Mr. FOUNTAIN. I am happy to note that in the statement which you prepared for presentation before the Subcommittee on Reorganiza tion and International Organizations headed by Senator Hubert Humphrey, you made mention of the fact that the Honorable Carl Durham, a former Member of Congress, whom I recognized yesterday, and who is concerned about the drug safety problem, has agreed to serve as a special consultant to your association. You are most fortunate not only in having one of Congressman Durham's experience as a pharmacist and as a public official, but also one who has a good claim to common sense which sometimes is more beneficial than all of the theories and other things that we throw in with them.

Dr. APPLE. Mr. Chairman, we agree completely with your observation about the abilities and integrity of pharmacist, former Congressman, Carl Durham.

Mr. FOUNTAIN. Are there any other questions!

Mrs. DWYER. No questions.

Mr. FOUNTAIN. Thank you very much, Dr. Apple and Dr. Feldman. You have been very helpful to the committee.

Dr. APPLE. Thank you.

Mr. FOUNTAIN. Dr. Austin Smith, who was scheduled to appear today for the Pharmaceutical Manufacturers Association will testify at a later date.

The hearings on drug safety will be resumed after the Easter recess. The subcommittee stands in recess.

(Whereupon, at 12:05 p.m., the subcommittee recessed, subject to the call of the Chair.)

DRUG SAFETY
(Part 1)

WEDNESDAY, APRIL 8, 1964

HOUSE OF REPRESENTATIVES,

INTERGOVERNMENTAL RELATIONS SUBCOMMITTEI

OF THE COMMITTEE ON GOVERNMENT OPERATIONS,

Washington, D.O.

The subcommittee met at 10 a.m., pursuant to recess, in room 1310, Longworth Office Building, Hon. L. H. Fountain (chairman of the subcommittee) presiding.

Present: Representatives L. H. Fountain, J. Edward Roush, Florence P. Dwyer, and Bill Stinson.

Professional staff present: Dr. D. C. Goldberg and W. Donald Gray. Mr. FOUNTAIN. The subcommittee will come to order. Let the record show a quorum is present.

Today the subcommittee resumes its hearings on the subject of drug safety. As I have stated previously, the subcommittee is concerned primarily with the organization, policies, and procedures of the Food and Drug Administration for the premarketing clearance and postmarketing surveillance of new drugs.

However, while the Food and Drug Administration has the legal responsibility for deciding whether a drug is safe for marketing, there are others, including the medical and allied professions, and the manufacturers of drugs, who share responsibility for assuring their safety. At our last meeting the subcommittee heard testimony from representatives of the American Medical Association and the American Pharmaceutical Association. Today we are fortunate to have with us a number of distinguished individuals representing the Pharmaceutical Manufacturers' Association. Our witness is Dr. Austin Smith, president of the Pharmaceutical Manufacturers' Association. He is accompanied by Dr. Leonard Scheele, who for a long time was on the Washington scene and who is now senior vice president of WarnerLambert Pharmaceutical Co., and Dr. Theodore Klumpp, president of Winthrop Laboratories.

Dr. Smith, you may proceed with your statement. I would like to ask members of the subcommittee to withhold their questions insofar as possible until the statement has been completed, unless clarifying questions are necessary.

I am sorry we are pushed for time this morning. We are engaged in a debate on the floor, on a highly controversial piece of legislation, and yesterday afternoon we learned rather suddenly that we would be meeting at 11 o'clock today. We will try to continue as best we can, with some possible interruptions.

265

STATEMENT OF AUSTIN SMITH, M.D., PRESIDENT, PHARMACEUTICAL MANUFACTURERS ASSOCIATION; ACCOMPANIED BY LEONARD SCHEELE, M.D., SENIOR VICE PRESIDENT, WARNER-LAMBERT PHARMACEUTICAL CO.; AND THEODORE G. KLUMPP, M.D., PRESIDENT, WINTHROP LABORATORIES

Mr. FOUNTAIN. Dr. Smith, I wonder if it would be agreeable with you possibly to delete the first page and a good portion of the second page of your statement, dealing with the background, training, and experience of you and your colleagues, and perhaps begin at the bottom of page 2 of your statement?

Dr. SMITH. Mr. Chairman, with your permission and the permission of the members of the committee, what I would like to do is simply speak to this statement, because we hope it is rather complete and informative, and it would be a waste of your time to read it in its entirety. However, we would like to ask that it be introduced in its entirety in the record and then if I could speak rather briefly to some of the points, and perhaps amplify a few, we could then be available for your questioning for probably a longer period of time, in view of your crowded day.

Mr. FOUNTAIN. If there is no objection by members of the committee, most of whom I assume have already had a chance to read your statement, that will be satisfactory, and your statement as prepared will become a part of the record.

Dr. SMITH. Thank you, Mr. Chairman.

Just one additional point. Three individuals, in addition to the formal witnesses, are with us to aid in the answering of any questions. They represent technical areas and can better answer questions in these areas than can the three witnesses before you. These three are Dr. Karl Beyer, Dr. Karl Bambach, and Mr. Joseph Stetler. Dr. Beyer is a pharmacologist, an M.D. and Director of Merck, Sharp & Dohme Research Laboratories. Dr. Bambach is a Ph. D. in chemistry and senior vice president of the PMA; and Mr. Stetler is a lawyer, being general counsel for PMA.

In response to your invitation, Mr. Chairman, and members of the committee, we will limit our presentation to the points that were raised in your letter of March 16, although, of course, we will be glad to answer any questions if we can in any areas that you may wish to explore. As a result we are presenting a statement to you which has been divided into six parts, which are described on page 3.

