Senator KENNEDY. Very fine. Obviously we want to make sure that the goal is to be sure that all our surgeons are adequately skilled and that they are going to use the most effective and safest devices possible. Mr. WHITLOCK. Our next association, Senator, is the Pharmaceutical Manufacturers Association, represented by Mr. Rodney Munsey. STATEMENT OF RODNEY R. MUNSEY, ASSOCIATE GENERAL COUNSEL, PHARMACEUTICAL MANUFACTURERS ASSOCIATION Mr. MUNSEY. Thank you. I am associate general counsel of the PMA and also serve as staff liaison to a newly created PMA section on medical devices and diagnostic products. Although the association has been traditionally more concerned with prescription and ethically promoted drugs (our firms manufacture and distribute about 95 percent of such products made and sold in the United States), the member companies of PMA have over the years become more and more involved in the production and distribution of the products which would be subject to S. 2368. We are pleased to join with the other associations represented here today in general support of this measure which as you know is similar in many respects to S. 1446. We believe that the amendments which have been included in S. 2368 are not only acceptable but will serve to make the measure a more effective tool in regulating the devices industry. The inclusion of a definition of devices and diagnostic products, and a product development protocol mechanism are but two of the many examples that could be cited. We are also pleased to be one of the associations supporting the amendments to S. 2368 proposed here today by Mr. Whitlock. In our view, the acceptance of these amendments is most important in the interest of devising an effective and workable bill. In addition to the proposals included in Mr. Whitlock's statement, most of the associations represented here agree on some additional minor changes. PMA and the other associations have filed, or will file separately, more extensive written comments containing these and other suggestions. I will not, therefore, take time to discuss them now. Rather, I would like to stress the importance to us of the suggested change in the definition of "adequate scientific evidence" in the premarketing clearance provisions in the bill. This change would require the Secretary to accept clinical experience and other scientific data when the experts believed such evidence to be sufficient. It should be remembered that we are not just talking about devices developed after passage of a devices bill. Under S. 2368, the scientific review (or premarketing clearance) provisions could be made applicable to many older, well-established devices, considered by experts to be safe and effective. To require manufacturers of such devices to undergo expensive and time-consuming "sufficient well-controlled investigations" for such products; to require that the services of clinical investigators (who are admittedly in short supply) be consumed in conducting such studies; and to require FDA reviewers and outside advisory panels to review such studies-seems to us to be wasteful and unnecessary. It is our firm conviction that where recognized experts conclude that clinical experience, tests or other scientific evidence show a device to be effective, that should be sufficient. Senator KENNEDY. Is it not really a question of what kind of evidence we are going to use? We have heard that some doctors are willing to swear by some of these devices that we saw last week. I would think you would have to label them quack devices. Yet doctors would most often be thought of as possessing expert knowledge. Mr. MUNSEY. By "experts" here, we are talking about expert panels. The bill uses outside panels liberally throughout, which we think is an excellent idea. Our only point is that these experts should be able to draw upon their total experience and not be limited just to what constitutes a sufficient well-controlled investigation. Senator KENNEDY. What is wrong with well-controlled investigation? Mr. MUNSEY. I could never find anything wrong with well-controlled investigation. However, if you have limited resources, and it is clear it is not needed, it does not seem to us to be wise to use those resources. One thing we should keep in mind is that we are talking about a great many older devices that have been in the market a great number of years, and once you have had a wealth of experience, you are in a different situation than with a new device, where you want controls, clinical guidelines, and testing. Senator KENNEDY. OK. Mr. MUNSEY. Recently, much concern has been expressed by the scientific community about the decline in the introduction of new prescription drugs in this country. Our written comments will expand on this point. Certainly, one of the contributing factors, however, has been the excessive statutory requirements in the 1962 drug amendments for tests for well-established drugs. I appreciate the subcommittee having afforded me this time. Senator KENNEDY. What can the organization do to be sure that the advertising of its products is not exaggerated. We saw examples of such exaggeration referred to in Dr. Thomsen's testimony last Friday. What can your group do to stop that? Mr. MUNSEY. Speaking for PMA, we have in effect a code governing the advertisements of prescription drugs. Now that we are involved in devices, we will give serious consideration to amending that code to include devices. Senator KENNEDY. Do you have it now? Mr. MUNSEY. We have a code in effect now for prescription drugs. Senator KENNEDY. What about devices? Mr. MUNSEY. We have just recently established our new section, so I believe I can say we will be considering amending that code to include it. Senator KENNEDY. But it is not in effect now? Mr. MUNSEY. No sir. Senator KENNEDY. I am most anxious to know what the industry is doing or is prepared to do about these exaggerated claims. Mr. MUNSEY. I think, Senator, the response from the device manufacturers there is very little of that--but it seems to be a combination of industry codes and the suggestion in your bill transferring advertising to FDA, which I think has more resources and time, and I think the two combined should result in Senator KENNEDY. This is not