In comments on the draft 21st Century Cures Act, the Federation of American Societies for Experimental Biology (FASEB) expressed concerns about duplication of regulations, micromanaging research, and important sections that were left unfinished or missing altogether. Duplicating work already underway, the draft legislation proposes to establish a National Institutes of Health (NIH) working group to study administrative burden, an issue that is already being addressed by extra- and intra-agency groups. Other sections micromanage agency operations. Provisions to narrowly target funding and force additional layers of grant review and could hinder scientific progress. The bill did not alleviate travel restrictions for federal researchers and clinicians, nor did it grant NIH multi-year budget authority that would significantly improve its spending efficiency.
The 21st Century Cures initiative is an effort spearheaded by Energy and Commerce Committee Chairman Fred Upton (R-MI) and Representative Diana DeGette (D-CO) to speed the delivery of treatments and cures to the public and ensure that the U.S. remains a world leader in medical innovation. After months of gathering feedback from stakeholders representing all facets of the cures ecosystem, the committee released the first draft of the 21st Century Cures Act in January. The nearly 400-page document covers myriad topics ranging from advancing telemedicine opportunities to modernizing clinical trials to supporting research on new vaccines.
FASEB is now preparing suggestions to improve the sections with which it took exception. The Energy and Commerce Committee continues to accept feedback on 21st Century Cures at email@example.com.