Carter-Wallace, Inc. v. Gardner

• Decision Date: 04 November 1969
• Docket Number: No. 12200.,12200.
• Citation: 417 F.2d 1086
• Parties: CARTER-WALLACE, INC., Petitioner, v. John W. GARDNER, Secretary of Health, Education, and Welfare, and James L. Goddard, Commissioner of Food and Drugs, Respondents.
• Court: U.S. Court of Appeals — Fourth Circuit

417 F.2d 1086 (1969)

CARTER-WALLACE, INC., Petitioner, v. John W. GARDNER, Secretary of Health, Education, and Welfare, and James L. Goddard, Commissioner of Food and Drugs, Respondents.

No. 12200.

United States Court of Appeals Fourth Circuit.

Argued October 31, 1968.

Decided November 4, 1969.

COPYRIGHT MATERIAL OMITTED

Stephen R. Lang, Alexandria, Va. (William L. Hanaway, Breed, Abbott & Morgan, New York City, Ralph H. Ferrell, Jr., and Hunton, Williams, Gay, Powell & Gibson, Richmond, Va., on brief), for petitioner.

William W. Goodrich, Asst. Gen. Counsel, Dept. of Health, Education, and Welfare (Joanne S. Sisk and Eugene M. Pfeifer, Attys., Dept. of Health, Education, and Welfare, and Fred M. Vinson, Jr., Asst. Atty. Gen., and William E. Ryan, Atty., Dept. of Justice, on brief), for respondents.

Before HAYNSWORTH, Chief Judge, BUTZNER, Circuit Judge, and HUTCHESON, Senior District Judge.^*

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.

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.

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 (c) 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 nontherapeutic purposes. Instead, the committee 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-Wallace 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. Testimony also disclosed that some persons who took excessive doses of meprobamate felt "high" or experienced euphoria. Credible evidence established that continuous use of the drug produces tolerance to its effects. This, in turn, requires more of the drug to achieve the original effect. Excessive use of meprobamate creates physical dependence upon the drug. Its withdrawal from persons who use it to excess may be followed by nausea, insomnia, muscle tremors, and anxiety.

Although complete statistics on the type of drugs used for suicide and attempted suicide by poison are not available, the evidence indicated that meprobamate had been used alone or in conjunction with other drugs in a number of cases. Several drugs are used more frequently than meprobamate for successful suicides. But one qualified researcher observed that meprobamate's use in attempted suicides was surpassed only by barbiturates.

The hearings disclosed significant diversion of meprobamate from legitimate trade. During the 1956-1966 decade, the Food and Drug Administration recorded 1,515 convictions for illegal sales of prescription drugs. Of these, 173 or approximately 11% involved meprobamate. Evidence also exposed how easily the drug can be illegally purchased.

The legislative history reveals that when the phrase "potential for abuse" was adopted, the House Committee rejected the suggestion that special controls should be limited "to those drugs as to which substantial abuse had been shown." The Committee Report emphasizes that the Commissioner should not be required to wait "until a number of lives have been destroyed or substantial problems have already arisen before designating a drug as subject to controls * * *."⁸ Thus, the existence of abuse is relevant to forecast future abuse, but the incidence of present abuse is not the test which the Commissioner must apply. Instead, he has been charged with the responsibility of assaying future or potential abuse. As might be expected, witnesses differed as much in their opinions about the future as they had concerning their observations of the present. However, a number of qualified experts expressed the view that as access to barbiturates was limited by controls, the abuse of meprobamate would increase unless it also was controlled. Barbiturates and meprobamate can suppress or relieve the withdrawal reaction that an excessive user of alcohol suffers when he is abruptly deprived of his intoxicant. Although most drugprone alcoholics seek barbiturates, a significant number take meprobamate. The...