form of contraception. When considering the benefits versus the risk ratio of the IUD, it should be pointed out that the risk of death from pregnancy far exceeds the risk associated with the IUD.

The opportunity to present my views concerning S. 2368 to the subcommittee is greatly appreciated. There is no question that the community-at-large needs meaningful protection from unsafe and ineffective medical devices. The sponsors of the Medical Device Amendments of 1973 are to be commended for proposing legislation which would insure that all medical devices in general, including intrauterine devices, will be safe, effective, and free of any misrepresentation. Overall, the proposed legislation is comprehensive and meritorious. It should satisfy the long overdue need for strict regulation in an increasingly important area related to the public's well-being.

To turn to specific new amendment provisions of the bill, we support the establishment of panels to review and classify all existing medical devices with respect to safety and effectiveness. We believe, however, that panel members should possess the highest possible qualifications by virtue of their expert knowledge and experience in a given field. We would therefore urge that section 511(b) reflect a strengthened nominating and membership criteria.

We strongly endorse the establishment of uniform standards in section 513 since this would create a necessary common denominator of safety and effectiveness for contraceptive device technology. In connection with this, I would like to suggest that consideration be given to an amendment to provide for appropriate new coding under the international classification of diseases.

The introduction of suitable codes will greatly facilitate the new monitoring of medical devices. In the case of contraceptive devices. the nomenclature would be standardized, and codes could be established for reporting complications associated with insertion, removal and use.

Senator KENNEDY. I think that is a very worthwhile suggestion. Dr. WOOLF. Yes, sir. We would be glad to work with you on this. Other codes could be provided to record effectiveness. Adequate standardized codes will enable the FDA, the Center for Disease Control, and other national and international government and private agencies to obtain valid pertinent data. Moreover, we also endorse the information disclosure provisions relative to standard-setting and authorization for testing to assure full compliance.

We believe that the proposed new section 514 strengthens HEW's ability to protect consumers. In addition, it recognizes the need for scientific research by providing certain exemptions for investigational use, and requires maximum protection of patient rights and welfare. I might add here that Planned Parenthood's policy states that such built-in safeguards are essential to any acceptable research involving human subjects. We therefore strongly endorse the bill's strong emphasis in this area.

We support the proposal in section 601 on records and reports with regard to clinical experience; yet, if it is the subcommittees' intent to strengthen existing law in this area, this section appears to grant exemptions which could be overly broad.

There are several other items worthy of special mention. The members of this subcommittee are aware that today there are neither

perfect methods of contraception nor methods which are fully acceptable and medically appropriate for all persons who desire to prevent unwanted pregnancies.

Research to develop more effective and safer methods of family planning is urgently needed on a continuing basis. There are 42 million American women of childbearing age who want and need better methods to plan their families. The Federal Government should provide more adequate financial support to complete the task on a crash

basis.

Unfortunately, the administration's support for research in contraceptive technology has been frozen at an inadequate level for the past 2 fiscal years. Furthermore, inflation has further eroded the true available support. With such a low level of support, there is small hope that fiscal year 1974 will be an auspicious one insofar as the discovery of more safe and effective methods of contraception.

A ray of hope seems to exist, at least for contraceptive technology, in the provisions of the proposed amendments. Under section 709, scientific research and studies are authorized which deserve full support so that necessary basic and applied research may be expanded. With adequate financial support, a long step toward the development of ideal birth planning technologies can be taken.

In conclusion, while our clinical experience has led us to have confidence in the IUD as part of the range of present methods available to us when it is inserted and managed by competent physicians, we look forward to the data that would be more fully developed and analyzed by FDA as a result of strong legislative authority. Such contributions can only help to strengthen the field of family planning in particular and health care in general.

We therefore wish to reiterate our firm support for regulatory action with respect to IUD's and believe that S. 2368 is adequate to the task. Thank you again, Mr. Chairman, for providing the forum to express our views.

Senator KENNEDY. Just before I get into some other questions, what is the support for research in contraceptive technology? What has it been for the last couple of years?

Dr. WOOLF. Approximately $28 million for NIH's basic and applied contraceptive research program. This figure includes evaluation of existing contraceptives.

Senator KENNEDY. That is what it has been for the last 2 years? Dr. WOOLF. Yes, sir. The only legislative authority for this research, the Family Planning Services and Population Research Act of 1970, authorized $30, $50, and $75 million for fiscal years 1971, 1972, and 1973, respectively, for the entire field of population sciences research. Contraceptive technology research is a component of that program. Congress wisely required that HEW submit a 5-year plan for carrying out the mandate of the law. That plan projected necessary Federal support for contraceptive development and evaluation at over $50 million in fiscal year 1973, $63 million in fiscal year 1974, and $76.5 million in fiscal year 1975.

