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source. It is inconceivable that a practitioner would clutter his office with all this labeling in loose form.
Compilation of a Drug Labeling Compendium will be a difficult task. The central issue, from FDA's standpoint, is how to abbreviate the package insert without compromising public health protection. If we are to condense such labeling, it will still have to adequately reflect current knowledge about the drug. However, we believe that an objective summary, approved by FDA, would be preferable to a package insert which is never read. Also, we believe it will be possible to group several drugs into one category with a general summary covering all the drugs included in the group.
Another pressing consideration is whether or not the package insert should be completely done away with in view of the Compendium, or merely the requirement of distributing it with each package. As this complete labeling is the basis of a new drug approval, we do not recommend that such labeling be completely eliminated. Additionally, the package insert type information should remain available for those persons, such as clinical researchers, in need of such exhaustive data. In a few instances, it will probably not even be possible to provide for an exemption from distributing the “package insert.” For example, we believe it is essential to have complete, unabridged information actually accompanying the package when such information may be needed by the physician at the actual time of administration.
Another factor which prompts our endorsement of a Compendium is that it will list all drugs, thereby increasing the physician's prescribing range. And, of course, pricing information could be included as a supplement to the Compendium thereby fostering more economic prescribing. However, listing in the Compendium could be construed as Governmental approval of a product. As we have stated on numerous occasions, FDA is not presently in a position to guarantee the quality of all drugs on the market, although we are constantly striving toward this goal. Nor could we assure the effectiveness of a drug listed in the Compendium. As you know, the NAS/NRC review of effectiveness of drugs marketed between 1938 and 1962 is not yet completed. However, if this review results in the removal of any drug from the market, it would likewise be removed from the Compendium. Thus, the Compendium would if adopted, have to grow with the FDA as we draw closer to our ultimate goal of complete assurance. In this context we would recommend quarterly supplements be published in order to keep the Compendium current.
With sufficient funds (approximately $5 million per annum) the FDA could publish a Compendium. FDA could also provide that listing in the Compendium would satisfy the requirements of full disclosure. Although the project could thus be achieved without increased authority, it would not be the most advantageous manner in which to proceed. As the drug industry will be relieved of the cost of “package inserts” by this proposal, it would be appropriate to shift the cost of the Compendium to that industry. This, of course, would necessitate legislation. Additionally, legislation would be desirable to clarify the scope and purpose of the Compendium and to realign some present provisions of the Act in greater conformity with the Compendium concept.
A final comment on this subject-we believe that increasing access to the complete labeling of prescription drugs is in itself enough to justify publication and distribution of a Drug Labeling Compendium. Additionally, the Compendium would list generic products together with their well-known trade name counterparts, thereby facilitating the economic prescribing of generic drugs and increasing the physician's familiarity with presently complex drug nomenclature.
Mr. Chairman, we appreciate this opportunity to clarify our position with respect to marihuana.
As evidenced by the attention given by representatives of Government, the press, and the professions, it is plain that the increasing use of marihuana is a matter of national concern. I am aware, Mr. Chairman, that statements attributed to me, but which I did not make, have caused additional concern. Let me clarify the record in this regard at the very outset.
I did not say that I would not object to my daughter smoking marihuana.
With your permission, Mr. Chairman, I would like to call your attention to one point which arose as the result of an erroneous news dispatch from Minne
apolis on October 17. I was reported to have stated that I would not object any more to my daughter smoking marihuana than if she drank a cocktail.
The news dispatch was not correct and Mr. Julius Frandsen, Vice President and Washington Manager of United Press International, has written me a letter acknowledging error by UPI. With your permission, I would like to insert a copy for the record.
Mr. Chairman, I think the press recognizes the importance of the problem marihuana presents to society and makes every effort to provide the Nation with the best information available.
My remarks concerning marihuana-in Minneapolis and elsewhere have always been in response to questions from the press. In every instance, I have made it abundantly clear that marihuana has been and still remains under the jurisdiction of the Bureau of Narcotics of the U.S. Department of the Treasury. It is often erroneously assumed that the Food and Drug Administration, which administers the Drug Abuse Control Amendments, has jurisdiction over not only the controlled drugs—the amphetamines, barbiturates, and hallucinogens—but marihuana as well. Our Agency has made every effort to clarify the differences wherever possible.
Now let me make several points about marihuana. First the shocking growth and use of marihuana has been so rapid that none of us in government, in medicine, or the legal profession has been able to counter it effectively.
The use of marihuana in this country and the rest of the world, has a long history, of course. In the United States, “marihuana” refers to any part of the plant, or an extract such as the resin, which induces changes in physical perception and in psychological reactions. These physical and mental effects will vary in the individual marihuana smoker, depending on four major factors :
The circumstances in which the drug is used;
The user's previous experience with marihuana. The most common reaction to marihuana is development of a state of mind in which ideas seem disconnected, uncontrolled, and freely flowing. Perception is disturbed, minutes seem to be hours, and seconds seem to be minutes. Space may be broadened, and near objects may appear far away. When large doses are used—doses generally heavier than normally used in this country-extremely vivid hallucinations may occur. With such large doses, panic and a fear of death may make the experience highly unpleasant.
Gentlemen, what I have just told you about marihuana is a resume from one of the most respected textbooks on drugs in this country. It is the third edition of the Pharmacological Basis of Therapeutics by Louis S. Goodman and Alfred Gilman. I refer you to pages 299 and 300 of this volume.
It should be made clear, however, that no one in the scientific or medical communities is satisfied with the level of knowledge we have concerning marihuana and similar drugs. As I have stated on several occasions, there is still much research to be done.
