On pages 19, 20, and succeeding pages, there is some reference to the industry's contribution to educational programs, academic and other. Not included, of course, are promotional programs or advertising.

These, as you will see from the details, refer to such things as television and books. For example, a book I brought with me which was just received in the mail is one made available from another country and is on the absorption and distribution of drugs, consisting of a number of chapters written by experts. It is now available as a result of a symposium held by an association of medical advisers in the pharmaceutical industry. There are also many other examples, a few of which we have cited in these pages.

Now, finally, and beginning on page 22, we try to define the role of— and this is in response to your request in your letter, Mr. Chairmanthe Food and Drug Administration, or Government, the role of the pharmaceutical industry, and the role of the medical profession. We follow this development with some specific recommendations. Since there are only a few of the latter, I would like to read them quickly. We have supported a strong FDA to bring about some of the things we think it should do, and things it could do better, if it had the help that it sought, and if it had the help that we and others think it should have. Hence, you will find in your packet examples of statements made by the Pharmaceutical Manufacturers Association urging a strong Food and Drug Administration. One such statement appears in the booklet entitled "For a Stronger Federal Food and Drug Administration."

Another is exhibit No. 2, which I would request permission to have included in the record. It has been made available to you with our prepared testimony, and is entitled "Recruitment of Qualified Medical Personnel by the Food and Drug Administration."

Incidentally, Dr. Klumpp and I have previously testified to strengthening the Food and Drug Administration. Others before us have made similar pleas for a long time. I believe the PMA history of such support goes back for probably 10 years or more.

As an aside, if I may pause for a moment-I frequently think of the long history of relationship that develops among people who have had changing interests. This indeed is reflected here at the table of witnesses.

The three of us have worked closely together for years in Government and organizational work before we became a part of industry. We are still working together. Dr. Klumpp's path and mine have crossed for about 24 years. Perhaps he may not care to admit to so long a period but I will. Dr. Scheele and I and Dr. Klumpp have had mutual interests for a long, long time. And Dr. Beyer, Dr. Bambach, and Mr. Stetler also have interests of a somewhat similar nature, sometimes arising from research in schools, sometimes organizational work, and now, of course, all are identified with the industry.

This is the way it should be. That is why some of us feel it is helpful to all to have a strong FDA, strong not in terms of policing, but strong in terms of makeup and scientific help and other things. So also is it good for all of us to have a strong and scientically oriented industry, and obviously scientically oriented medical practitioners.

Pages 23 and 24 bring out some of the recommendations that we have made in the past and are prepared to make again. Very briefly, I would specifically direct these to your attention in some detail, Mr. Chairman.

Beginning on page 23, may I read, with a prefacing note, that the PMA has always been willing to work with the Food and Drug Administration, and with other regulatory and legislative bodies, as well as with medical and other scientific bodies. We rather cherish our past memories of such cooperation, those that we now enjoy and those we hope to have in the future.

In our opinion, there are certain steps which could be taken by the Department of HEW, and FDA, which would make our joint efforts more fruitful and which would provide greater measures of public health protection. The first is a recommendation contained in the October 1962 Report of the Second Citizens Advisory Committee. In that report the Committee recommended that the Secretary of HEW establish a National Food and Drug Advisory Council, modeled after the various councils to the National Institutes of Health. Such a council would provide opportunities and a forum for an exchange of views on current drug and food problems among the scientific community, the regulated industries, and the Food and Drug Administration. Such a body should encourage better understanding, confidence, and cooperation, between these mutually interested bodies.

In addition, we believe scientific advisory panels to the FDA should be established on matters relating to new drugs. The FDA decision on scientific questions is becoming increasingly difficult to make as the questions themselves become more and more complex. Therefore, the creation of impartial advisory panels of outside experts to whom the FDA or the manufacturers may elect to refer difficult issues on the safety and effectiveness of new drugs would be in the public interest.

I would say, as a former secretary of the old AMA Council on Pharmacy and Chemistry and later as an editor and publisher of medical journals, I well knew the need that large bodies have for consultation, not just a few, not a few dozen, but hundreds.

For example, when I was editor of the Journal of the American Medical Association, we had card files of about 1,200 individuals to whom I could turn with questions concerning papers or inquiries that we had received. And incidentally, these consultants changed every year. New ones, with new information came along. Some, we felt, may have outlived their period of greatest usefulness in this activity. This is the kind of scientific world that exists today. It must be fluid for all.

