This proposal of the association is intended to provide an avenue which could be used by drug manufacturers and others to obtain review, when necessary, by a group of impartial, non-Government experts of a decision by FDA scientists. We are not aware of any steps being taken along these lines by FDA. In our opinion the review group should be administered in such a way that experts designated by an interested company could participate in at least some of the deliberations of the body and be given ample opportunity to provide facts for consideration by the group. In this connection the Greater Philadelphia Committee for Medical-Pharmaceutical Sciences adopted a resolution on May 14, 1964, endorsing a similar recommendation, which had been made by Dr. I. S. Ravdin, vice president for medical affairs, University of Pennsylvania, in a letter to AMA News, published April 27, 1964. The letter contains this statement: "A number of us are of the opinion that what we need is an independent, impartial reviewing council, made up of highly qualified practitioners and scientists, which could evaluate the facts when questions arise concerning the value of a specific drug. Such a council would, of course, need to be independent so that it would not merely echo the viewpoint of the FDA. Manufacturers should not appeal to the council without good cause, and, for that reason, the entering of an appeal should have some difficulty attached to it. The decisions of such a council should not be legally binding on the FDA, but should be advisory." "5. 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 record and reporting regulation which FDA promulgated on May 28, 1964, describes in detail the reports which the agency requests from manufacturers on the safety and efficacy of drugs. This regulation, in preliminary form, was the subject of discussion between representatives of the pharmaceutical industry and FDA. It was also published in proposed form in the Federal Register and was promulgated after FDA gave consideration to formal comments submitted by interested parties. However, the final regulation contains several provisions which, in our opinion, will require additional consideration and improvement. A joint Government-Industry Board, as suggested in the recommendation quoted above, could be of service in situations of this type, in preparing such regulations, and in recommending future changes. Dr. GOLDBERG. In the material that you prepared for the previous record on statistics concerning sources of new drugs, you show the percentage of drugs from the year 1941 which have originated in the Government, in State agencies, in research institutions, and in the pharmaceutical industry. Then you go on to say there is no indication of a product resulting from a joint Federal Government-industry research effort. How do you classify a product when the chemical compound is synthesized by industry, but a practical use or application for the drug is discovered by a Government agency! Dr. SMITH. Pharmaceutical industry contribution-the discovery. Dr. GOLDBERG. I see how you make the classification. I am thinking now about the meaningfulness of that classification in terms of your statement that there has been no product resulting from joint Federal Government-industry research efforts. To refer specifically to a product, we had testimony from NIH that Merck's Aldomet was a synthesized chemical compound which had been sitting on Merck's shelf for 5 years, I believe, before NIH scientists found a use for that drug. Would that not be a cooperative or collaborative venture! Dr. BEYER. I was listening to this definition and thinking about that specific compound. Actually that agent and the thesis back of the projected mode of action of it was synthesized a number of years ago and was checked out in the laboratory and was demonstrated to inhibit the decarboxylation of the precursors to norepinephrine and epinephrine, and was checked elsewhere by an investigator prominent in the field, since dead, and in the design of his specific study he found nothing. I say all this not to minimize in any sense the efforts of Dr. Sjoerdsma and Dr. Udenfriend at National Institutes of Health. Indeed, they became interested in the fact that this was available and wanted to check out their own ideas with regard to the metabolism of these compounds and, really, I think at the time they did this it was more or less to prove that it didn't work as an antihypertensive agent. Dr. GOLDBERG. They testified that Merck had found no use for the drug, that it was simply sitting on the shelf, and that they discovered the practical use for the drug. Was that incorrect testimony! Dr. BEYER. It is clear that they found the antihypertensive action of the compound. This is clear, and, if this will suffice for your purpose, I would just as soon leave it at that. Dr. GOLDBERG. My question was, Would this not be better classified as a cooperative effort, rather than a drug which is attributed solely to industry discovery! Dr. BEYER. Personally we would look to this as a collaborative effort. We look to NIH for collaborative efforts where our interests and theirs coincide. And I would in no sense minimize this. There are many very intelligent dedicated clinical and preclinical investigators in the National Institutes of Health. Dr. SMITH. Dr. Goldberg, your point would be covered on pages 3 and 4 where we refer to joint medical research problems. What we are talking about on page 2 is different. The problem that Dr. Beyer was talking about would be included on page 3 and certainly this is a cooperative effort of one type or another between Government and industry and it goes on all of the time. But the discovery of the product, which was the question originally raised back in April, is responded to by our statement here on page 2. Dr. GOLDBERG. I was interested only in your classification system. Let me ask one further question: How did you classify "5 Fluorouracil"! Dr. SMITH. Dr. Beyer! Dr. BEYER. It isn't clear that anybody has classified that, is it! Dr. SMITH. That last one is a matter of considerable dispute at the moment, I believe. Dr. GOLDBERG. Wouldn't that be included in your list of basic new drugs? Dr. BAMBACH. Maybe so. Mr. FOUNTAIN. Maybe we will save that answer by the bell, since we have a quorum call. The subcommittee will stand adjourned until further call of the Chair. I want to thank you gentlemen for taking your time to come and give us the benefit of your thinking and to answer our questions. (Thereupon, at 12:25 p.m., the subcommittee adjourned, subject to the call of the Chair.) O 37-272 DRUG SAFETY (Part 2) HEARINGS BEFORE A SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS HOUSE OF REPRESENTATIVES EIGHTY-EIGHTH CONGRESS SECOND SESSION APRIL 22, 23, 28, 29; MAY 6; JUNE 17 AND 18, 1964 Printed for the use of the Committee on Government Operations U.S. GOVERNMENT PRINTING OFFICE COMMITTEE ON GOVERNMENT OPERATIONS WILLIAM L. DAWSON, Illinois, Chairman CHET HOLIFIELD, California L. H. FOUNTAIN, North Carolina JOHN S. MONAGAN, Connecticut TORBERT H. MACDONALD, Massachusetts WILLIAM S. MOORHEAD, Pennsylvania B. WALTER RIEHLMAN, New York ROBERT P. GRIFFIN, Michigan GEORGE M. WALLHAUSER, New Jersey CHRISTINE RAY DAVIS, Staff Director INTERGOVERNMENTAL RELATIONS SUBCOMMITTER L. II. FOUNTAIN, North Carolina, Chairman FLORENCE P. DWYER, New Jersey JOHN A. BLATNIK, Minnesota TORBERT H. MACDONALD, Massachusetts BILL STINSON, Washington J. EDWARD ROUSH, Indiana JOHN E. MOSS, California DELPHIS C. GOLDBERG, Professional Staff Member JAMES R. NAUGHTON, Counsel W. DONALD GRAY, Senior Investigator |