For example, the chemical composition of marihuana has not been fully determined, although what seems to be the plant's most active ingredients have been isolated and synthesized. Scientificaly controlled marihuana studies of varying lengths have not been conducted on animals or humans to determine effects on body tissue and metabolism, or neuromuscular response, and on psychological, and cultural reasons for marihuana use, especially among our young people. The number and characteristics of marihuana users in the United States are virtually unknown, and paths to such use are unexplored.
Mr. Chairman, there are a number of studies that are being conducted under the auspices of the National Institute of Mental Health. I would like to deposit with the Committee at this time a recent listing by the NIMH of their marihuana research and related grant activities. You will notice that underway are several projects on the sociology of marihuana usage, the metabolism of marihuana in man and animals, and patterns of acquisition of the drug. Gradually, we will be able to construct a clearer picture_based upon hard, scientific facts of this drug, its short and long-term effects, its full identity, and the ways it can and cannot be used by man.
Meanwhile, our enforcement efforts in the Food and Drug Administration as well as in the Bureau of Narcotics must continue. The enforcement strategy of the FDA is to concentrate on those who engage in the illicit manufacture, distri
bution, and sale of large quantities of those drugs which are abused by some members of our society. This was the position advocated by the Department of Health, Education, and Welfare. This was the position adopted by unanimous vote of the Congress in enacting the Drug Abuse Control Amendments of 1965.
In my opinion, it has worked well.
As you know, Mr. Chairman, the Drug Abuse Control Amendments, which we carry out, include a class of drugs called the hallucinogens. Among these drugs are lysergic acid diethylamideor LSD—peyote, mescaline, psylocibin, and others, such as DMT and STP, which have recently come upon the scene. Since the establishment of our Bureau of Drug Abuse Control, in February of 1966, we have conducted over 2,000 criminal investigations. A third of these have involved the hallucinogens. Marihuana has been offered for sale or seized in nine out of every ten investigations by our BDAC men following the hallucinogen leads.
Our agents, Mr. Chairman, have moved in on these cases swiftly but with a good sense of who has jurisdiction. BDAC agents in Dallas recently seized 1,000 doses of LSD. At the same time they seized approximately 100 pounds of marihuana, which they turned over to Bureau of Narcotics agents. At New York's Kennedy International Airport, BDAC agents, again working on an LSD case, seized not only a quantity of that drug but about 230 pounds of marihuana as well, which was turned over to local police and agents of the U.S. Customs Service. There are countless instances of marihuana appearing together with the hallucinogens under our jurisdiction. Our agents, working in close cooperation with other Federal agencies and with the excellent cooperation of State and local law enforcement agencies, can account for 931 arrests to date. Sixty percent of these arrests involved the hallucinogens. And, as I have indicated in both the investigational as well as the arrest stages—marihuana is usually present.
The Food and Drug Administration and the Treasury Department's Bureau of Narcotics have been cooperating in dealing with this problem. There is a formal working agreement between the Bureau of Narcotics and our Bureau of Drug Abuse Control which provides for a close working relationship between our agents in the field as well as our staffs in Washington.
From this brief bit of history let me point out a rather significant anomaly in the penalties with respect to the two hallucinogens, LSD and marihuana. During the past year and a half I have become personally aware of the problem as FDA's Commissioner. For example, our agents may find two individuals in the same room, one possessing LSD-an extremely dangerous drug—and the other possessing marihuana. Our BDAC agents would seize the LSD under the executive seizure provisions of the Drug Abuse Control Amendments, but the person possessing the drug would not be subject to prosecution under the Federal statute. His companion, however, would be taken into custody and be liable to a felony conviction under the laws governing the possession of marihuana, a drug which is less potent than LSD. This is why I consider the penalties to be inconsistent. We find at our Agency, that this inconsistency prevents full and effective protection of the public interest in the matter of abused drugs of any kind. We believe that no useful purpose is served by making a felon of the individual who abuses the dangerous drugs.
Let me emphasize again that I have never advocated the legalization of marihuana. Rather, I have raised the question of the severity of the penalties attached to possession of marihuana and I suggest that the Congress might also wish to review these penalties in the light of enforcement experience throughout local, State, and Federal Governments and as the results of drug research may dictate.
Thank you. I will be happy, Mr. Chairman, to answer any questions you or other Members of the Committee may have.
Senator NELSON. The hearing is adjourned.
COMPETITIVE PROBLEMS IN THE DRUG INDUSTRY
WEDNESDAY, NOVEMBER 15, 1967
Washington, D.C. The subcommittee met, pursuant to recess, at 10 a.m., in room 318, old Senate Office Building, Senator Gaylord P. Nelson (chairman of the subcommittee) presiding.
Present: Senators Nelson and Hatfield.
Also present: Benjamin Gordon, staff economist; James H. Grossman, minority counsel; Susan H. Hewman, research assistant; and William B. Cherkasky, legislative director, staff of Senator Nelson.
Senator NELSON. The meeting of the Subcommittee on Monopoly of the Senate Small Business Committee will come to order.
Our witness this morning is Dr. William Apple, executive director of the American Pharmaceutical Association.
Dr. Apple, the committee is very pleased to have you appear this morning. We appreciate your taking the time to come here. The chairman is aware of your distinguished background in the State of Wisconsin and here on the national scene, and we appreciate your contribution to these hearings.
You may proceed to present your testimony in any way you see fit and I trust that you have no objection to the Chair interrupting you from time to time with questions relating to your statements while you are proceeding through your testimony? STATEMENT OF WILLIAM S. APPLE, PH.D., EXECUTIVE DIRECTOR,
AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, D.C.;
Mr. Chairman, we have with us Mary Lou Andersen of Wilmington, Del., who is our second vice president. Mrs. Andersen, would you please stand ?
Senator NELSON. Welcome to the committee.
Dr. APPLE. And Max W. Eggleston of Waverly, Iowa, who is a member of our board of trustees and president-elect.