The third recommendation asks that a council for scientific review be established to provide an appeal mechanism, for the review of drug evaluation problems. As you know, there often are considerable differences of opinion over the usefulness of drugs, the safety of drugs, whether they should be continued in use or whether they should be placed on the market. Very often the decision should be made not administratively, really, but rather on the basis of medical needs. And here is where there often is a need for a body to which an appeal can be made by any interested party for an advisory decision. On purely legal matters, we feel the Food and Drug Administration sometimes

has to be challenged in the courts. But on scientific issues, there is no means for formal or effective appeal. And yet in matters involving the toxicity and efficacy of drugs, the agency is called on to administer not only the laws of man, but the laws of science as well. If the FDA makes a ruling or an interpretation on a scientific point, it is almost certain to stand, even though the ruling is considered unsound in the opinion of competent scientists.

As an aside I might add that from time to time such differences of opinion have a reason. I might also mention that the manufacturers of pesticide chemicals and color additives have such a means of appeal. In the statement on page 24, you will find a little more detail about it, and why we feel that such a mechanism should exist for the drug field as well.

Finally, recommendation No. 4. We believe that there is a need for establishing a system for recording, correlating, evaluating, retrieving, and disseminating information dealing with drug research and use. At the present time, FDA receives masses of drug information from manufacturers and from innumerable other sources. The filing of information, for example, on new drugs that are under investigation, the filing of information that accompanies the NDA, provides a mass of material that sometimes could be helpful if shared in one way or another. This information now may be neither evaluated nor shared in any systematic way with the pharmaceutical industry. This is not said in the way of criticism but as a matter of fact. So with respect to research information, we in the industry are on a one-way street. The industry reports to the Government, but there is no effective method of sharing information on Federal drug research efforts with the nongovernmental scientists. Unless national security or other confidential factors dictate otherwise, we think such information should be made available periodically.

On the bottom of page 24 and page 25, there are a number of conclusions with respect to other specific recommendations. I will skip, in the interest of time, the conclusions preceding the recommendations. But I would like to read these other recommendations.

The fifth recommendation calls for the establishment of a joint Government-Industry Board to advise the Commissioner of Food and Drugs concerning an adequate system of reporting on the safety and efficacy of drugs.

The sixth asks for the periodic publication of detailed reports on medical research projects supported by the Federal Government.

The seventh would require improved communication between FDA and individual companies and the PMA on regulatory matters, including plans for new regulations.

I would say also, to supplement this, Mr. Chairman, that the forthcoming report of the Commission on Drug Safety will indicate a deep. awareness of many of the problems that have been raised in this statement. It will probably make a number of recommendations that are somewhat in line with some of those that I have today discussed in spirit if not in substance. You will see in this report a deep plea, for example, that careful consideration be given to any action which might remove from the medical profession or prevent the medical profession having available a needed drug, because of some temporary uncertainty that exists over its use, or perhaps even worse, some hysteria that is momentarily raised because of headlines.

In addition, I believe the Commission will find it sees nothing wrong with better communications, even if this means seeking advisory help between bodies with mutual interests. This would specifically mean Government and the drug industry as well as Government and medical bodies.

before you.

Mr. Chairman, we appreciate the opportunity to appear I hope the summary that I have presented on behalf of the three witnesses and the Pharmaceutical Manufacturers Association offers some additional information. We will be pleased to answer your questions now but are hopeful that if you have subsequent questions we will have the opportunity to try to serve you by answering them by correspondence or otherwise. And all of us before you today are prepared, Mr. Chairman and members of the committee, to try to answer your questions.

Thank you.

(Prepared text follows:)

STATEMENT OF DR. AUSTIN SMITH, PRESIDENT, PHARMACEUTICAL MANUFACTURERS ASSOCIATION

Mr. Chairman and members of the subcommittee, it is a privilege to appear before you today to present the views of the Pharmaceutical Manufacturers Association on the important inquiry which the subcommittee has undertaken. My name is Austin Smith. I am president of the Pharmaceutical Manufacturers Association. For some years I was editor and managing publisher of the Journal of the American Medical Association and of other scientific publications sponsored by that association. I am chairman of the board of directors of the U.S. Committee and Council Emissary of the World Medical Association, and have served as executive editor of the World Medical Journal.

I also have served in various official capacities for bodies such as the U.S. Pharmacopeia, medical and other organizations, universities and scientific societies. I also am a member of a number of professional and scientfic associations.

I received my degree, M.D., C.M., in 1938 from Queen's University, Ontario, and a master's degree in medical science from the same university in 1940.

I am accompanied by Dr. Theodore G. Klumpp and Dr. Leonard A. Scheele. Other representatives of the industry are also present to assist, if necessary, in answering questions.

Dr. Klumpp is president of Winthrop Laboratories and a member of the board of directors of the Pharmaceutical Manufacturers Association. He was graduated from the Medical School of Harvard University in 1928 and practiced at various hospitals in Boston, Cleveland, and New Haven, where he was on the faculty of the Yale University Medical School.

