found in 21 U.S.C.A. § 352, which sets forth a number of requirements as to a drug's labeling, the violation of any of which will cause the drug to be deemed "misbranded." Of particular relevance here is the requirement found in 21 U.S.C.A. § 352(f) 2 that a drug whose labeling 3 does not include "adequate directions for use" or does not meet a regulatory exemption 4 will be deemed

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"MISBRANDED." THE REGULATIONS DEFINE "adequate directioNs for use" as directions which could be understood for a layman to use a drug safely and for its intended purposes. 5 Section 331(a) makes it unlawful to introduce a misbranded drug into interstate

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commerce and section 334(a)(1) 6 permits the seizure and condemnation of a misbranded drug which either has been introduced into interstate commerce or is held for sale after it or its component parts have been shipped in interstate commerce.

The second term is a "prescription drug," defined in 21 U.S.C.A. § 353(b). 7 A prescription

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drug by its nature is not safe for use except under the supervision of a licensed practitioner. The same section prohibits dispensing such drugs without a prescription. A prescription drug may be deemed misbranded if it is dispensed without a prescription or if at any time prior to being dispensed it does not bear the statement "Caution: Federal law prohibits dispensing without prescription." 8 Prior to being dispensed a prescription drug must meet the misbranding requirements of section 352, including section 352(f). After a prescription drug has been lawfully prescribed, it is exempt from most of the requirements of section 352 but must meet the labeling requirements of section 353(b)(2).

A "new drug" is one which is not generally recognized among qualified scientific experts as safe and effective for the uses described in its labeling. 9 The focus for determination of "new drug" status is primarily on whether the drug is so recognized, not upon the drug's age. It is unlawful to introduce a new drug into interstate commerce without an approved New Drug Application 10 and any drug in violation of section 355 may be seized and condemned under section 334 11 after it has been introduced into interstate commerce.

Facts

In early 1976, the Food and Drug Administration notified Rucker Pharmacal Co. that three prescription drugs used for the treatment or prevention of pain and various types of infections in humans SUL-V, AZO-MED and RU-LOR-N had been determined to be new drugs for which no New Drug Application (NDA) had been approved. Rucker refused to cease marketing the drugs, which it had been marketing for several years, disagreeing with FDA's assessment that the three were new drugs.

On September 20, 1976, the Government instituted the present seizure and condemnation action under section 334(a) against the drugs, alleging the drugs were misbranded because the labeling did not meet the adequate directions for use requirement

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in section 352(f), and did not meet any of the regulatory exemptions. The Government's counsel explained at oral argument that FDA sought to seize the drugs as misbranded rather than as new drugs because, while the drugs' components had been shipped in interstate commerce and the drugs were held by Rucker for sale, a sufficient prerequisite for a misbranding seizure, the finished articles of drug had not yet been introduced into interstate commerce, arguably a prerequisite to a new drug seizure. 12 We do not decide whether the Government could have seized the drugs as new drugs at that time, because that is not an issue on appeal.

After the drugs were seized, Rucker filed a claim for the drugs and an answer to the Government's complaint. In its answer, Rucker claimed the drugs bore adequate directions for use and claimed that, in any event, the drugs' labeling met the requirements of one regulatory exemption from the adequate directions for use requirement. 13

The parties filed cross-motions for summary judgment. The Government argued, consistent with its regulations, that the phrase "adequate directions for use" means directions adequate to enable a layman to use a drug safely and effectively for its labeled uses. 14 Since by definition prescription drugs can only be used safely upon the advice of a physician, it is impossible for a prescription drug's labeling to contain adequate directions for use, 15 according to FDA. Therefore, all prescription drugs which do not meet one of the regulatory exemptions are necessarily misbranded. The applicable exemptions, continues the Government's argument, require that any drug subject to a new drug application must bear the labeling submitted for an NDA. 16 Since these were deemed to be new drugs for which an NDA is required, and since there was no approved NDA, the drugs did not meet any regulatory exemption and were thus due to be condemned.

Rucker disputed the Government's interpretation of the statute as requiring adequate directions for a layman, and contended the drugs did meet the statutory requirements because, first, they bore the required warning that under federal law they cannot be dispensed without prescription 17 and second, the labeling contained adequate directions for a physician to prescribe the drugs safely. Rucker contended that is all the statute requires and therefore it was unnecessary to meet one of the regulatory exemptions. In any event, Rucker contended the three met the requirements of the exemptions found in 21 C.F.R. § 201.100 (1980), which applies to prescription drugs, and specifically contended the drugs were not subject to a new drug application.

The district court granted Rucker's motion for summary judgment on the ground that the cautionary notice, plus adequate directions to enable a physician to prescribe the drugs properly, were all the statute requires. The court determined that the agency regulation which defines adequate directions for use as directions sufficient for self-medication by a layman was, when applied to prescription drugs, unreasonable and inconsistent with the statute. The Government's action was dismissed.