There is no earmarking of funds specifically for contraceptive technology research or for the broader field of population sciences research in any of the appropriations bills for NIH, though emphasis

has been placed on the programs in the reports of the Senate Appropriations Committee, for which we are very appreciative. Contraceptive development research is buried within an institute of NIH which handles additionally everything from research on aging to mental retardation. One can determine only from various program documents and statements that Federal support for NIH population research has never exceeded about $39 million for the last several years. Accountability is made difficult because there is no line item for this research in the official budget of the United States. The only mention of this research in any of the administration budget documents is in the "Special Analyses," which for fiscal year 1972 contained a figure $6 or $7 million higher than any official figures given out by the program and indeed differed by $2 million from other figures within the same document. Moreover, since the figures vary at the whim of the Director of NICHD, we now understand, through correspondence with NIH, there are plans to reduce the budget of the Center for Population Research by $700,000 this fiscal year.

We have not formally evaluated them.

Senator KENNEDY. Well, informally?

Dr. WOOLF. Yes. Our national medical committee and the American Association of Planned Parenthood physicians are aware that there are unjustified claims.

Senator KENNEDY. Are you not surprised by the kind of testimony that Dr. Thomsen made last week or that evidently will issue from this preliminary report of the CDC with regards to advertising?

Dr. WOOLF. Not entirely. Some of his remarks may have been without full knowledge, but it is true that regulation of devices, and advertising related thereto, is needed.

Senator KENNEDY. I am not looking for a full endorsement of his testimony. I am interested whether you, or your organization, has reached a similar conclusion about the misleading advertisement that is in the newspapers and medical journals as it applies to IUD's. That is really what I was interested in.

Dr. WOOLF. Yes, sir. We are aware of the misstatements in certain advertisements and we rely on more scientific information for the facts.

Senator KENNEDY. Do you believe that there are classes of IUD's that have not been adequately tested or fully tested?

Dr. WOOLF. Of the IUD's available today, I think the Lippes Loop and the Dalkon Shield have been rather fully tested through clinical use, and one other IUD has probably received adequate testing.

Senator KENNEDY. What about the Saf-T-Coil, do you know whether that is included in any of those?

Dr. WOOLF. That would be the one that I included under probably, because it has not been used as extensively.

Senator KENNEDY. Do you think that the IUD's should be subject to the pre-market clearance procedures of the legislation?

Dr. WOOLF. Definitely.

Senator KENNEDY. Is it your testimony that of the two classifications, you at least would believe-satisfied with the safety requirements that have been included in the bill, and that effectiveness re

quirements and nothing else would be necessary. Would you want them to be reviewed as well with regard to safety and effectiveness? Would you want them to be studied or are you satisfied with their resulta because of past usage?

Dr. WOOLF. We believe that effectiveness is but one important aspect. Another aspect, of equal importance, is safety. A scientific review group would probably find that for several devices there is adequate data concerning effectiveness. I think, however, that continuing moni toring with regard to safety is desirable.

Senator KENNEDY. But you would not have any objection to committing the scientific panel to review those that are in operation at the present time? You do not object to that?

Dr. WOOLF. No; not at all.

Senator KENNEDY. Do you think this would be reassuring?

Dr. WOOLF. I think it certainly would be reassuring and welcomed by our organization and by the many women who are using IUD's or contemplating their use.

Senator KENNEDY. So you have no objection to the scientific panel reviewing that material?

Dr. WOOLF. None at all.

Senator KENNEDY. We have heard estimates that about 3,000 women were hospitalized the first 6 months of this year because of side effects suffered from the use of IUD's. There is the preliminary report of the CDC study. Do you have any reaction to it?

Dr. WOOLF. It seems surprisingly high. As you know, the survey is still underway and it is difficult to comment on these preliminary returns which are unrefined data really. I would prefer to see the entire completed report before commenting substantively, and I am anxious to see the data on it.

Senator KENNEDY. Senator Dominick.

Senator DOMINICK. Doctor, some of the previous witnesses have indicated that they were not sure that there were enough component people to man these panels. On page 4 you endorse the panels and asked for strengthening of the nominating and membership criteria.

What do you mean by strengthening the nominating and membership criteria?

Dr. WOOLF. That may have some basis in fact, that there are a number of outstanding individuals in the field of contraceptive technology and obstetrics and gynecology.

Senator DOMINICK. You think there are an adequate number then? Dr. WOOLF. Yes, sir.

Senator DOMINICK. In what way should we strengthen the nominating and membership criteria?

Dr. WOOLF. We mean to suggest that people with considerable expertise serve on the panels.

Senator DOMINICK. Who is going to judge who is an expert?

Dr. WOOLF. I think that the scientific community and other bodies, such as the American College of Obstetrics and Gynecology could assist in a general way.

Senator DOMINICK. You therefore think that the nominating procedure should come through the established organizations in the particular specialty, is that correct?

Dr. WOOLF. I would feel that they could assist in identifying who is doing outstanding work, for example, yes, sir.

Senator DOMINICK. That is a little bit like saying that the American Bar Association is going to pass on all the judges, and I do not agree with that either. I have a little hangup on that.

In any event, what you would like to do is to make sure that the socalled leaders in the field are the ones who are on the panel?

Dr. WOOLF. We are suggesting that panel members possess "outstanding skills," and do not intend to imply that they must be the leaders in their respective fields.

Senator DOMINICK. Thank you.

Senator KENNEDY. Thank you very much, doctor.

[The prepared statement of Dr. Woolf with an editorial accompanying it follows:]