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After a two-year effort, Congress took a major step forward toward passing extensive legislation titled The 21st Century Cures Act to accelerate the development of and access to treatment for rare diseases and other conditions in need of biomedical innovation. The bill aims to boost funding for research at the National Institutes of Health and for drug and device review and approval processes at the Food and Drug Administration, while also addressing policies that will positively impact maternal health and address mental health as well as opioid abuse. The legislation passed the House of Representatives in late November, and it is expected to pass the Senate and be signed into law by President Obama in early December.
The legislation covers two areas directly tied to the Preeclampsia Foundation’s advocacy efforts. It addresses federal policy for the protection of human subjects, also known as the “Common Rule,” which establishes research parameters for clinical trials. Earlier this year, the Foundation submitted comments to the Department of Health and Human Services requesting support to improve research requirements to advance clinical trial work, particularly in a field like preeclampsia research. The legislation also addresses the glaring lack of existing research into the safety of prescription drugs and other medications used by pregnant and lactating women, forming an interagency task force to address this significant knowledge gap.
The Foundation is a member of the Coalition to Advance Maternal Therapeutics, a group of national advocacy organizations that has been working to educate Congress about the need to address the lack of data and information about the implications on both maternal and infant health and well being. The Foundation wants to ensure the new task force will advance efforts to establish new safety labeling for prescription drugs while also supporting a pathway for the discovery of safe and effective therapeutics for pregnant women to manage conditions like preeclampsia.