20 Years of Improving Women’s Health: 1994 – 2014

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.As we celebrate the 20th anniversary of the FDA’s Office of Women’s Health, I would like to highlight some of the work we’ve done to help improve women’s health, both looking across FDA and within the office. Whether it is approving new treatments for chronic conditions like heart disease, conducting research or helping to protect pregnant women from foodborne illnesses, the work we do at FDA makes a difference throughout a woman’s life.

Consider our product approvals. In 1996, for example, our agency approved a product for use in Pap smears that revolutionized the detection of cervical cancer; ten years later we approved the first vaccine for the prevention of this cancer. We have also approved advances in breast imaging, including 3D breast tomosynthesis and automated screening ultrasound.

We have encouraged innovation in lupus treatment and approved the first new lupus drug in 50 years. And we approved the latest generation of cardiac synchronization therapy devices which our own FDA scientists have shown particularly benefit women with heart failure.

FDA has also supported research to help us better understand how medical products affect women. Since 1994, the Office of Women’s Health research program has provided $30 million to support over 300 research projects, workshops, and trainings on a wide range of topics including cancer, HIV and osteoporosis. More than 25 percent of these research dollars have been directed at cardiovascular disease, the number one killer of women, with studies examining such issues as QT interval prolongation (a disorder of the heart’s electrical activity), how breast cancer drugs can affect the heart, and sex differences in various cardiac interventional therapies. FDA’s medical product centers have also sponsored women’s health research and initiatives such as the Health of Women Program that promote a better understanding of sex differences.

The results have been impressive: OWH’s research alone has been published in over 290 articles in peer-reviewed journals and has made impact on the regulatory decision-making process, including guidance documents, label changes, and standards development. Indeed, FDA’s guidance to industry is an important way that the agency has been helping to address important issues in women’s health.

Over the years, FDA guidance has encouraged greater inclusion of women in clinical trials and the evaluation of sex differences. Our own analysis last year found that women make up about half of the representation in these studies, but the numbers are lower for medical devices. So we have more to do and recently issued guidance to medical device developers to address this concern.

We have also made great strides in our communication and outreach to women during the past two decades. OWH’s Take Time to Care Program has built partnerships with other government agencies, retailers, and national organizations that provide millions of women with FDA safety information. Over the years, we have launched other educational initiatives like the Food Safety for Moms-to-Be and expanded the women’s health resources available via our “For Women” website and social media to make sure that women have tools to help them make informed decisions about the use of FDA-regulated products.

I am pleased at how much we have done to promote and protect women’s health since 1994. At the center of much of this change has been the consistent, driving force of the Office of Women’s Health and its determined leader, Marsha Henderson. I encourage you to check out OWH’s 20th Anniversary brochure to learn more about the progress that has been made. And I hope that you will collaborate with us on the work that still needs to be done.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

A Valentine for Your Heart

By: Margaret Hamburg, M.D.

Valentine’s Day, when we celebrate matters of the heart, is the perfect reminder that February is American Heart Month.  There’s no better gift for those you love, or for yourself, than to help ensure a healthy heart.

Heart disease is the leading cause of death in the United States.  One in every three deaths in our country is from heart disease and stroke.  That’s equal to 2,200 deaths each day, every day, or more than 800,000 per year.  But more than abstract statistics, every victim is a parent or child, spouse or sibling, grandparent or friend.  There’s not a single family, not a single individual, who hasn’t been touched by this devastating epidemic.

Margaret Hamburg, M.D.Cardiovascular disease is also very expensive.  Together, heart disease and stroke hospitalizations in 2010 cost the nation more than $444 billion in health care expenses and lost productivity, and they are among the leading causes of disability.  One out of every six health care dollars is spent on cardiovascular disease treatment, and cardiovascular disease accounts for the greatest disparity in life expectancy across our racially and ethnically diverse population.

Too often, when we think of heart disease, we think that it only affects men.  Nothing could be further from the truth.  Nearly 43 million women, one-third of all women in America, are living with or are at risk for heart disease.  More women die from heart disease than from anything else, more than from all forms of cancer combined, and it’s largely preventable.

The FDA Office of Women’s Health (OWH) maintains a web page which provides links and resources related to heart health.  The website features the OWH heart disease in women fact sheet and publications on hypertension, cholesterol, smoking cessations, and other ways to promote a healthy heart.

As a physician, I know that hereditary issues play a role in heart disease.  But, the majority of risk factors are controllable or treatable, regardless of your age or physical ability.  Make healthy eating choices.  Don’t smoke.  Reduce sodium and transfats in your diet.  Regularly check your blood pressure and cholesterol levels.  Maintain a healthy weight.  Manage stress.  And, get active.  All of these things will help you enjoy a healthy heart and lifestyle.  Use this American Heart Month to educate yourself about heart disease, its risk factors, and ways to beat it.

One way the Department of Health and Human Services (HHS) is helping Americans achieve healthier hearts and lives is through the “Million Hearts” initiative.  It’s a new public-private partnership launched in September of 2011 that’s trying to prevent one million heart attacks and strokes by 2017.  The “Million Hearts” initiative will focus, coordinate, and enhance cardiovascular disease prevention activities across the public and private sectors through a wide range of activities targeted at improving clinical care and empowering Americans to make healthy choices.

Within HHS, the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services are helping us lead the “Million Hearts” initiative, working alongside many other federal agencies.  Key private-sector partners include the American Heart Association, the American Medical Association, the YMCA, other non-profit agencies, communities and health systems.

Preventing one million heart attacks by 2017 is an ambitious goal that will require work and a steady commitment to change from each one of us.  Visit Million Hearts to learn more about the steps you can take to help reach this national goal, and to enjoy a healthier lifestyle.  Additionally, take the pledge to be one in a Million Hearts!

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration.