November of last year. You see in this photograph over 100,000 tablets and capsules which were involved in this transaction.

Senator YARBOROUGH. Is this the photograph in which over 100,000 amphetamine tablets were being sold by a North Carolina bootlegger?

Mr. LARRICK. That is exactly right, Senator Yarborough.

Senator YARBOROUGH. I notice you have different colors, red, white, orange, green, and black.

Mr. LARRICK. The drugs are the same, but they just are different colors, just different colors.

Senator YARBOROUGH. Are not the properties relatively the same or are they vastly different in those different colors?

Mr. LARRICK. No; the different color does not make any difference in their characteristics. They are capable of overstimulation and causing various types of harm which I have described. (The photograph referred to above follows:)

This represents the drugs in a single buy made by an undercover agent in North Carolina during November of 1963. Over 100,000 tablets and capsules of amphetamine and barbiturates were involved in this transaction. chase was made from a bootlegger who sold in wholesale-size lots.

The pur

FDA Photo

Senator YARBOROUGH. At what price did the bootlegger sell at wholesale? Do you have the figures?

Mr. LARRICK. It was running at about $30 a thousand.
Senator YARBOROUGH. About $30 a thousand to bootleg it?

Mr. LARRICK. That is right. He could buy them at a dollar a thousand.

Senator YARBOROUGH. And those 100,000 will sell to the retail trade at what price?

Mr. LARRICK. 5 to 10 cents

per tablet.

Senator YARBOROUGH. All right. Go ahead.

Mr. LARRICK. In order to make these seizures under existing law we have had to improvise and take chances on our ability to establish the prior interstate shipment of the drugs.

In an effort to assess the use and potential misuse of these drugs, we conducted a survey of all known manufacturers, brokers, and distributors of basic amphetamine and similar stimulant chemicals and of barbiturates. We wanted to obtain accurate and current information about the amounts produced, the amounts exported and imported, and the identity of all firms engaged in such enterprise.

Unfortunately, our survey of production figures was incomplete because records kept by several basic manufacturers were inadequate and also because two of the Nation's largest pharmaceutical firms declined, as was their right, to provide the information requested. Nevertheless, we did learn that at least enough basic material was produced in 1962 to make over 9 billion doses of barbiturates and amphetamines. Probably half of these end up on the bootleg market. While we have been discussing barbiturates and amphetamines almost exclusively, it is important to point out that this bill is aimed at other types of drugs capable of causing similar or related ill effects and there are a number of such drugs already known to be misused to some extent.

For example, you undoubtedly recall rather extensive publicity some months ago about serious abuses that have developed around some of our larger educational and research institutions from experimentation with drugs which produce hallucinations and other mental aberrations when administered in very minute doses. One of these is a chemical commonly referred to as LSD25 (its chemical name is d-lysergic acid diethylamide tartrate).

In addition to producing the immediate hallucinations and aberrations which the experimenters sought, this drug has been found capable of inducing lasting changes in the mental and emotional stability of some users and there are instances in which college students who took doses of the drug for thrills or for nonscientific experimentation became disturbed to the point that they had to leave college or even enter mental institutions. The drug also produces strong suicidal tendencies in some victims. We have just terminated an action, Mr. Chairman, in the Federal court, against two men who were arrested on April 3, 1963, when they attempted to sell an FDA inspector $15,000 worth of LSD 25 at his home. On other occasions they had offered over $165,000 worth of the drug to FDA undercover inspectors.

Statements made to our investigators before the trial and testimony given during the trial indicated that this drug was manufactured in Israel, shipped to Mexico, smuggled into California, transported to Canada, and returned to California where we were able to apprehend it.

Senator YARBOROUGH. Mr. Commissioner, will you pause for a moment. I see Senator Dodd, the author of this bill, has come into the room, though he modestly remains in the back.

Senator Dodd, would you come around and join us on the bench? You are to be the next witness.

Mr. LARRICK. If he wishes, I would be glad to step aside.

Senator YARBOROUGH. Come around, Senator Dodd, and join us. I know your plane was delayed.

