the people for whom previous treatments have failed, certain kinds of people will still be considered investigational. The issue here

Mr. ROGERS. Wait a minute. If it is good to say we don't know enough about some of them and it ought to be investigational, you are talking about all of this control, why should that not be included in the new drug approach, too?

Dr. JAFFE. The nature of approving NDA's, and this has been the case for, I believe, almost 10 years, is that one approves a drug not in toto but for specific circumscribed uses, thus methadone is now totally approved for analgesia. It is even approved for cough medicine and perhaps in some instances other specific kinds of things.

NDA does not mean a drug is efficacious for everything one might use it for. Indeed, if somebody came up with an idea that a new drug which is well established such as penicillin were good for something nobody thought of before, even that well established drug would now require an IND first.

Mr. ROGERS. Let me ask you this. Then are you leaving the drugs in the drug stores for cough medicine?

Dr. JAFFE. We have talked to the manufacturer about this. We feel that the situation has gotten to the point that we would like concomitantly with introduction of an NDA to work with the manufacturer to remove most of the other forms of methadone from the drug list.

Mr. ROGERS. The proposal is that you take it all out of the pharmacies, don't you?

Dr. JAFFE. We will be taking most of it out.

Mr. ROGERS. Are we or are we not?

Dr. JAFFE. The issue is that they will put forth an NDA proposal and there will be lots of time for everyone to make comment. Now, what will happen at the end of that, obviously, we can't predict. Mr. ROGERS. But I understand it is being proposed to take it all out of the pharmacy.

Dr. JAFFE. Yes, sir, that is the initial proposal.

Mr. ROGERS. Therefore, you are saying we are not permitting what has normally been approved and accepted as safe and effective for a cough medicine.

Dr. JAFFE. It is not that it will no longer be approved; it is that it will no longer be available.

Mr. HASTINGS. Will the gentleman yield?

Mr. ROGERS. Yes.

Mr. HASTINGS. If I understood correctly, Dr. Edwards indicates that the cough medicine may very well remain in the pharmaceutical drug stores.

Dr. JAFFE. That is still not clear. That is correct.

Mr. HASTINGS. With only one exception.

Mr. ROGERS. I understood in the pharmacies in the hospitalsMr. HASTINGS. I think in the cough medicine there may be an exception.

Dr. JAFFE. The drug for analgesia will be left in the pharmacies. Mr. ROGERS. The last sentence on page 10 indicates a necessity for some authority of Special Action Office over law enforcement provisions where it is tied in very closely here with maintenance.

Dr. JAFFE. I don't think that that was the intent to imply that, sir. Mr. ROGERS. In other words, you don't think there is any point in having any control there?

Dr. JAFFE. Well, it was not the intent to create an office with control of law enforcement. We have been acting as a mediator, if you will, as we try to work out a smooth lineup of responsibilities of the Bureau of Narcotics and Dangerous Drugs and the Food and Drug Administration.

Mr. ROGERS. I am sorry, I said page 10; it is page 9. "FDA and BNDD have complementary roles which must interdigitate if we are to maximize the efficacy of treatment and minimize potential problems," which I would think builds the case rather forcefully for some say-so by your office to make sure that they interdigitate correctly.

Dr. JAFFE. We have been working with the Bureau of Narcotics and Dangerous Drugs and FDA.

Mr. ROGERS. I was thinking in setting up authority for you to make sure that you could do this under authority of law.

Dr. JAFFE. Well

Mr. ROGERS. I guess you have no strong objection if the Congress does

that.

Dr. JAFFE. I have learned that my strong objections don't hold a great deal of weight, Mr. Chairman.

Mr. ROGERS. Well, they do in this committee.

There is a vote on. I think we have gotten generally the picture of what is being contemplated. There will be assurances of additional time so the Congress could act if we think it is not sufficient.

If you would submit any studies you think might be helpful to the committee in this regard, we would be pleased to receive them.

