device related. The Commissioner has stressed the need for appropriate legislation that fully takes into account the differences between devices and drugs. As the Commissioner has stated, "the notion that legislation will necessarily treat devices as drugs is ill conceived and invalid," and again "we need specific laws to provide specific controls to reflect these differences."29 This philosophy is no less applicable to clinical reagents than to other devices.

To best protect the public interest, it is essential to tap the combined know-how of government, the professions and industry. Again, quoting the Commissioner, "Basic in our thinking is the concept that there must be the maximum involvement from the scientific community—the engineers, physicians, academia, hospitals, as well as the industry-in examining the present and in developing and operating an action program for the future."30 Furthermore, he has indicated that the FDA is "not inflexible" and is "anxious to listen, to talk to industry and the professions."

31

The clinical reagent industry is rapidly growing. It is not represented by any trade association which has clinical reagents as its primary concern. However, many of the leading manufacturers and suppliers of clinical reagents are members of either the Pharmaceutical Manufacturers Association or the Scientific Apparatus Manufacturers Association, or both. Accordingly, a joint ad hoc committee within these associations has been formed to deal with clinical reagents. This committee has already begun a dialogue with the FDA with regard to the emerging FDA regulatory program as announced by the Commissioner. We believe that the continuation of this dialogue is in the public interest.

We also endorse the efforts of Commissioner Edwards to achieve thoughtful balanced devices legislation. For, in his words, "sound legislation not only will assure more safe, effective and reliable medical devices, but will lead toward faster and more confident acceptance of devices by the medical community."32 We assume, of course, that the Commissioner is willing to accept the logic of including clinical reagents as part of a broad program to provide flexible regulatory controls over medical devices. Accordingly, we support the principles of device legislation enunciated in the Ad

ministration bill and believe clinical reagent systems should be included as devices.33 We also believe a limited number of other amendments should be made to improve its overall regulatory scheme.

Proposed FDA Regulatory Program

Pending the enactment of new legislation, it is necessary to consider the interim development of the FDA regulatory program. As we understand it, the FDA intends to concentrate on assuring that clinical reagents are not misbranded by their labeling. This approach, which is consistent with FDA's existing statutory authority whether clinical reagents be considered as drugs or devices, is essentially a requirement of truth in labeling. We believe that responsible members of industry will respond by cooperating with the FDA in the development of what we understand is the FDA's interim enforcement program.

In the development of any program, the following objectives should be established. First, the regulatory program should provide assurance that clinical reagents act reliably and consistently within their label claims. Second, the regulatory program should be flexible enough to recognize the limitations of current technology and should not inhibit the development of new clinical reagents and new testing procedures. Third, the regulatory program should recognize the proper role of clinical reagents in our health care system, namely, to provide information about a constituent in a specimen; the object of the regulatory program should be to assure the accuracy of the information, not to control its interpretation or decide upon its value in diagnosis, which remain the prerogatives of the physician. Fourth, the regulatory program should provide for flexibility so as

"The Administration's "Medical Device Safety Act of 1971", H. R. 12316 and S. 3028, 92d Cong., 1st Sess. (1971). In amending the Federal Food, Drug, and Cosmetic Act, the Bill would authorize the Secretary of Health, Education and Welfare to establish standards for devices relating to the composition, construction, properties, uniform identification or performance whenever such action is found necessary to reduce or eliminate unreasonable risk of illness or injury. The Administration's bill would also give the Secretary authority to require premarket scientific review of any device used in life-threatening situations where the composition, construction or properties of the

REGULATORY ASPECTS OF REAGENTS

device are such that in relation to the intended use the device presents an unreasonable hazard and there is a' no more practicable means to reduce the hazard. The Administration's bill also contains provisions which would require devices to be manufactured in accordance with current good manufacturing practices, registration of manufacturers of devices and the devices themselves, increased inspection authority, maintenance of specified records, periodic reports to FDA, notification to the Government and to customers of defects in devices, and if so required by the Secretary, remedy of the defect, replacement of the device or refund of the purchase price.

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to allow the marketing of products with differing standards and specifications in order to meet the needs of varying health care situations.

Truth in labeling is already a requirement under the misbranding provisions of the Federal Food, Drug and Cosmetic Act.34 What needs to be developed is a uniform, consistent approach to the labeling of clinical reagents. The Federal Register announcement of January 19, 1972 is a start in this direction.35 Implementation of the FDA program in the form of specific regulations is anticipated in the near future.

Regardless of the adequacy or inadequacy of the proposed FDA regulatory program under existing law, it is essential that the regulatory status of clinical reagents be clarified by Congress in its consideration of devices legislation. It is not logical to continue to operate under a definitional "grey area" in the basic legislation governing drugs and devices. As FDA General Counsel Hutt stated in a recent speech, "we have no fundamental objection whatever to undertaking some sort of redefinition of the term device to provide additional clarity. Indeed, we have agreed to sit down with interested industry groups and try to arrive at a new definition that we believe would be appropriate and that the industry and the public would believe appropriate." We believe that the reasons for specifically including clinical reagent test systems as devices cannot be seriously disputed.

§ 502 of the Federal Food, Drug, and Cosmetic Act, 21 U. S. C., § 352, provides that a drug or a device will be misbranded, inter alia, (a) if its labeling is false or misleading in any particular. [or] ... (f) unless its labeling bears (1) adequate directions for use. The directions for use should be in such detail that the intended user of the product will be instructed specifically how the clinical reagent is to be manipulated in performing the test and be informed as to the limitations of the clinical reagent in detecting and measuring the particular constituent in the specimen.

