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"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some of the material may have been added or deleted during actual delivery."

Remarks by:
Jane E. Henney, M.D.
Commissioner of Food and Drugs



APRIL 29, 1999


Good Afternoon. It is a pleasure to be here today. We are rapidly approaching the turn of the century, and the beginning of a new millennium. This past century has witnessed a rapid evolution (finally) of the role of women in our society.

Over the past one hundred years, we have seen women achieve the right to vote, to receive greater access to education, jobs, and opportunities, and to represent our society in elected office, as heads of corporations, and leaders in academia. From the boardroom to the Supreme Court, women are increasingly becoming our leaders and inspirations. Now it is critical that we ensure that all women are empowered through an increase in knowledge about and involvement in health care and health research.

As an oncologist and a woman, I hope to bring a new perspective to what I consider to be one of the most important public health regulatory agencies. Being the first female FDA Commissioner is an honor, and to know that I won't be the last is satisfying.

As new technology emerges, we need to ensure that women from all communities--including African Americans, Native Americans, Asians, and Latinos--are able to lead stronger, happier, and healthier lives through an increased focus on health care issues of importance to women.

We are finally beginning to realize that diseases may present and progress differently in women, and drugs may have different biological effects in different populations. There is increased awareness about potential gender differences and the need to consider these differences in the design and analysis of studies. For example, there is an increased recognition that certain factors may affect testing outcomes, the effect of hormones,to cite one fairly obvious example.

We also have been faced with knowledge gaps that we are trying to close with the aid of additional research: the need for information about normal development of healthy women, not just a focus on disease; a focus on disease conditions that are more prevalent in women, including Alzheimer's disease, osteoporosis, and lupus; an analysis of the chronic problems that women face more often than men; and a look at why, although they live longer, women are shown to have more disabilities than men.

Traditionally, women's health care was equated with healthcare involving the reproductive systems, particularly in terms of childbearing. Researchers regarded men as the norm and women as a variation of the male model.

As recently as 1977, FDA's guidelines on drug testing recommended that women of childbearing potential not be used as research subjects in the earliest phases of drug trials. Happily, there has been an important shift in recent years toward the inclusion of more women in research studies, including minority women.

This change can be partially attributed to pressure from women, individually and collectively, insisting that they be permitted to make their own informed choices about participation in such trials. It seems ironic that a society that has women making decisions about our nation's laws, policy, military strategy, educational systems, and other fundamental areas has just relatively recently acknowledged that women can make their own informed choices about participation in clinical studies.

FDA's 1993 gender guideline lifted the restriction on women's participation in clinical trials and stressed the importance of identifying clinically meaningful sex differences in a drug's effectiveness. Fetal protection was and is still an important concern, but the new guidelines suggest ways of designing studies to reduce the risk of fetal exposure. This change in thinking, and now in Agency policy, allows much greater understanding of drugs that are used in women.

Since the 1993 gender guideline was put in place, FDA has taken additional steps to clarify and strengthen its position on women in clinical trials. In 1997, we published a proposed rule that would permit FDA to put any proposed or ongoing trial for a life-threatening illness on hold if women with reproductive potential are excluded from any phase of the investigation.

In February 1998, FDA's regulations regarding new drug applications were amended to require sponsors to report the number of subjects enrolled in clinical studies by gender, age, and race, and to break down their safety and effectiveness data into the same subgroups. Investigational new drug applications must now include demographic data in annual reports. These new requirements will help to increase awareness about the importance of including women and minorities in clinical trials.

At the same time, section 115 of the Food and Drug Administration Modernization Act of 1997 requires that the Secretary shall, in consultation with the Director of NIH and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials.

We recognize that there are many societal and socioeconomic factors that affect the composition of study populations and there are also clear examples of products where the efficacy or safety profiles differ by racial subgroups. Although the FDA working group to implement FDAMA section 115 did not find evidence of barriers to the enrollment of minorities in clinical trials that are regulatory in nature or could be addressed by regulatory guidance, we will continue to implement procedures that will enhance our ability to gather, search, and evaluate demographic data. These processes will make it possible to determine trends or indicate deficiencies, and decide whether additional guidance should be developed in the future.

In another provision of the Modernization Act, Congress mandated that FDA and NIH develop a publicly available a database of information on clinical trials for serious and life threatening diseases. The National Library of Medicine is responsible for creating this database and we at FDA are working closely with them on this project. We anticipate that the NIH trials will be available by the end of 1999 with drug company trials to be added in the year 2000.

This initiative builds on the success of similar programs in the cancer and AIDS areas, with an expansion to other diseases. Through this information system, patients will have access to information about clinical trials being conducted throughout the United States. The law requires that the information be available in language that is readily understood by the public. Nonetheless, one of the greatest challenges will be to ensure that information about this program is available to all women, in all communities and cultures, and from all socioeconomic backgrounds.

While we are clearly making progress regarding inclusion of women in clinical trials, we must continue to confront another challenging issue--the fear or distrust of the medical research community. The history of human experimentation done without informed consent and with little regard for research subjects shows us that there are some hurdles to overcome in this area. Tuskegee conjures up abuse, suffering, death and exploitation for members of the African American community.

We need to focus on ensuring that there is adequate informed consent, based on a real understanding by the trial participants. To do this we will need to do outreach to minority women, in particular, for as we all know, women hold the vital role of being opinion leaders in their families and communities. For our part as a health agency, we must help to ensure that the educational materials we provide reflect the language and culture of our many audiences.

In this regard, the FDA has been working on several initiatives that specifically relate to women in minority communities. One such program is "Minority Women's Health Empowerment." This program emphasizes issues of importance in the area of health promotion and disease prevention and is undertaken in seminars held in community centers, local churches, and schools. These workshops include information regarding diabetes, hypertension, heart disease, breast and cervical cancer, and AIDS in an effort to increase minority women's understanding of health issues and influence health behavior that results in positive outcomes.

The FDA Office of Women's Health has been working with the Howard University Cancer Center on its "Breast Cancer Awareness Program," which strives to get out the message that early detection of breast cancer saves lives. The Office of Women's Health is also involved in the "Take Time to Care Program." Important partnerships with Spelman College and other universities assist in taking the message about using medications wisely to minority communities.

The FDA Office of Special Health Issues has sponsored meetings on "Deadly Diseases and People of Color." These meetings are a part of the Agency's longstanding commitment to encouraging the study of therapeutics in diseases that have a disparate impact on people of color. FDA is strongly committed to seeing that the safety and effectiveness of medical products are analyzed for the therapies' intended populations.

One last area that I would like to mention is FDA's Diversity Databank, which was founded by Dr. Celia Maxwell during her time at the Agency. I know that FDA's loss of Dr. Maxwell was Howard University's gain. The creation of this databank helps to facilitate the hiring of underrepresented minorities, particularly scientists, and to identify qualified minority scientists for FDA advisory committees.

In addition to our efforts in recruiting for the Agency, we also need to enlist the help of clinicians, nurses, social workers, and others working in communities where they can help women make more informed decisions about their health care. It is critical that we work together to improve the future of healthcare for women in this country, starting with our relationships with patients. At FDA, we have many different avenues through which we provide information to health care professionals, consumers, and the media.

As we look to the future, I would like to leave you today with a quote from one of the great women of the twentieth century. In the words of Eleanor Roosevelt, "You have to accept whatever comes, and the only important thing is that you meet it with the best you have to give." I look forward to the future of FDA, working together with health care professionals such as yourselves as we meet the challenges of tomorrow.