Dr. JAFFE. I want to emphasize that in the opinion of all concerned, NDA does not mean that we have an answer. It is a small, partial answer that we think should be available to those who need it, sir. Mr. ROGERS. Thank you, Dr. Jaffe. We appreciate it. The committee stands adjourned.

(The following statements and letters were received for the record:)

STATEMENT OF JAMES R. KIMMEY, M.D., EXECUTIVE DIRECTOR,

AMERICAN PUBLIC HEALTH ASSOCIATION

Mr. Chairman and Members of the Committee:

I am Dr. James R. Kimmey, Executive Director of the American Public Health Association. Our Association, with its 52 affiliated State organizations, comprises a membership of 52,000 health workers in some 30 disciplines whose daily efforts are devoted to improving the health status of Americans. Not surprisingly, the Association has often taken official notice of the growing problem for the nation represented by drug abuse. Thus we are pleased to be invited to appear before this Committee to present our views on the various proposals for intensifying, and improving the coordination of, drug abuse control programs in the United States.

In our opinion, the problem of drug usage in this country poses an impending national disaster. It demands new priorities, greatly strengthened efforts, and reorientation of programs. Drug abuse is a disease, and in the United States in 1971, it is an epidemic disease. It is an epidemic disease that cuts across social and generational lines to strike at or near the lives and health of millions of families. It is not, as it once was, a disease affecting a hard core fringe element of the society. The day when a "junkie" was a pariah are gone. It is not, as it once was, a disease that involves a small number of specific drugs. The suburban housewife who uses an amphetamine to get "up" in the morning and a barbiturate to "calm down" at night is equally a drug abuser with the

heroin addict in a "shooting gallery" in the inner city. Any solution to the problem of drug abuse in the United States must encompass this breadth of definition if it is to succeed. Narrowing the definition to only those who use the so-called "hard drugs" fosters punitive and rehabilitative approaches to the exclusion of badly needed control on production and public education.

In viewing any epidemic disease, the public health oriented individual looks not only to the effects of the disease once it is manifest, but also to the vectorsthe agents that carry the disease and the causative organism. Thus it is that public health programs direct themselves not only toward the treatment of manifestations but also concern themselves with control of the vectors and eradication of the causative agents. As it is with malaria, tuberculosis, or venereal disease, so it should be with the drug abuse problem. Treatment and rehabilitation programs, such as methadone maintenance, are one essential part of a total societal program for dealing with this problem. "Vector control" in this case encompasses stringent enforcement of laws which punish those who sell such drugs. A less obvious but important aspect of "vector control" is the problem of educating prescribers of drugs to the danger of over-prescription or inappropriate prescription of drugs with a dependency hazard. Finally, control of the causative agent in this case is a complicated procedure involving both sensitive negotiations with foreign governments who permit the production of the raw materials for the opium family, and regulatory control of domestic production of dangerous drugs which are produced in quantities far exceeding the therapeutic need. Undergirding the entire control program must be continued research activities relating to the drugs themselves and the dependencies they evoke, as well as public education activities which stress the price at which pleasure is sought by the drug user.

In support of these general concerns, the American Public Health Association has made several specific recommendations:

1. Control of importation into the United States of drugs of all types and strict exclusion of illegal drugs;

2. Action against illegal distributors of drugs especially organized criminal groups;

3. Elimination of surplus production in excess of prescription demand: 4. An attack upon unnecessary drug demand through education in the schools, and elimination of advertising which stimulates the excessive use of drugs:

5. Encouragement of further experimentation with organized maintenance programs using methadone and similar compounds, subject to appropriate supervision and evaluation;

6. Use of the services of former drug addicts in assisting with the rehabilitation of others; and

7. Encouragement of medical care facilities to develop adequate staff and equipment to render emergency and post emergency care.

