FDA Funding Bill Mandates Clinical Trial Report
The House Committee on Appropriations has advanced fiscal year 2022 funding legislation that includes several provisions for clinical research, including efforts to increase clinical trial diversity and study the effect of COVID-19 on trials.
The committee report that accompanies the bill makes several requests of the FDA, including asking the agency to focus on more innovation and inclusion in trials for Alzheimer’s disease.
“Due to lack of diversity in clinical trials, those at the greatest risk may not be as well served by new treatments,” the committee wrote, adding that it “encourages FDA to increase efforts to make Alzheimer’s clinical trials more inclusive, innovative and to conduct necessary outreach to underrepresented populations.”
The committee also calls for the FDA to deliver a report within 90 days of the funding bill’s passage on the impact of COVID-19 on clinical trials, especially those for drugs intended to treat rare diseases.
Overall, the appropriations bill would increase nonuser-fee funding to the FDA by $257 million to $3.45 billion in fiscal year 2022. With user fees included, the FDA would receive total funding of close to $6.3 billion for fiscal 2022.
The fast-moving bill is on its way to the House floor with a vote expected in July. Senate Appropriations Committee Chair Patrick Leahy (D-Vt.) has said he wants to get started on an appropriations bill before the Aug. 9 recess.
Read the text of the House funding bill here: https://bit.ly/3dXXA1N.
Read the House Appropriations committee’s report on the bill here: https://bit.ly/3xysMwd.