While we all agree that medical innovation is vital for improving the health of people in this country, innovation that occurs at the cost of patient safety is something we can all live without!
Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), two members leading the initiative, promise the bill will be good for patients - and we disagree! The 21st Century Cures Act may be largely nonpartisan in nature, but many public health and consumer advocate groups, including the Network, are deeply concerned about the implications of the bill.
The Network has worked long and hard in partnership with the women’s health community to demand the greater inclusion of women in clinical trials for all FDA approved drugs and devices. We have also stressed the need for demographic data, analysis of sub-group differences, and availability of accessible and consumer-friendly information that women and their health care providers can use to make informed health care decisions. The 21st Century Cures Act would speed medical innovation by allowing shorter trials and smaller studies on more homogenous groups of people - the opposite of everything we have worked so hard to secure!
We know that women, people of color, and people over 65 metabolize certain medications differently. Allowing shorter, smaller studies means that potentially harmful drugs and devices may not be adequately tested in these sub-groups. This bill would directly counter our previous work to improve the inclusion of women and other demographic subgroups in clinical trials, and ultimately harms health and decreases safety.
The bill’s sponsors have taken to social media asking people to express what the 21st Century Cures Act will mean to them by using the hashtag #CuresIn4Words. Ours would be “patient safety over politics” - what will yours be? Help support our work to ensure patient and consumer safety remain at the forefront of medical innovation by making a generous gift today!