We realize that S. 2368 permits the Secretary to waive the requirements of adequate scientific evidence. That may not be enough to withstand pressures not to do so in many appropriate cases. FDA should be required to waive the requirement in those cases where to enforce it would result in inefficiency and waste. Surely in such circumstances the public is best served by the change recommended. I appreciate the Subcommittee having afforded me this time. Thank you. Mr. WHITLOCK. The next association to make a statement is the National Electrical Manufacturers Association. Mr. Thomas E. Holloran will make the statement for that group. STATEMENT OF THOMAS E. HOLLORAN, EXECUTIVE VICE PRESI DENT AND DIRECTOR, MEDTRONIC, INC., AND CHAIRMAN OF THE MEDICAL ELECTRONICS SECTION OF THE NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION Mr. HOLLORAN. My name is Thomas E. Holloran, executive vice president of Medtronic, Inc. I appear here today on behalf of the Medical Electronics Section of the National Electrical Manufacturers Association, of which I am chairman. NEMA is an association of manufacturers, some of whom are involved in the design, manufacture, sale, and service of medical electronic instruments and devices. Typically, our products are external and implantable cardiac pacemakers, defibrillators, intensive care monitoring equipment, and similar diagnostic and therapeutic instrumentation. We support the Medical Device Amendments of 1973 (S. 2368), but with qualification as to some provisions. We agree with the concerns expressed in the joint statement today and are preparing a written summary of specific suggestions for submission to the subcommittee. To conserve time, I will confine my remarks to a few portions of the bill that we believe to be of paramount importance. Our industry has grown rapidly in the last 10 years by providing safe and effective products to help patients who are often gravely ill. Hundreds of thousands of people are alive today because of medical electronic health care products. We share the desire of Congress to develop a regulatory method that will protect the patient from dangerous or ineffective products. At the same time, we urge that regulation must not thwart the ability of the scientific and medical communities, with the aid of industry, to provide the essential health care products of tomorrow. If legislation is too stringent, future patients will suffer for lack of development of products that could have helped them. If the legislation is too lax, some will suffer from unsafe products. Striking a balance is complicated by the difficulty of deciding when a product is safe. Disease itself is not safe, so product safety must be constantly compared to the underlying risk that is present in the patient's diseased condition. The scientific review sections of the bill provide for referral to review panels of experts qualified to evaluate safety and effectiveness. We support the use of scientific review panels. However, there is a limited number of qualified people available to serve on such panels, and these few people are, for the most part, busily engaged in their own endeavors. We are concerned that there will be substantial difficulty in assembling scientific review panels to judge the safety and effectiveness of devices one by one and that review will be cumbersome and slow. Senator KENNEDY. Are there not already classification panels for devices in operation? Mr. HOLLORAN. That is right. I am not speaking, Senator, of the classification, but of the individual review of products as they were to be brought fourth for scientific review. Senator KENNEDY. Do they not have to review the individual in order to decide the classification? Mr. HOLLORAN. That is true, but beyond that there may have to be review of specific products to determine their individual safety efficaciousness. In the balance of my remarks, I go on to commend the portion of your bill that relates to product development protocols, because I think this is a way of ameliorating the shortage of people in looking at products one by one. We anticipate that many of the products that will be subject to scientific review will be those newest and most innovative products used for the severely ill. It is precisely these products that are most subject to change through technical innovation. Complex medical devices are evolutionary products. Their development moves ahead by fits and starts. Looking retrospectively, the device developer is constantly amazed by his own inadequacy as he improves his product. Scientific review requiring frequent resubmissions to advisory panels will not foster innovation and may severely retard the use of new technology in medical devices. We are, therefore, most encouraged by the provisions of the bill for departure from the traditional scientific review procedure through use of a product development protocol or PDP. The PDP would apply to products used by, or under the direction of, a physician, and which have low sales volume, or have