The FDA Needs an Action Plan for More Inclusive Clinical Trials


More than 23 years ago, we met each other for the first time. Susan was a science advisor to the Congressional Caucus on Women’s Issues and Cindy was program director of one of the largest women’s health consumer group, the National Women’s Health Network. We were both upset about how little research was being done on women’s health issues, and together with many important allies and several determined female members of Congress, we worked to change the law to ensure that women’s health research could no longer be ignored.

We’re proud of what’s been accomplished since the National Institutes of Health Revitalization Act went into effect in 1993. Women and people of color are more likely to be included in clinical trials than they used to be.

Women’s health issues are no longer ignored, and we know a lot more about conditions like endometriosis, fibroids, interstitial cystitis, lupus, and TMJ than we used to. We also know a lot more about the natural course of menopause, how aging affects women, and how heart disease is and isn’t the same in males and females.

But, there are some important things we still don’t know about women’s health. All too often, we do not know how drugs and medical devices affect women and people of color. How can we not know the effect of medications and medical devices on women? Because, until now, the Food and Drug Administration (FDA) has only recommended, not required, pharmaceutical companies to look at women separately from men. We have more studies on women’s health conditions, and we have more women and people of color in studies, but we don’t have nearly enough information on how women fare, compared to men; nor do we know enough about how people of color fare.

Because women are less likely than men to be included in clinical trials, we often don’t discover if a drug or device is unsafe or less effective for women until after it is on the market being used by thousands of women, as was the case with Ambien (a sleeping medication). It was recently discovered that the FDA-approved dose of Ambien was too high for women—twice as high. The double dose made women more likely to be drowsy the next morning, putting them at risk of a car accident and other serious harms. But this is not just about a single drug: A 2001 study showed that eight in ten drugs recalled from the market posed a greater health risk to women than to men. The problem persists to this day, as many important studies still don’t include enough women or people of color. For example:

  • Only one-third of patients in clinical trials studying heart disease are women, despite the fact that heart disease is the leading cause of death for women in the United States. African-American women specifically are 40 percent more likely to die of heart disease than white women, according to the American Heart Association.
  • Two-thirds of people with Alzheimer’s disease are women, but most studies of Alzheimer’s disease have not been designed to evaluate differences based on sex or ethnicity. Among participants in four National Institute on Aging–funded Alzheimer’s Disease Cooperative Study trials, only about 6 percent of participants were African American and roughly 4 percent were Hispanic.
  • More women die of lung cancer each year than from breast, ovarian, and uterine cancers combined, yet women—particularly racial and ethnic minorities—are still less likely to be in these trials than white men and the data is unlikely to be analyzed for sex, race, or ethnic differences. According to data released at an international conference on lung cancer, 58 percent of lung cancer patients in the United States are men and 42 percent are women; however, only 32 percent of lung cancer trial patients were women. Moreover, African Americans develop lung cancer at a higher rate than Caucasians, but this group represented only 2 percent or fewer of lung cancer trial participants.

If not enough women and people of color are included in the studies, it is not possible to determine how they’re affected by the new drug or device. And without this information women, particularly women of color, can’t make informed decisions about the medical products available.

So, 23 years later, we are still working to make change. In 2012, we partnered with allies, including WomenHeart, the Society for Women’s Health Research, and the American Heart Association, along with the National Women’s Health Network, and successfully pressed Congress to pass legislation directing the FDA to ensure that companies seeking its approval include women and minorities in clinical trials, evaluate the safety and effectiveness data by sex, race, and ethnicity, and make this information (or lack of information) publicly available.

Last summer, the FDA released a report evaluating how well women and minorities are included in clinical trials and whether the data is analyzed for differences in safety or effectiveness based on sex, race, and ethnicity. Unfortunately, the report showed that the research submitted to the FDA still is not adequate when it comes to evaluating sex and gender differences or differences due to race and ethnicity. Even though women and people of color are included in trials, they aren’t being included in sufficient numbers to actually get good information.

Thankfully, this report is not the end of the line. In August, the FDA is due to release an action plan to improve the data it gets about medical products for women and communities of color. We are urging the agency to take this opportunity to develop and implement an action plan that truly addresses the deficiencies revealed by its report and meets the needs of women and communities of color. Specifically, we urge the FDA to address the lack of evidence on sex, race, and ethnicity-specific effects of drugs and medical devices, including the following requirements in its action plan:

  1. Companies must not only include women and minorities in clinical trials submitted to the FDA, but ensure there are enough people in the trial to analyze it based on sex and on race and ethnicity.
  2. Companies and the FDA must use this information to evaluate the safety and effectiveness of drugs and devices based on sex, race, and ethnicity.
  3. Information on sex, race, and ethnicity-specific safety and effectiveness must be made publicly available and included on the labels of drugs and devices.
  4. The FDA must reject applications that do not include sufficient information about women and people of color.

The FDA has an important opportunity to improve public health by requiring companies to do the right thing. We will continue to push the agency to release a strong action plan, and we ask you to join us in urging the agency to stand strong and ensure that new drugs and devices are only approved when critical data on sex differences are available, so that women and health-care providers can make informed decisions about their health care.

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To schedule an interview with and contact director of communications Rachel Perrone at rachel@rhrealitycheck.org.