We are glad to have you here. We know you have pushed this legislation so diligently over the years.

Senator DODD. Thank you, Mr. Chairman. I am sorry I was late. Senator YARBOROUGH. Proceed, sir.

Mr. LARRICK. The evidence indicated that while the drug was in Canada, the two defendants had a party attended by several other people at which LSD25 was consumed. One of the persons present was a newspaperman who wished to leave early. The defendants beat him up very severely, carried him back to the house where the party was being given, held him prisoner for approximately 24 hours, and then realizing that he was seriously in need of medical attention, arranged for him to be attended by a physician and transferred to a hospital where he underwent treatment for several days.

The defendants, Bernard Roseman and Bernard Copely, were charged with nine counts of smuggling, misbranding the drug, dispensing a prescription drug without a prescription, and conspiracy. The Honorable George B. Harris, Federal court judge, sentenced Copely and Roseman to 5 years each on two smuggling charges, and 1 year each on seven charges of violation of the Federal Food, Drug, and Cosmetic Act. In sentencing the defendants, Judge Harris, a distinguished and eminent jurist, said:

I think there is a very grave responsibility upon the part of the Food and Drug authorities to make appropriate recommendations to such congressional committees as may be involved with respect to appropriate legislation in connection with this type of drug as in connection with kindred types of drugs.1

We are pleased to bring his views as well as ours to your attention today.

President Kennedy, in his consumers' protective message of March 15, 1962, recommended legislation which would establish an enforcible system of preventing the illicit distribution of habit-forming barbiturates and amphetamines. In September 1962, the President called the White House Conference on Narcotic and Drug Abuse. In discussing the problems associated with narcotics and other drugs, the President said:

One problem meriting special attention deals with the growing abuse of nonnarcotic drugs, including barbiturates and amphetamines. Society's gains will be illusory if we reduce the incidence of one kind of drug dependence, only to have new kinds of drugs substituted. The use of these drugs is increasing problems of abnormal and social behavior, highway accidents, juvenile delinquency, and broken homes.

The abuses associated with the nonmedical use of barbiturates and habit-forming stimulant drugs were also considered in some detail in the final report of November 1963, of the President's Advisory Commission on Narcotic and Drug Abuse.

Mr. Chairman, your subcommittee now has before it S. 2628, a bill designed to deal with the problem of the illegal traffic in psychotoxic drugs such as barbiturates and amphetamines by regulating

1 United States v. Roseman, D.N.D. Calif. (Crim, No. 39,333) June 3, 1964.

the manufacture, compounding, processing, distribution, and possession of such drugs. The Secretary of Health, Education, and Welfare sent his report on this bill to you on July 20, 1964.

As you know, that report urges enactment of S. 2628, Senator Dodd's bill, with certain technical modifications. The bill would amend the Federal Food, Drug, and Cosmetic Act by establishing certain additional requirements and controls with respect to psychotoxic drugs to prevent their diversion from legitimate medical channels. The Secretary is authorized to exempt from the operation of the amendment any such drug when the controls are not necessary for the protection of the public health.

One of the inadequacies of the present law is that it must be established that drugs found in illegal channels have moved in interstate commerce before they become subject to Federal jurisdiction. Since drugs sold on the bootleg market are often packaged in fruit jars, paper sacks, envelopes, matchboxes, or cigarette packs, it is often difficult if not impossible to establish the interstate character of the merchandise.

The provisions of the bill before you, S. 2628, would apply to all psychotoxic drugs whether or not they enter interstate commerce. We believe that the regulation of interstate commerce in these drugs without the regulation of intrastate commerce would discriminate against and depress interstate commerce in such drugs.

Further, the present law does not provide suitable means for detecting diversions from legitimate channels. Manufacturers of these drugs are not required to keep adequate records of the production and distribution of such drugs, and many of them do not keep satisfactory records. This inadequacy in recordkeeping is found all the way down the distribution chain from the manufacturer to the retailer. Thus, wholesale quantities of drugs can be sidetracked into illegal channels with virtually no possibility of pinpointing the spot at which they were diverted by reviewing records.