a short life cycle, or are subject to frequent redesign. The product development protocol will usually be developed by the scientifically qualified review panels and may apply to whole classes of products. Such protocol will— (1) Include investigational and testing procedures; (2) Require active involvement of an institutional review committee to evaluate risk-benefit ratios: (3) Define clinical trial procedures and required findings; (5) Define the kinds of records that should be kept. Thus, a product development protocol is a comprehensive guide to the product developer defining what he must do, and what kinds of results he must obtain, prior to general marketing of his product. Senator DOMINICK. What do you mean by informed patient consent? I would not have the foggiest idea whether the device is going to be good on me or anybody else if I am a patient. Mr. HOLLORAN. I think it is incumbent upon the physician user of the product to fully advise the patient of the potential risk, not only of the disease, but of the use of the product. I think we as manufacturers have to give adequate information to physicians to help them advise their patients. Senator DOMINICK. How are we going to determine whether or not a patient is an informed patient and has given his consent? Mr. HOLLORAN. The bill points out some criteria for it, but in the final analysis it comes down to the relationship between the patient and his physician and what transpires there. Senator DOMINICK. OK. Mr. HOLLORAN. The establishment of a product development protocol is discretionary with the Secretary of HEW. If used, he has ample authority to revoke the protocol, object to the notice of completion, or totally withdrawn the exemption even after marketing has commenced if he is not satisfied that the devices covered are safe and effective. Senator DOMINICK. Let me go back to my question. Why would you not have informed doctor's consent instead of informed-patient's consent? Mr. HOLLORAN. I think that is necessary to have informed-patient consent. I think that the doctor has to be informed first certainly of the problems. Senator DOMINICK. I think we are going into legalisms which could be very difficult to handle here. That is my problem. In other words, if someone says they are going to do a mylogram on me, which they have, how do I know whether the stuff they are putting in my spinal column is worth it or not? Mr. HOLLORAN. The informed-patient consent I was speaking of here, relating to products in the development stage, and not to something that would be repetitively done like a mylogram-there should be a patient consent there too, and that is the procedure. Senator DOMINICK. One of our staff members just had a crutch that he came in on, and I do not know what happened to him, but how is he going to know whether that crutch is going to stand under his weight or not? Mr. HOLLORAN. The point I was addressing myself to is if he was requiring a new and experimental crutch, the features and risks of that crutch should be explained to him in the product development protocol stage. Senator DOMINICK. I think you are looking for a lot more intelligence in the patients than they have. Let us put it that way. Mr. HOLLORAN. I am looking for the opportunity for him to know what there is to know. Senator DOMINICK. OK. Mr. HOLLORAN. We strongly support the concept of using product development protocols. We believe they will point the way to technical advancement with safety. [The prepared statement of the National Electrical Manufacturers Association follows:] NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION (NEMA) STATEMENT FOR THE RECORD ON THE MEDICAL DEVICE AMENDMENTS OF 1973 (S. 2368) NEMA welcomes the opportunity to submit a statement for the record on Medical Device Amendments of 1973 (S. 2368). In the past NEMA has supported both consumer product safety and radiation control health and safety legislation. Today, as responsible manufacturers, we support medical device legislation. The purpose of this statement is to briefly inform you about our organization and the medical devices our members produce, and to present to you suggested amendments to S. 2368 which we believe will provide adequate health protection to the public without unduly restricting medical device use and development. NEMA is an association of electrical product manufacturers, some of whom are involved in the design, manufacture, sale and service of medical electronic instruments and devices. These electronic instruments form only a very small, but important fraction of the whole spectrum of medical devices. Typically, our products are external and implantable cardiac pacemakers, defibrillators, patient monitoring equipment, and similar diagnostic and therapeutic instrumentation. We are very proud of the impact that this advanced instrumentation has had on the care of the seriously ill in this past decade indeed, tens of thousands of lives are now being saved annually that only a few years ago were beyond help. - |