The Lupus Foundation of America (LFA) plays a vital role in shaping policies that improve the lives of people affected by lupus. Led by our advocacy and government relations department, we work with elected officials and engage federal agencies such as the Food and Drug Administration (FDA) whose policies can significantly impact the development of treatments for lupus and access to those treatments.
In September, the LFA responded to the FDA’s request for input (also known as a comment period) on their draft guidance on the Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. The LFA provided the agency with information to support the inclusion of pregnant and breastfeeding women in clinical trials, a topic that is especially important in lupus. Specifically, the LFA supports ways in which pregnant women can be included in clinical trials, including ways to collect better data, recruit and retain people participating in clinical trials, and reduce risks for women who take part in studies.
When this guidance document is finalized by the FDA it will provide much needed direction to drug developers on when and how to safely include pregnant and breastfeeding women in clinical trials. Right now, pregnant and breastfeeding women are often excluded from clinical trials or forced to leave a trial if they become pregnant. Moreover, women of childbearing age may be required to take birth control in order to participate in a trial. These policies can significantly limit the number of women who participate in trials and create barriers to participation, resulting in trials that may not be representative of the lupus population. They also can leave big gaps in what we know about how medicines affect pregnant women, especially when it comes to safety, dosing, and side effects.
For women with lupus, this issue is especially critical considering that 80% of new lupus diagnoses are made during the childbearing years. That’s why the LFA strongly supports the FDA’s efforts to develop guidance that makes it easier to include pregnant and breastfeeding women in clinical trials and to do so earlier in the drug development process—especially for drugs likely to be used by women of childbearing age. Without this data, doctors may be left making decisions with incomplete information, which may put pregnant or breastfeeding women at risk of receiving treatments that don’t fully meet their needs. Clinical trials that exclude pregnant and breastfeeding women don’t tell the whole story; new FDA guidance can be an important step forward to ensure that lupus treatments are safe and effective for everyone who needs them, including pregnant women with lupus.
Read more in our comments to FDA.
The Lupus Foundation of America advocates at every level of government to support people living with lupus and ensure that their voices are heard by federal and state policymakers on Capitol Hill, in Washington, DC and in state capitols across the country. Read more about our lupus advocacy efforts here.
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