35

" The FDA, in its Notice, supra, n. 1, indicated in greater detail what labeling directions for clinical reagents should contain: “Labeling directions should include complete information on the accuracy, reproducibility, and sensitivity performance of such results as well as a complete dscription of external condiPAGE 570

[The End]

tions and patient abnormalities which may affect the accuracy of such results. The degree of false positive and false negative results and, where such exist, specific directions for verifying test results should be clearly indicated. For products which consist of or include mechanical, electronic or other instrumentation to obtain results, the labeling should provide clear instruction for calibration and routine maintenance of such products. For reagents and chemicals used for such diagnostic purposes, the labeling should contain information on proper shipping, storage, and shelf life under conditions of normal use. For products which yield qualitative information only, the labeling should explain that test results are limited to indicative rather than definitive or quantitative information."

"The Pink Sheet," April 17, 1972,

p. 21.

FOOD DRUG COSMETIC LAW JOURNAL-SEPTEMBER, 1972

Senator KENNEDY. If you have some particular recommendations to submit, we would be glad to review those.

Mr. WHITLOCK. Senator, we thank you very much for the privilege of appearing before you, and we would be happy to work with your group. Thank you, sir.

Senator KENNEDY. I want to thank you. Your group has been helpful to this committee and the staff in working out the legislation. You have also been very responsive to the questions and very hopefully we can meet some of these objections and work them out.

Mr. WHITLOCK. Thank you.

Senator KENNEDY. Our next witness this morning is Dr. Ralph B. Woolf. Dr. Woolf will represent the Planned Parenthood Federation of America, and is its national medical director. He is an active member of the American College of Obstetrics and Gynecology and a diplomat of the American Board of Obstetrics and Gynecology. I know he will be able to offer us some very useful testimony.

We had planned to have a panel with the Population Council represented, but they had to cancel late last week and will submit a written statement. However, we welcome the Planned Parenthood witnesses, and thank them for their time and effort.

We welcome you, Dr. Woolf.

STATEMENT OF DR. RALPH B. WOOLF, NATIONAL MEDICAL DIRECTOR, PLANNED PARENTHOOD FEDERATION OF AMERICA

Dr. WOOLF. Thank you very much. I am Dr. Ralph B. Woolf of New York City. I am the national medical director of Planned Parenthood Federation of America. I am a diplomate of the American Board of Obstetrics and Gynecology, and an active member of the American College of Obstetrics and Gynecology. For three decades, I was associated with a major midwestern university medical school and medical center. In addition to the duties of a professor of obstetrics and gynecology, I was for a long period the supervisor of the large, busy medical center's obstetrics and gynecology outpatient clinics.

Planned Parenthood Federation of America, comprised of over 190 State and local affiliates in 44 States, provides comprehensive family planning medical services to more than 800,000 patients each year. It is our goal to bring to American men and women the best available services for family planning and fertility-related health

care.

We also strongly endorse expanded scientific research in human reproductive biology and new family planning technology. We believe that each child should be a healthy, wanted child and that the health and well-being of all families must be secured and maintained.

Consonant with our desire to provide patients with the best possible health care, our concern includes the needs of more than 100,000 of our patients who have selected the intrauterine device as their preferred method of contraception.

When prescribed, inserted, and managed by competent physicians, experience has demonstrated that the large majority of women who select this method continue to find it acceptable and efficacious. It is of paramount importance and necessity that the health and well-being of every woman who selects this method be insured in every possible way.

Mr. Chairman, there is evidence that a proportion of infant mortality, mental retardation, congenital defects, prematurity, and brain damage are related to maternal health. The incidence of these conditions rises among older women, among first births to very young teenage women, and among women having too many closely spaced births. The use of safe and effective methods of family planning can significantly reduce infant and maternal mortality and morbidity.

The development of the oral contraceptive and the intrauterine device represent major innovations in contraceptive technology, but they are far from perfect. Both of these most effective modern methods have disadvantages and may represent hazards for some users. Many women should not use the pill because of related medical problems, such as high blood pressure, kidney disease, diabetes, and sickle cell disease. For some of these women, the IUD would be the medically preferred method of contraception.

Conversely, many women for whom IUD's are medically contraindicated are medically able to use the pill as their method of choice. While neither method contains all elements of the "perfect" contraceptive, each method has its medically indicated and individually preferred uses among the range of contraceptive methods presently available.

Obviously, it is important that consideration be given to the appropriate selection of the patient who is a candidate for utilization of the IUD. This requires expert judgment on the part of the practictioner who initially evaluates the patient. The IUD should not be used as the method of choice for all patients randomly requesting it. It is equally important that appropriate medical skill be utilized for insertion, and that medical followup be available and utilized by the patient on a periodic basis.

Regarding IUD complications and side effects, it is recognized that pain and/or fainting on insertion, heavy bleeding and cramps are common. For most women these disappear within a few months, but 10 percent must have the device removed in the first year for medical

reasons.

Expulsion may occur, particularly during the first 3 months following insertion in some women. Infrequently, uterine perforations do occur, particularly during insertion, and latent infections may be aggravated by the presence of the IUD. But sterile, innert IUD's in and of themselves, do not cause infection.

Contraindications for IUD use by our patients include evidence of known or suspected pregnancy; acute or subacute pelvic inflammatory disease; history of incapacitating dysmenorrhea or menorrhagia; known or suspected cervical or uterine malignancy; hypoplasia or distortion of the uterine cavity; cervical stenosis; or abnormal Papanicolau smears.

The occurrence of ectopic pregnancies among IUD users is less than the rate of ectopic pregnancies occurring among women not using any