One of the major weaknesses to date in mounting an effective program to control drug abuse has been the fragmentation of responsibility for various aspects of a total approach. Many of the programs that we feel would be desirable exist, but are placed in a variety of Federal, State and local jurisdictional bodies. This type of fragmented activity, so characteristic of our approach to health problems. is a continuing hinderance to effective solutions. The proposal for creation of a Special Office for Drug Abuse Control as single focus for coordination for Federal efforts in the drug area is a reasonable and proper one, and is directed toward the fragmentation problem. In addition, the increased visibility of attempts to solve the problem attained through such an office has value.

A recognition of this need for stronger coordination at the policy, planning, and administrative levels is expressed in a number of specific bills that have been introduced in the Congress. In our view, each of these bills has considerable merit and differ only in relatively minor areas. Generally, H.R. 9264. the Special Action for Drug Abuse Prevention Act provides the most flexible yet specific approach to the coordination problem of any of the proposals. There is. however, one area of exclusion in H.R. 9264 that should be carefully considered by the Congress. In SEC. 5. (b) and in subsequent Sections law enforcement activities and legal proceedings are excluded from the authority of the Director of the Special Action Office for Drug Abuse Prevention. Although we recognize that the technical and legal aspects of law enforcement are properly beyond the purview of the Director, we would challenge complete exclusion of law enforce

ivities as proposed in H.R. 9264. If one is to approach drug abuse pre

vention and control as a health problem, then the participation of the healthoriented director in matters of policy, planning and coordination of enforcement activities seems to us essential. As long as society judges the sick individual who is a drug abuser as a criminal, the standards applied in his arrest, detention, and treatment while in the jurisdiction of legal authorities is a health matter. The law enforcement phase of the total drug abuse program should be viewed as such a phase of a total program-and should be coordinated with other activities such as production control, public education, management of acute crises, and rehabilitation of the addicted individual. We would hope that the exclusion of law enforcement activities from any oversight by the director of the Special Action Office for Drug Abuse Prevention would be reconsidered and that he would be given a definite and continuing coordinative role that would allow him to place law enforcement in perspective with other, ultimately more important approaches to this serious national problem.

We urge your favorable consideration of the important initiative toward a more rational program for drug abuse control as suggested in H.R. 9264. The problem is not simple; but the current approach is needlessly complex. Better coordination will not, of itself, solve the drug abuse control problem, but it would represent a significant step towards focusing resources that are now directed diffusely.

STATEMENT OF THE AMERICAN ASSOCIATION OF COLLEGES OF PHARMACY

INTRODUCTION

This statement is submitted by the American Association of Colleges of Pharmacy to support bills which establish drug abuse prevention and education programs for servicemen and their dependents.

The American Association of Colleges of Pharmacy consists of 74 schools and colleges of pharmacy. All are nationally accredited. Seventy-three of our member schools are located in 44 States and the District of Columbia; the remaining school is in Puerto Rico. More than 2,000 full-time and part-time teachers are engaged in the instruction of approximately 19,000 undergraduate and 2,100 graduate students.

The curriculum leading to the professional degree in pharmacy requires a minimum of five academic years. Two schools offer only a six-year curriculum leading to the professional degree, doctor of pharmacy, and nine others offer the longer program on an optional basis, in addition to the minimum program. In the five-year program, at least three years of work in the professional subjects are required in addition to the two-year basic science program. In the six-year curriculum, four years are mandatory beyond the two years of basic science.

Thus, today's pharmacy graduate is a thoroughly educated drug scientist.

Pharmacy schools have been actively engaged in organized drug abuse education programs for the general public for at least five years. Many individual faculty members and students were involved in drug education programs long before that date, but on a nation-wide basis, most of the 74 schools have been involved since 1966.

HISTORY OF PHARMACY SCHOOL DRUG ABUSE EDUCATION

We attach an article from the September 1967 Journal of the American Pharmaceutical Association (Attachment A) to show how some of our schools started their drug education programs for the public.

Since 1967, pharmacy students and faculty members have conducted thousands of information programs for college students, high school and junior high school students. PTA's, civic clubs, and other groups. We believe several hundred thousand people have learned something about drugs through these programs.