Also, to save your time, rather than read these parts, I will only speak to sections of them, so permit me to move along quickly and first mention, but only briefly, the role of the pharmaceutical industry.

Skipping the pages devoted to industry contributions, because it would seem to me that these are evident, you will find in some of the material we have made available to you in the statement, in the exhibits, or in the packet material that was given to each of you-for example, in the envelope is a book, entitled "Prescription Drug Industry Fact Book". This book provides an outline of the makeup of the industry, its role in research and in the economic side of medical care, as well as other related topics.

One point which I would like to mention specifically, however, is the statement on page 4 where we refer to the effect of drugs on health, death, and economics. My reason for doing this is because as we explore this subject of safety in a little more detail, I would like to emphasize that safety is a relative thing, and the benefits have to be viewed in comparison with the side reactions or undesirable actions that sometimes arise. We choose as a specific example tranquilizers, because the story is rather clear on the status of this class of agents in the medical care picture.

Even though there have been comments from time to time about the safety of these agents, obviously as more knowledge is gained our opinions of the best possible use of such agents will have to change. Nevertheless, as an example of the need for driving ahead with what is at hand, I would just mention that since the advent of tranquilizers we have found a steady reduction in the hospital population of patients in mental institutions, in spite of the fact that there has been an increase of admissions. And this is directly related, this change, to the development and expanding use of the tranquilizers.

There is one other statement that I would also like to emphasize. While it is not necessarily directly related to safety, it nevertheless has to do with the wise use of all facets of medical care. We would like to make clear that we consider drugs to be a supplement to and not a replacement for other forms of medical care, if these others are indicated. This point we have tried to bring out on page 4 of the statement.

Incidentally, since the States that are represented on this subcommittee do have some very important pharmaceutical firms within their boundaries, I thought that perhaps you might be interested in some auxiliary information, which I was just able to complete. It, therefore, was not included in the statement. In the 8 States represented on the subcommittee, there are 23 medical schools, with which the industry works closely; close to 400 manufacturing plants; a large number of employees, more than 33,000; e total expenditure for research and development of almost $150 million; and significantly, at least to me as one who watches the scientific field rather carefully, there are about 7,500 and upward scientists in the research and development efforts of these firms.

Incidentally, also, Mr. Chairman, now and then you may find a typographical error, which we hope to be able to correct when the transcript is forwarded, but these were not corrected before the statement was mimeographed and released. In part, the statement was being typed and changed only hours before it was delivered.

On page 5 there is considerable detail of the programs of the Pharmaceutical Manufacturers' Association, as these programs are related to drug safety. Perhaps I could best summarize this past history by saying it is a long one and, as these paragraphs will indicate to you, it extends back to the World War I period. The pharmaceutical association has tried to serve as, well, sometimes a gadfly, sometimes a catalyst, sometimes just a doorway or doormat for the exchange of information between member firms and scientists of all walks of life, to develop new information and share it and then put it into practical application.

On page 6 reference, in connection with the safety and quality efforts of the drug industry, is made to a statement of principles of

37-272-64-pt. 1--18

control of quality. This statement was approved by the Pharmaceutical Manufacturers Association several years ago, and is attached as exhibit 1. I would like your permission, sir, to have it made a part of the record, because it indicates some of this gadfly catalytic activity to which I referred and which any association with scientific, as well as organizational overtones, should have in its makeup.

On page 6 there is a continuing explanation in more detail of the PMA and its work and here you will find reference to the scientific sections. A section in the PMA is essentially a medium whereby groups of individuals with mutual interests can gather to discuss their problems. There are several such sections and five of them are devoted to scientific activities. Other sections include such activities as those related to the law, public relations, and so on. By way of further explanation, and again to conserve your time, we included in the packet for each member of the committee a booklet entitled "PMA-Who, What, When, Where, Why, and How."

On page 9, having skipped most of the descriptive statements on the various sections and their work, how they participate in meetings, what the membership is, and what kind of scientific interest they de velop, there is one example to which I would like to draw your attention. Even though it is small, it does highlight the kind of detailed information which the research element in the drug industry seeks out as it attempts to study new ways, new means, for testing drugs and for assuring, if possible, not only their wise use but their safe use. On page 9 there is a section entitled "Research and Development." We have listed four titles, which are representative only of the dozens, perhaps I could say hundreds, if we considered the subcommittees, of papers that are prepared each year by and for industry scientists.

These four titles, as you will see, specifically refer to topics that today are of considerable interest not only to the drug industry, but to the Government, to physicians, and to the public at large, as well as to those who are responsible for the legislative activities in Washington and elsewhere. This committee, like other committees of the Pharmaceutical Manufacturers Association, works very closely with various groups throughout the country.

The preceding pages, plus the last paragraph on page 9, will reveal some of the examples of bodies with which the association through committees or subcommittees or other groups of individuals work very closely. For example, the National Library of Medicine, parts of the Public Health Service, the Food and Drug Administration, and so on. But in addition we work very closely and cooperatively with medical groups and with others that are in related scientific areas, as for example, pharmacologists, bacteriologists, virologists. Their sharing of information, we believe, is helpful to all. Perhaps in a way it helped make possible the undertaking of a rather unique venture, which is mentioned in some detail beginning on page 10.

I refer to the commission on drug safety. This commission was established at the time of the so-called thalidomide incident, and it was created through an enabling grant by the Pharmaceutical Manufacturers' Association. The PMA was concerned not only about the harmful possibilities of drugs and other chemicals, as they may be taken into the body, but also about the lack of information that existed.