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The Regulations

The principal question on appeal is whether the district court was correct in rejecting the agency's interpretation of this statute. The test is whether the agency's interpretation is unreasonable or inconsistent with the statutory purpose, for if it is not, the district court was not free to substitute its judgment for that of the administrative agency. 18 Long-standing administrative interpretations of the statute under which the agency operates come into court cloaked with a presumption of correctness which may be thrown aside only when the agency has exceeded the authority granted in the statute. 19 This is especially true in the case of remedial legislation like the Food, Drug, and Cosmetic Act. 20

All agree that the pivotal issue is whether the drugs bore "adequate directions for use." See 21 U.S.C.A. § 352(f)(1). The term adequate directions for use is not defined further in the statute. Does it mean only adequate directions for lay use or does it include adequate directions for a physician's use? The agency has apparently interpreted the statute to mean only adequate directions for lay use. In 1952 FDA promulgated regulations defining the phrase as follows:

"Adequate directions for use" means directions under which the layman can use a drug safely and for the purposes for which it is intended.

21 C.F.R. § 201.5 (1980). The Government states that not only has this been its interpretation for the twenty-eight years since the regulation was published, but that the regulation merely codified agency practice since...

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  • United States v. Regenerative Scis., LLC, No. 12–5254.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • February 4, 2014
    ...misbranded.” United States v. An Article of Device, 731 F.2d 1253, 1261 (7th Cir.1984); see United States v. Articles of Drug, 625 F.2d 665, 673 (5th Cir.1980) (holding that § 352(f)(1) requires a drug's labeling to “contain adequate directions for a consumer to engage in self-medication” a......
  • United States v. Regenerative Sciences, LLC, Civil Action No. 10–1327 (RMC).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • July 23, 2012
    ...drug must qualify for an exemption to avoid violating the FFDCA's misbranding provision. See United States v. Articles of Drug, 625 F.2d 665, 673 (5th Cir.1980) (“Since a prescription drug by definition can be used only under a physician's supervision, and is unsuitable for self-medication,......
  • Fort Worth & Denver Ry. Co. v. Goldschmidt, Civ. A. No. CA 4-80-258-E.
    • United States
    • United States District Courts. 5th Circuit. United States District Courts. 5th Circuit. Northern District of Texas
    • June 23, 1981
    ...would be more beneficial in promoting railway safety than "knew or should have known" regulations. See United States v. Articles of Drug, 625 F.2d 665, 672 (5th Cir. Therefore, in adopting regulations which impose a strict liability standard, the FRA interpreted the FRSA as authorizing such......
  • United States v. Hakim, 18 Civ. 5726 (ER)
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • May 26, 2020
    ...qualify for either a regulatory or the statutory exemption, none of which apply here. See United States v. Articles of Drug ... Rucker , 625 F.2d 665, 675 (5th Cir. 1980) ; see also United States v. Premo Pharm. Labs., Inc. , 511 F. Supp. 958, 977 n.23 (D.N.J. 1981) ("A drug is misbranded i......
  • Request a trial to view additional results
14 cases
  • United States v. Regenerative Scis., LLC, No. 12–5254.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • February 4, 2014
    ...misbranded.” United States v. An Article of Device, 731 F.2d 1253, 1261 (7th Cir.1984); see United States v. Articles of Drug, 625 F.2d 665, 673 (5th Cir.1980) (holding that § 352(f)(1) requires a drug's labeling to “contain adequate directions for a consumer to engage in self-medication” a......
  • United States v. Regenerative Sciences, LLC, Civil Action No. 10–1327 (RMC).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • July 23, 2012
    ...drug must qualify for an exemption to avoid violating the FFDCA's misbranding provision. See United States v. Articles of Drug, 625 F.2d 665, 673 (5th Cir.1980) (“Since a prescription drug by definition can be used only under a physician's supervision, and is unsuitable for self-medication,......
  • Fort Worth & Denver Ry. Co. v. Goldschmidt, Civ. A. No. CA 4-80-258-E.
    • United States
    • United States District Courts. 5th Circuit. United States District Courts. 5th Circuit. Northern District of Texas
    • June 23, 1981
    ...would be more beneficial in promoting railway safety than "knew or should have known" regulations. See United States v. Articles of Drug, 625 F.2d 665, 672 (5th Cir. Therefore, in adopting regulations which impose a strict liability standard, the FRA interpreted the FRSA as authorizing such......
  • United States v. Hakim, 18 Civ. 5726 (ER)
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • May 26, 2020
    ...qualify for either a regulatory or the statutory exemption, none of which apply here. See United States v. Articles of Drug ... Rucker , 625 F.2d 665, 675 (5th Cir. 1980) ; see also United States v. Premo Pharm. Labs., Inc. , 511 F. Supp. 958, 977 n.23 (D.N.J. 1981) ("A drug is misbranded i......
  • Request a trial to view additional results

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