S. 2628 would require manufacturers and others engaged in receiving or disposing of such drugs, except doctors, to keep a complete record of the quantities of such drugs they handle, and make these records available to our inspectors. The bill would forbid the disposal of these drugs except through legitimate channels and prohibit the unauthorized possession of such drugs if such possession is not for the personal use of the possessor or a member of his household, or for administration to an animal owned by him or a member of his household. This possession provision is not intended to be used to punish illicit drug users. Its purpose rather is to make it possible to deal with illegal purveyors of these drugs, such as peddlers and truck stops, where an actual sale cannot be proved but where an individual possesses such drugs which clearly are not for his own use.

In practice, Mr. Chairman, this bill would immediately place barbiturates and amphetamines in the category of psychotoxic drugs subject to its added controls. But it goes further: It authorizes the Secretary of Health, Education, and Welfare to decide what other drugs are in need of the same type of control and to classify them as psychotoxic drugs. Thus we would expect very shortly after enactment of the bill to classify such products as LSD25, and some of the tranquilizers which already are causing problems, as psychotoxic drugs subject to the safeguards of this bill. Experience shows that

as the psychotoxic agents now abused become more difficult to obtain, the underworld and the other groups that use them will find substi

tutes.

One reason that barbiturates and amphetamines constitute such a big problem today is that narcotics are under very stringent controls, making them very difficult to obtain for nonmedical purposes. In our view, Mr. Chairman, it is proper that these other drugs may be designated as psychotoxic by the Secretary without the necessity of seeking additional legislation each time a new psychotoxic drug shows up as a potential problem.

We do have some reservations, Mr. Chairman, about section 7 of the bill. This section would have the effect of requiring formal rulemaking procedures with plenary hearing before issuance of a regulation that would include under the bill's coverage any psychotoxic drug other than one containing a barbiturate or amphetamine. The type of rulemaking procedure proposed is not, in our view, the most desirable procedure for making the judgmental types of decisions that will be required here.

It will be our purpose, of course, to consult scientists outside the Government in arriving at the facts concerning any drug being considered for designation as psychotoxic, and we do not anticipate significant differences of opinion among scientists as to the physiological actions of these drugs.

The decision that the Secretary will be called upon to make will follow the determination of scientific facts and will be a decision as to whether, based upon the clinical properties of a drug, it is in the public interest to place it under the controls of this bill. Placing a drug under these controls would not bar it from the market; it would simply guard against the diversion to illicit channels of a drug potentially very dangerous to society. The tentative decision to classify a drug as psychotoxic would, of course, be published by the Department, so that all interested parties could offer their views.

We would also expect to use the conference method where appropriate to supplement this procedure, as we have done in other areas. As you know, Mr. Chairman, the executive branch is still studying the report of the President's Commission on Narcotic and Drug Abuse, and President Johnson has directed the several agencies of the executive branch which have an interest in this matter to take steps to bring the full power of the Federal Government to bear on the problem. On July 15, 1964, President Johnson stated:

Narcotic and other drug abuse is inflicting upon parts of the country enormous damage in human suffering, crime, and economic loss through thievery. The Federal Government, being responsible for the regulation of foreign and interstate commerce, bears a major responsibility in respect to the illegal traffic in drugs and the consequences of that traffic. That responsibility is shared by several departments of the Government and by a number of divisions, bureaus, and so forth, within them. I now direct those units to examine into their present procedures, to bring those procedures into maximum activity, and wherever necessary put into effect additional programs of action aimed at major corrections in the conditions caused by drug abuse. I desire the full power of the Federal Government to be brought to bear upon three objectives: (1) the destruction of the illegal traffic in drugs, (2) the prevention of drugs abuse, and (3) the cure and rehabilitation of victims of this traffic. Attention is called to the program described in the Report of the President's Advisory Commission on Narcotic and Drug Abuse.

For the purpose of coordinating the steps to be taken by the several units of the Government in this matter I designate Lee White of the White House staff to act as liaison agent between them, with instructions to implement the foregoing directive.