In 1936 he was appointed Chief Medical Officer and in 1938 became Chief of the Drug Division of the U.S. Food and Drug Administration. He served in that capacity until 1941. He was vice president of the U.S. Pharmacopeia from 1950 to 1960 when he was reelected to a second term running to 1970. He also served as chairman of the Medical Service Task Force of the second Hoover Commission and is presently a member of the Medical Advisory Committee of the Department of Health, Education, and Welfare's Office of Vocational Rehabilitation.

In addition, he was Chairman of the Office of Defense Mobilization's Task Force on Employment of the Handicapped. He is a member of the Panel on Aging of the Department of Health, Education, and Welfare, and Chairman of the Subcommittee on Physical Fitness.

He is a director of the U.S. Committee of the World Medical Association, a director of the American Heart Association, and chairman of its committee on rehabilitation, a member of the American Medical Association and a fellow of the American College of Physicans and the New York Academy of Medicine.

Dr. Scheele is senior vice president and a member of the board of directors of Warner-Lambert Phamaceutical Co., Morris Plains, N.J. He is responsible for the direction of Warner-Chilcott Laboratories Division which produces pharma

ceutical products and for Warner-Lambert Research Institute in which all corporate research is centered. Dr. Scheele was a career officer in the U.S. Public Health Service for 23 years. Prior to 1956 he was engaged primarly in medical and public health administration in various service programs.

His assignment in the U.S. Public Health Service from April 1948 to August 1956, was Surgeon General. His last assignment before becoming Surgeon General was Director of the National Cancer Institute. He was particularly active in the postwar expansion of activities, research and training, of the National Institutes of Health.

During World War II, Dr. Scheele was detailed to the Medical Department of the Army, served 34 years overseas in a variety of military, Government, civil affairs assignments in Africa, Italy, and northwest Europe. In addition to a number of honorary degrees he has received the following: Bachelor of arts from the University of Michigan; M.D. cum laude from Wayne State University School of Medicine.

Activities: Chief delegate of the United States to the World Health Assembly (1949-51); President of the Assembly in 1951-56; chief delegate of the United States to Pan-American Sanitary Conferences (1948-52); President of the Fourth International Conference of Tropical Diseases and Malaria (1948).

Memberships: American Medical Association, New Jersey State Medical Society, Morris County Medical Society, District of Columbia Medical Society; fellow of Public Health Association; diplomate of board of preventive medicine; Association of Military Surgeons of the United States (president, 1954); vice president and member of the board of National Fund for Graduate Nursing Education; trustee of American Fund for Dental Education; visiting lecturer in public health, Harvard School of Public Health; special lecturer in public health, Georgetown University.

In our appearance today we represent the Pharmaceutical Manufacturers Association, a trade association composed of about 140 leading manufacturers of pharmaceutical products, accounting for more than 95 percent of the Nation's total output of prescription drugs.

We respectfully invite attention to the historical fact that there has been no important development in the field of effective drug therapy for more than a quarter of a century where members of PMA have not played a significant role either in the discovery of the agent or in defining its utility and making it readily available to the medical profession.

Reviewing the subcommittee's work to date, we have been impressed by the wide range of subjects it has considered. However, in accordance with your letter of March 16, the association's statement has been limited primarily to a discussion of the role of the Food and Drug Administration, the pharmaceutical industry, the Pharmaceutical Manufacturers Association, and individual firms, in helping to assure the safety of drugs.

In presenting the comments of the pharmaceutical industry on this complex and important subject I shall refer briefly to:

I. The role and contributions of the pharmaceutical industry.

II. Programs of the Pharmaceutical Manufacturers Association related to drug safety.

III. Activities of individual firms to increase drug safety.

IV. Education and research concerning drugs.

V. The role of the Food and Drug Administration.

VI. Conclusion and recommendations.

In an effort to limit somewhat the length of this statement and to supply important background information, a number of exhibits, identified in the statement, are attached. A packet of related publications prepared by the PMA has also been assembled for each of the members of the subcommittee.

I. THE ROLE AND CONTRIBUTIONS OF THE PHARMACEUTICAL INDUSTRY The manufacturers of prescription drugs invent, develop, manufacture, and distribute products which are designed to prolong and save lives. These prodnets affect the basic functions and structures of the human body. They combat the fiercest enemies of the health of humans. With such a role, a prescription drug inevitably involves risks and is the subject of differences of opinion as to its effectiveness. Indeed no drug is safe or effective in absolute terms.

It requires profound wisdom, judgment, skill, and integrity to decide when and under what conditions a drug should be made available or taken away from the physician for use in his practice. Although the burden of this decision is