FDA Moves Toward More Women in Research Trials

By Victoria Cleveland, NOW Government Relations Intern

The Food and Drug Administration (FDA) recently issued guidelines suggesting that more women, as well as greater racial, ethnic and age diversity, be included in research trials by companies
submitting drug and device applications for review and approval. Unfortunately, the agency stopped short of requiring that companies have greater diversity in their study populations and to study the drug’s effects in those sub-populations.

Last May, NOW submitted comments to the FDA urging that they require that companies use trial subjects that better reflect the nation’s diversity. The typical clinical trial subject is a white male under age 55. The inadequate representation of women in clinic trials has been known for decades. The U.S. population is changing dramatically: in 2012, Hispanics made up 17 percent of the U.S. population, African Americans 13 percent, and person’s over 65 constituted 12 percent. The “baby boom” generation totaled 25 percent of the population alone. These subgroups — especially women — are all underrepresented in drug trials, and must be better included to prevent dangerously wrong dosage recommendations.

handful-of-pills-lg-new-mdIt has been documented that response to drugs varies in different sexes, ages, and races, as in the case of aspirin. In 1989, a study reported that aspirin reduced a person’s risk of heart disease. It took 15 years for researchers to study the drug’s effect on women, which led to the discovery that it did not lower women’s risk.

Another difference in how men and women metabolize drugs can be found with Ambien, a popular sleep aid. Early research showed that women actually metabolize it at a slower rate, therefore were t
aking a higher dosage of the drug than was safe. However, these findings were ignored; women were still under the influence of the drug the next day, and many car accidents were associated with the women’s use of Ambien. It took the FDA 20 years to change the recommended dosage for women.

This August, the FDA released an action plan which recognizes the lack of diversity in research trials, and puts forth guidelines for more inclusion of currently underrepresented groups, as well as allowing subgroup-specific data to be more widely available on product labels and for medical practice. As long as the FDA’s action plan centers on guidelines, rather than requirements, companies will likely uphold the status quo and continue using mostly white men under 55 for their research trials. The lack of diversity in trial subjects, as well as potentially harmful, one-size-fits-all medical product labels will continue, until the FDA makes such measures necessary for product approval.

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