Remarks
by
David A. Kessler, M.D.
Commissioner of Food and Drugs

Capitol Hill Briefing on New Frontier
in Breast Cancer Imaging
and Early Detection

Washington, D.C.
October 11, 1994

NOTE: THIS TEXT IS THE BASIS OF COMMISSIONER KESSLER'S ORAL REMARKS. IT SHOULD BE USED WITH THE UNDERSTANDING THAT SOME MATERIAL MAY HAVE BEEN ADDED OR OMITTED DURING THE PRESENTATION

Good morning.

We are here today to take advantage of an important public health opportunity. Our task is to encourage the development of new technologies for breast cancer imaging and early detection.

The need for improved technologies in this area is urgent, and I wish to thank Dr. Blumenthal for bringing together a group of people who can advance that goal. I can assure you of FDA's - - and my own -- wholehearted desire to work with you to make this endeavor a success.

For us at FDA breast cancer is one our nation's highest priority issues. The reasons are obvious. There is hardly a family in this country that has not been hurt or devastated by breast cancer. And FDA is part of the defense system that combats this menace.

It is FDA's mandate to ensure that screening, diagnostic and treatment modalities developed for breast cancer are not only safe, but also effective. We take that responsibility very seriously, and we're more than ready to join any effort to improve early diagnosis of breast cancer for women of all age groups.

Currently, one of the most important tools for the detection of breast cancer in its earliest, most treatable stages, is mammography. The U.S. Public Health Service has sent out a strong message encouraging women at high risk for developing breast cancer to have screening mammograms.

And it is FDA's responsibility to these women to ensure that mammography is performed under optimal conditions and that mammograms are reliable and of high quality. The issue of quality in detecting breast cancer through mammography was recognized by Congress as a major public health priority.

In 1992, under the leadership of Senator Barbara Mikulski, Senator Edward Kennedy, and Representatives John Dingell, Marilyn Lloyd, and Olympia Snowe, Congress passed the Mammography Quality Standards Act.

Recognizing the longstanding effort of FDA in the area of mammography quality assurance, Secretary Shalala in June 1993 delegated to FDA the responsibility for administering the new law.

It is my pleasure to tell you that we have made important progress. October 1 -- just a few days ago -- was the deadline for all mammography units in the United States to receive initial federal certification.

I am pleased to report that more than 10,000 of the 11,000- plus mammography facilities in the U.S. have taken steps to meet the certification requirement.

The tasks associated with implementing the Act under such a short deadline have been enormous, and FDA is proud of what has been achieved so far.

Much of the credit goes to Dr. Florence Houn and her staff who have assumed responsibility for all aspects of the Act's implementation. Dr. Houn was put in charge of the new Division of Mammography Quality and Radiation Programs in our Center for Devices and Radiological Health in December, 1993.

She has been instrumental in enlisting leading mammography experts in the newly created National Mammography Quality Assurance Advisory Committee, which had been mandated under the new legislation.

Many of these experts are here with us today, and so is Dr. Houn. I would like to ask her to please stand up and be introduced to this audience.

FDA remains active in conducting research into quality standards for new technologies and products already in use. Quality control for mammographic processing, called the "STEP procedure," was developed by FDA.

Presently FDA is participating with the American Association of Physicists in Medicine on a committee to develop quality standards for mammographic stereotactic biopsy equipment.

In addition, the National Mammography Quality Assurance Advisory Committee is advising FDA on new technologies and quality standards for conventional mammography.

FDA, as an agency within the U.S. Public Health Service, is joining forces with the National Cancer Institute, the Department of Defense and other Federal agencies to rapidly bring new cancer imaging technologies to the American public.

We are developing standards and product development guidances for rapid approval of new products. We encourage industry, professional societies, academia, and our sister federal agencies and departments to work with us to bring to market new products for breast cancer detection and diagnosis, and to do it as quickly as possible.

I also invite all of you to stop at the FDA exhibit. You'll meet there our staff members who can discuss with you new technologies involving drugs, biologics or medical devices.

More than 1.5 million U.S. women will develop breast cancer by the end of the decade. In light of that chilling statistic, FDA's role is clear.

We have to do all we can to encourage rapid development and commercialization of useful techniques for breast cancer detection. Our new Office of Women's Health -- which is located within my Office -- as well as all other components of the Agency are ready and eager to do their part.

They will continue to work closely with Dr. Susan Blumenthal, Congress, with our colleagues in other Federal agencies, with industry, consumer groups, and the clinical and scientific communities.

American women expect from us a maximum effort to bring to them improved methods of breast cancer imaging and early detection. I can assure them that FDA will not disappoint them.

####