FDA Meeting – Clinical Trial Diversity

Statement of Sarah Christopherson, Program Director

National Women’s Health Network

February 29, 2016

Food and Drug Administration Safety and Innovation Act 907 Public Meeting:

Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data

 

My name is Sarah Christopherson, and I am the Program Director at The National Women’s Health Network, a nonprofit advocacy organization that works to improve the health of all women. We are supported by our members and, by choice, we do not accept financial support from drug companies or medical device manufacturers.

 

Since the Network’s founding 40 years ago, we have brought the voices, concerns, and needs of women consumers to policy and regulatory tables, including the FDA, advocating for medical products that meet women’s real life needs and for a drug and device process that reflects women’s lived experiences.

 

We appreciate the chance to speak today, however briefly, and commend the FDA and particularly the Office of Women’s Health (OWH) and the Office of Minority Health (OMH) for their extensive work to develop the Action Plan. We know both offices have a number of commitments under the Action Plan—even as their budgets have remained flat. We strongly support efforts to appropriately fund these offices as they work to overcome barriers to clinical trial participation by women and people of color.

 

However, we have strong concerns that today’s agenda suggests a philosophical move by FDA as a whole away from ensuring that women, people of color, and the elderly are appropriately represented in clinical trials for new drugs and medical devices.

 

Sex, race, ethnicity, and age are now—and will be for years to come—the best proxies we have for determining how widely-used drugs and medical devices are likely to affect certain individuals. The failure of industry to adequately test the efficacy and safety of a new drug or device on these demographic subgroups cannot be conveniently swept under the rug in the hopes that new technology will make such study unnecessary at some point in the future.

 

We already know what happens when clinical trials lack sufficient diversity. When women are underrepresented, we don’t discover that a drug or device is unsafe or less effective for women until after it is on the market being used by thousands of women. Real-world examples abound. In 2013, the FDA had to cut in half the approved dose of the sleeping drug Ambien for women. But only after a startling number of car accidents and sleep-driving incidents were linked to the drug.

 

The Ambien example highlights how adequate testing prior to approval and widespread use saves not only the lives of those taking a drug, but also affects the public at large. But Ambien was not an isolated incident. A 2001 study showed that eight in ten drugs recalled from the market posed a greater health risk to women than to men.

 

The FDA has the power to do more than simply encourage participation. The FDA can and should refuse to approve new drugs and devices when there is insufficient trial diversity.  Thus we want to state unequivocally that companies must not only include women and people of color in clinical trials submitted to the FDA, they must ensure there are enough participants to analyze results based on sex, and on race and ethnicity. And the FDA, in turn, must reject applications that do not include sufficient information about women and people of color. Until that happens, manufacturers will have little incentive to improve.

 

We applaud the FDA for the important steps it has taken to increase transparency, such as drug Snapshots. Though we continue to urge the FDA to make the Snapshots retroactive, to include devices, and to fill current gaps in what is reported and how demographic categories intersect, we believe that women benefit from the ability to find out whether a drug has been tested on people like them.

 

However, when we look at the Action Plan itself and the agenda for today’s meeting, we’re concerned by the lack of specificity for key goals, particularly those labeled as intermediate. For example, the plan states variously that “the FDA” and “we” “plan to work, to the extent possible, towards better standardization of data collection categories for age, racial, and ethnic groups in submitted applications.”

 

We strongly support this goal. But we question what concrete actions FDA is proposing to meet it beyond being “prepared to work with stakeholders” and who specifically has been assigned to follow through. “Intermediate term” can easily become “never” if there aren’t clear project leaders and benchmarks.

 

Thank you.