Safe & Effective Medicines

For far too long, pregnant and breastfeeding women have been overlooked in clinical research. A history of treating these women as “vulnerable” has led to exclusion from studies, creating a major gap in access to safe and effective drug options.

Pregnant and breastfeeding women are often left with unanswered questions about the safety and effectiveness of their medications, and are often forced to make an impossible choice: Do they continue treatment they are not sure is safe, or do they stop treatment to avoid risk – which may end up being more harmful to both themselves and their unborn child?

Thankfully, progress is being made toward addressing this challenge. The 21^st Century Cures Act called for the establishment of a Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC) to address these gaps in research and produce recommendations for the Secretary of Health and Human Services (HHS) on how to improve clinical research and include pregnant and lactating women in clinical research studies.

Over the past two years, the PRGLAC task force held public meetings to discuss challenges and develop recommendations for solving this problem. And because maternal and child health is at the forefront of our mission, the Elizabeth Glaser Pediatric AIDS Foundation tracked this process and provided input to the task force on what should be included in their recommendations. EGPAF cares deeply about this issue given the direct link to HIV – both making sure therapeutics are studied and approved for use in pregnant and breastfeeding women to protect the mother’s health and also to prevent transmission of HIV to their child.

To help draw light to this ongoing challenge and the important work of the PRGLAC task force, EGPAF partnered with Treatment Action Group (TAG), the Society for Maternal-Fetal Medicine (SMFM), and the HIV/AIDS Network Coordination Women’s HIV Research Collaborative (WHRC) to host a two-part webinar series in 2018, highlighting the importance of including pregnant and breastfeeding women in research. Following these webinars, EGPAF worked with partners on a public statement, presenting specific recommendations for the inclusion of pregnant and breastfeeding women in research, with endorsement from more than 30 organizations and individuals. EGPAF presented this comment in writing and in person to the PRGLAC Task Force in May 2018.

In September 2018, after nearly two years of consideration, the PRGLAC Task Force submitted their final recommendations – many of which are in line with the public statement supported by EGPAF –  on how to address these gaps and improve research on therapeutics for pregnant and breastfeeding women. In March of this year, the Secretary of Health and Human Services announced his intention to implement the recommendations and extend the Task Force for another two years. This monumental achievement means that protection and care for pregnant and breastfeeding women will remain a global health priority – in fact, the next meeting of the PRGLAC task force is scheduled for this month.

EGPAF is proud to support the work of the PRGLAC Task Force and is encouraged by the actions of the Secretary of HHS to uphold the recommendations. We will continue to push this issue forward and help improve access to safe and effective medicines for moms everywhere.