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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the Society for Women’s Health Research

Remarks as Delivered for Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
to the
Society for Women’s Health Research
May 3, 2010


Good evening and thank you Phyllis [Greenberger] for the generous introduction and, more importantly, for your long career of service to women’s health. Your dedication to this organization and to FDA’s Office of Women’s Health has been invaluable…and millions of women have felt the direct impact of your leadership.

It’s a pleasure to be here this evening—not only because I have the opportunity to thank and commend the members of this organization for the incredible work you’ve done for the past 20 years…but also because I share with you a passion for and commitment to women’s health—and to the science that helps move it forward.

So thank you for having me. It means a lot to be here, at the largest gathering of the women’s health research community—especially as we approach a critical moment in the field.

We are beginning a month of milestones. As your organization, the Society for Women’s Health Research, is celebrating its 20th birthday, we are also entering National Women’s Health Month. Mother’s Day is coming up. And, as I’m sure you all know, so is one other anniversary in the history of women’s health.

This Sunday, May 9, marks the 50th anniversary of FDA’s approval of the Pill. It was without a doubt one of the most significant developments for women and their families in the U.S. and all over the world.

And today, its legacy is not only the 100 million women worldwide who take the Pill everyday, but also the prevalence of large-scale clinical trials involving women—something that the Pill began to inspire as early as the 60s…and something you continue to fight for today.

It’s amazing how far women’s health has managed to progress since May 9, 1960. And many of our recent advances have been thanks, in large part, to you and this important and powerful organization.

Since 1990—when you were founded to bring attention to the lack of women in medical research and clinical trials—you have fought for greater funding for women’s health research and, through the Organization for the Study of Sex Differences, for the study of sex differences that affect the prevention, diagnosis and treatment of disease.

Because of your work, doctors, political officials and many, many women have become aware of the issues that—as you’ve written before—solely, uniquely, and disproportionately affect them.

I also want to note that your Medtronic Prize for Scientific Contributions to Women's Health—which you will award for the 5th time later this evening—goes a long way in encouraging female scientists to work on issues that uniquely impact other women. Without this type of commitment, it would be impossible to cultivate a new generation of women dedicated to continuing the effort to advance women’s health.

But in addition to honoring the work you have done for 20 years, I am also here this evening to thank you. You have also been an extremely important ally—a partner, really—of the Office of Women’s Health at FDA.

Time and again, you have gone to the Hill on our behalf—first to help establish our office, then to help increase our budget. You have helped raise our visibility overall, while also advocating for specific research issues and policy initiatives.

I want to single out a few examples of this support, stretching back to the creation of FDA’s Office of Women’s health by Congressional mandate in 1994…though it’s important to note that your involvement with FDA pre-dated the creation of a formal office.

In 1994, your signature piece of legislation—the Women’s Health Office Act—helped make permanent the offices of women’s health within HHS. Our office was established that year to protect and advance the health of women through policy, science, and outreach and to advocate for the participation of women in clinical trials. Your formal support began then and hasn’t stopped since.

In 2001, you testified before the House Appropriations Subcommittee on Agriculture about a request for appropriations directed towards creating an Agency-wide database focused on women's health activities to include demographic data on clinical trials. As a result, $500,000 was allocated to our Office of Women’s Health to establish and maintain the database.

In 2006, you convened a Critical Path Initiative workshop with our Office to explore biological differences between women and men and the importance of these differences to therapeutic product safety and efficacy.

And in 2007, you successfully advocated with Congress and the media to restore our Office’s full budget and increase it by $1 million for 2008.

Of course, this is just a small sampling of the tremendous work you have done alongside—and on behalf of—our Office of Women’s Health. But it shows the depth and breadth of your contribution.

I appreciate the hard work, energy, and sacrifice that goes into each of these achievements, and I are grateful for the your help in making our work meaningful.

We look forward to another 20 years of collaboration. And another 20 years of success.

You know, they say that no one told Margaret Sanger the day the Pill was approved. She read about it in the newspaper the next day and, alone, toasted champagne in her bedroom early that morning. When she heard, she was relieved above all else—which was clear in her initial response to her son and granddaughter.

“It’s certainly about time,” she said.

Your organization has seized the legacy of Sanger and the other great women and men who have fought to improve women’s health and carried it forward into the 21st century.

And today, we celebrate every one of those successes and the many success the FDA has seen thanks to your support. It’s certainly about time.

Thank you.