Sen. Bill Cassidy, R-La., issued a report Tuesday on how the Food and Drug Administration can be modernized to do things like encourage medical research.
The nearly 20-page report lists more than a dozen ways the FDA and Congress can improve how the agency operates.
"Biomedical innovation holds enormous promise for the American people ... But 'innovation' is meaningless unless it creates products that actually help patients," Cassidy said.
"While many parts of FDA work well, unnecessary bottlenecks slow patients and consumers getting the products they need."
Cassidy, chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, said the panel's recommendations are directly in line with President Donald Trump's mission to improve the health of American children and families.
"Ultimately, it should be easier to make Americans healthy by empowering them with the tools and information they need to make healthy choices and live better lives," he said.
"The HELP Committee looks forward to coordinating with FDA under its new leadership to promote patient access, accelerate U.S. competitiveness, and improve the health of American families," Cassidy added.
Recommendations include delivering affordable, lifesaving cures to patients more quickly by eliminating red tape and increasing predictability in the FDA's review process.
They also call for integrating artificial intelligence and other technologies into the review process to speed approvals while maintaining safety standards.
The recommendations emphasize ensuring families have access to safe, healthy foods by strengthening the FDA's Human Foods Program, which Cassidy said is crucial to achieving Trump's goal of ending the chronic disease epidemic in the United States.
They propose keeping lifesaving medical research in the United States by streamlining clinical trials and encouraging collaboration between the FDA and developers.
The recommendations also call for strengthening the FDA workforce by incentivizing top American scientists and experts to serve at the agency.
Cassidy, a physician, said in the report that he wants to "initiate a collaborative, bipartisan process for reforms to strengthen the FDA and get better and more affordable products to patients faster."
He said unpredictable FDA reviews too often affect the approval of drugs for rare diseases.
"FDA teams can differ greatly in the extent to which they require testing or impose standards that are not calibrated to the relevant risks," Cassidy wrote in the report.
"The perceived disconnect between the forward leaning rhetoric and thought leadership of senior FDA officials and cautious reviewer practice creates further unpredictability."
Sam Barron ✉
Sam Barron has almost two decades of experience covering a wide range of topics including politics, crime and business.
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