U.S. Rep. Diana DeGette released her blueprint for a “Cures 2.0” bill, an update to the 21st Century Cures Act of 2016 that would address clinical trials, modernization of the U.S. Food & Drug Administration, and pandemic preparedness in the future.
“We’ve seen a record number of new drugs approved, including new generics, which have helped lower health care costs for millions of Americans. And we’re on the cusp of finding a cure for sickle cell,” said DeGette and her co-sponsor Rep. Fred Upton, R-Mich. “But despite these successes, there’s still much more work to be done.”
The roadmap outlines six areas of focus, developed after the representatives received nearly 500 comments. Title I of the bill would pertain solely to pandemic response, requiring the executive branch to deploy “a national testing [and] data sharing infrastructure” as well as a “vaccine, therapeutic, and medical supply readiness strategy to mitigate current and future pandemics.” The title singles out those with rare diseases for special financial support and proposes greater vaccine education and confidential, computerized monitoring of vaccination status.
Among other features, the bill would expand access for Medicaid patients to clinical drug trials and require the FDA to publish demographic data about those participating in trials. The FDA would also need to create guidance for use of digital health technology in treatment trials and for evidentiary standards in evaluations of breakthrough drugs.