ACT-AD has submitted comments on the 21st Century Cures Act, which was approved by the House Energy & Commerce Committee this month, to committee members Fred Upton (R-MI) and Diana DeGette (D-CO). This is a follow up to a letter that was sent earlier this year.
ACT-AD noted that the bill, if fully funded, could improve various aspects of the biomedical research and regulatory approval processes. We were also “encouraged by recent reports of [the committee’s] commitment to ensuring our federal agencies have the resources they need to carry out the increased responsibilities included in the 21st Century Cures Act.”
ACT-AD also offered comments on specific provisions in the Title II: Development section of the bill, including:
- Subtitle A-Patient-Focused Drug Development
- Subtitle B-Qualification and Use of Drug Development Tools
- Subtitle D-Modern Trial Design and Evidence Development
- Subtitle P-Improving Scientific Expertise and Outreach at FDA
Another positive development in regard to the bill was the inclusion of the FDA Safety Over Sequestration Act (FDA SOS Act), which exempts the Food and Drug Administration (FDA) user fees from sequestration. This is a provision that members of ACT-AD supported as stand-alone legislation.
The bill now goes before a full vote in the House.