Carter-Wallace, Inc. v. John W. Gardner, Secretary of Health, Education, and Welfare, and James L. Goddard, Commissioner of Food and Drugs

417 F.2d 1086, 1969 U.S. App. LEXIS 10181
CourtCourt of Appeals for the Fourth Circuit
DecidedNovember 4, 1969
Docket12200_1
StatusPublished
Cited by13 cases

This text of 417 F.2d 1086 (Carter-Wallace, Inc. v. John W. Gardner, Secretary of Health, Education, and Welfare, and James L. Goddard, Commissioner of Food and Drugs) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Carter-Wallace, Inc. v. John W. Gardner, Secretary of Health, Education, and Welfare, and James L. Goddard, Commissioner of Food and Drugs, 417 F.2d 1086, 1969 U.S. App. LEXIS 10181 (4th Cir. 1969).

Opinion

BUTZNER, Circuit Judge:

The Commissioner of Food and Drugs subjected meprobamate and compounds containing meprobamate in combination with other drugs to special controls under the Federal Food, Drug & Cosmetic Act. 1 Carter-Wallace, Inc., a manufacturer and distributor of the drug, petitioned for review under the statutory proceedings authorized by the Act and the general provisions of the Administrative Procedure Act. 2 We affirm the Commissioner’s order because we believe that his decision is supported by substantial evidence and that it is warranted by law.

*1089 I.

In 1965, Congress amended the Federal Food, Drug & Cosmetic Act to provide control over barbiturates, amphetamines, and other drugs having a similar effect on the central nervous system. 3 These drugs were classified as “depressant or stimulant drugs.” Control over them is accomplished through increased record keeping and inspection requirements, regulation of intrastate traffic, and by making possession of the drugs, other than by the user, illegal outside of the legitimate channels of commerce. A prescription for a depressant or stimulant drug may not be filled more than six months after the date on which it was issued and it may not be refilled more than five times unless renewed by the prescribing physician. 4

The genesis of these proceedings is § 201 (v) of the amendments [21 U.S.C. § 321 (v)], which provides in part:

“The term ‘depressant or stimulant drug’ means—

“(1) any drug which contains any quantity of (A) barbituric acid * *;

“(2) any drug which contains any quantity of (A) amphetamine * *;

“(3) any drug which contains any quantity of a substance which the Secretary, after investigation, has found to have, and by regulation designates as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system * * * *»

The legislative history of this section clearly reflects the concern with which Congress viewed meprobamate. The House Committee’ Report states: 5

“The committee considered the advisability of specifically designating meprobamate [and five other drugs] as ‘depressant or stimulant drugs.’ It was decided that this should not be done because the Secretary of Health, Education, and Welfare will, under the provisions of proposed section 201 (v) (3) of the Federal Food, Drug, and Cosmetic Act, consider designating these drugs as ‘depressant or stimulant drugs’ and that it would be inadvisable to single out these drugs while leaving out others having substantially similar abuse potentials. The committee expects the Secretary to take early action with respect to the consideration of the listing of these six drugs.”

Against this background, the Food and Drug Administration conducted extensive hearings that culminated in subjecting meprobamate to control as a depressant drug. In canvassing the record upon review, we are required to give conclusive effect to the Commissioner’s findings of fact that are supported by substantial evidence. 21 U.S.C. § 371 (f)- 6

Meprobamate is one of a group of drugs known as minor tranquilizers which are used for the symptomatic relief of anxiety and tension associated with psychoneurotic disorders. It was first used in clinical trials in 1952, and it has been widely distributed commercially since 1955 in tablets or capsules of 200 and 400 milligram doses. Carter-Wallace has produced enough of the drug to make approximately 14 billion tablets. It may be dispensed only by prescription, and an estimated 500 million prescriptions have been written. The maximum recommended adult dosage is 2,400 milligrams daily. Meprobamate is a safe, effective drug when it is taken in accordance with the manufacturer’s recommendation under a physician’s direction.

*1090 In order to subject meprobamate to the Act’s special controls the Commissioner must find, first, that it has a depressant effect on the central nervous system; second, that it has a potential for abuse; and, third, that this potential results from its depressant effect on the central nervous system.

There can be no doubt about the sufficiency of the proof of the first element. The regulations [21 C.F.R. § 166.2] provide that a drug has a depressant effect on the central nervous system if there is substantial evidence that the drug may produce (a) a calming effect or relief of emotional tension or anxiety; or (b) drowsiness, sedation, sleep, stupor, coma, or general anesthesia; or (e) mood depression or apathy. Nearly all of the medical witnesses testified that the major therapeutic effects of meprobamate are to calm the 'patient and to give relief from emotional tension or anxiety. A number of witnesses established that large dosages of meprobamate cause stupor and induce apathy. The precise way in which meprobamate achieves these effects is not known with certainty, but the undisputed evidence establishes that it acts upon the central nervous system.

In selecting “potential for abuse” as one of the criteria for subjecting a drug to special control, the House Committee did not intend this to be determined on the basis of the drug’s having only a potential for isolated or occasional non-therapeutic purposes. Instead, the eom-mittee recommended that a drug’s potential for abuse should be determined “on the basis of its having been demonstrated to have such depressant or stimulant effect on the central nervous system as to make it reasonable to assume that there is a substantial potential for the occurrence of significant diversions from legitimate drug channels, significant use by individuals contrary, to professional advice, or substantial capability of creating hazards to the health of the user or the safety of the community.” 7

The evidence on this issue is in sharp conflict. It ranges from testimony of Carter-Wallace’s experts that the potential for abuse of candy or aspirin is greater than for meprobamate to testimony from a government witness that he became so uneasy about alcoholics’ affinity for the drug he stopped prescribing it for them. A number of well-qualified medical witnesses called by Carter-Wal-Iace testified that while treating patients with meprobamate over a period of years they had observed no evidence of the drug’s abuse, or at the most they had seen only isolated or occasional cases.

Doctors testifying for the government presented a different picture. They told of patients who used meprobamate to the extent that they became intoxicated —with staggering gait, slurred speech, and impaired coordination.

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417 F.2d 1086, 1969 U.S. App. LEXIS 10181, Counsel Stack Legal Research, https://law.counselstack.com/opinion/carter-wallace-inc-v-john-w-gardner-secretary-of-health-education-ca4-1969.