only Dr. Thomsen's claim. The CDC is doing that study as well. There is a preliminary report on it, which I think will probably support Dr. Thomsen's observations and which is obviously troublesome. Senator Nelson was unable to be with us, but I know he would want to ask me whether you have any comments on his bill. Mr. MUNSEY. I would be glad to supplement later on in my remarks. I can give you a few observations at this point. I believe preclearance criteria in Senator Nelson's bill errs in two respects. One of the criteria is allowing preclearance any time there is a probable cause found by the Secretary that there is a question on effectiveness. This would put anything in the ball game that he wanted to put in. In the area of standards there is absolutely no criteria in that bill as to when the Secretary can require standards. Second, the type of standards that can be required in his bill, unlike your bill-you could go across the board-whereas your bill does talk in terms of safety and effectiveness and other appropriate aspects of it. The custom device exemption, I think, in Senator Nelson's bill is narrow, and as a matter of fact we are suggesting some changes in your bill on this as well. I can put some other remarks in the record. Senator KENNEDY. Whatever additional comments you want to make would be appreciated. Senator DOMINICK. If I could just ask a couple of questions here first of Mr. Munsey. Do I understand, I want to make sure of this, that you think that diagnostic products should not be regulated in the same manner as drugs? Mr. MUNSEY. Very much so, sir, but I think another gentleman on this panel would be far more qualified to give a complete answer on diagnostics. Senator DOMINICK. Let me ask you one more question. Is your statement on page 2, which asked that the Secretary accept clinical experience, directed only to those devices which are presently on the market? Mr. MUNSEY. In substance, Senator, because there could be no such experience for products as are newly developing. So the thrust of this, the main effect of this suggestion would be on the older, well-established devices. Senator KENNEDY. I want to clear that up, because it is exactly what bothers me. Mr. MUNSEY. I think the investigation of new devices will handle this problem. When I am talking about clinical experience, we are not talking about random letters, letters going in saying that this is fine. We are talking about clinical experience that has been so extensive and widespread and so documented that the expert panels would consider that chosen device to be effective. [The prepared statement of Mr. Munsey follows:] Statement of Rodney R. Munsey, Associate General Counsel Pharmaceutical Manufacturers Assocsation Before Senate Subcommittee on Health September 17, 1973 Mr. Chairman and Members of the Committee: I am Rodney R. Munsey, Associate General Counsel of the PMA; the Pharmaceutical Manufacturers Association. I also serve as staff liaison to a newly created PMA Section on Medical Devices and Diagnostic Products. Although the Association is traditionally more concerned with prescription and ethically promoted drugs (our firms manufacture and distribute about 95 percent of such products made and sold in the United States), the member companies of PMA have over the years become more and more involved in the production and distribution of the products which would be subject to S. 2368. We are pleased to join with the other associations represented here today In general support of this measure which as you know is similar in many respects to S. 1446. We believe that the amendments which have been included in S. 2368 are not only acceptable but will serve to make the measure a more effective tool in regulating the devices industry. The inclusion of a definition of devices and diagnostic products, and a product development protocol mechanism are but two of the many examples that could be cited. We are also pleased to be one of the associations supporting the amendments to S. 2368 proposed here today by Mr. Whitlock. In our view, the acceptance of these amendments is most important in the interest of devising an effective and workable bill. In addition to the proposals included in Mr. Whitlock's statement, most of the associations represented here agree on some additional minor changes. PMA and the other associations have filed, or will file separately, -2 more extensive written comments containing these and other suggestions. I will therefore, take time to discuss them now. Rather, I would like to stress the Importance to us of the suggested change the definition of "adequate scientific evidence" in the pre-marketing clearance p visions in the bill. This change would require the Secretary to accept clinical experience and other scientific data when the experts believed such evidence to b sufficient. It should be remembered that we are not just talking about devices developed after passage of a devices bill. Under S. 2368, the scientific review (or pre-marketing clearance) provisions could be made applicable to many older, well-established devices, considered by experts to be safe and effective. To require manufacturers of such devices to undergo expensive and time-consuming "sufficient well-controlled investigations" for such products; to require that the services of clinical investigators (who are admittedly in short supply) be consumed in conducting such studies; and to require FDA reviewers and outside advisory panels to review such studies--seems to us to be wasteful and unnecessary. It is our firm conviction that where recognized experts conclude that clinical experience, tests or other scientific evidence show a device to be effective, that should be sufficient. Our amendment could not, of course, apply to newly developed devices because they could not have been made subject to clinical experience or other scrutiny. Recently, much concern has been expressed by the scientific community about the decline in the introduction of new prescription drugs in this country. Our written comments will expand on this point. Certainly, one of the contributing factors, however, has been the excessive statutory requirements in the 1962 Drug Amendments for tests for well-established drugs. |