We do not believe our member schools have done enough. We do not believe that pharmacists have done enough. We believe we can do more, particularly with regard to preventing drug abuse in the Armed Services.

EXAMPLES OF CURRENT PHARMACY SCHOOL DRUG ABUSE PROGRAMS

Two of our deans have prepared statements describing the drug abuse education programs, courses, and projects at their schools. These are representative

activities at most schools of pharmacy. The deans are: Arthur E. Schwarting. Ph.D. (Attachment B), School of Pharmacy, University of Connecticut, and President of the American Association of Colleges of Pharmacy, and George P. Hager, Ph.D. (Attachments C, D, E and F), School of Pharmacy, University of North Carolina, and member of the National Health Resources Advisory Committee.

This Association urges that the subcommittee consider these articles as evidence of the ability of many young pharmacists to participate in drug abuse education programs in the military. If there are insufficient pharmacists available in the Armed Services, the Association suggests that a special call be made under the Selective Service Act to obtain the pharmacists to do the job. The Association believes that many of our recent graduates are now serving in the Armed Services. They have participated in drug abuse education pragrams and have a strong desire, as patient-oriented professionals, to assist the public in any way possible. We suggest that the subcommittee request the Department of Defense to identify these individuals and commission them for the purpose of mounting drug information programs. Combined with sociologists, psychologists, physicians, psychiatrists, and law enforcement personnel, these pharmacists could assure the military of proper informational programs. Pharmacists are the only health care professionals whose exclusive specialization is in the health area of drugs, including drugs of abuse.

ATTACHMENT A

ON THE CAMPUS. . . DRUG ABUSE PROGRAMS*

(By Dale W. Doerr, Hugh F. Kabat, William J. Sheffield and William J. Skinner)

Pharmacists are aware of the current publicity being devoted to drug abuse on the nation's campuses. Newspapers, magazines and other media abounded with reports on drug misuse among America's college students.

Unfortunately, these reports rarely give an objective appraisal-a true picture of the situation. The press has a tendency to magnify a provocative problem out of all proportion, and this overzealous coverage seems especially evident where drug abuse on the campus is concerned. From any press reports on the subject, the casual reader would have to conclude that glue, "pep pills," cough syrups and LSD are as much a part of the college curriculum as Western civilization or English literature, as physics or chemistry.

To a degree, the college drug abuse problem has suffered from such journalistic exaggeration. But only to a degree. Careful studies have shown that drug abuse does exist in many, if not most, American colleges and universities. At this time the problem appears to be confined to relatively few students in any one institution, but if sensational press reports continue to be the only communication to college students on the subject, the problem will not be confined much longer. Experience has shown that drug abuse is a highly contagions disease and the kind of publicity the problem has been getting-publicity that often makes drug abuse sound glamorous and exciting—can only help spread the contagion.

To combat the campus drug abuse problem effectively, somebody has to talk to students about it without glamorizing it-without making it sound like the "in" thing to do. Perhaps what is needed is a balanced drug abuse education program for college students which explains in an objective manner the benefits of legitimate, medical drug use and the dangers of illegitimate, abusive drug use. This paper describes a unique method of providing such educationa promising new program in which pharmacy students play the key role.

1 Attachments D, E, and F may be found in the committee's files. Attachment D "Better Living Thru Chemistry," 1971 USAF Pharmacy Seminar, Brooks AFB, Texas (Capt. Dean Peyton and Capt. David Stevenson). Attachment E-"Teacher Drug Abuse Education Project-Proceedings," July 13-17. 1970; July 27-31, 1970; August 10-14, 1970. Sponsored by School of Pharmacy, University of North Carolina, and North Carolina Department of Public Instruction. Attachment F-"Kids 'n Drugs" by Leonard Berlow, School of Pharmacy, University of North Carolina, Chapel Hill, N.C.

*Presented before the Academy of General Practice of Pharmacy at the meeting of the American Pharmaceutical Association, in Las Vegas, Nevada, April 10.