Long-awaited Cures 2.0 bill unveiled

Regulatory NewsRegulatory News | 16 November 2021 |  By 

Two years after beginning work on a follow up to the 21st Century Cures Act, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday introduced their Cures 2.0 bill.
The 173-page bill, intended to supercharge medical innovation, would provide new funding for programs at the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid services (CMS), as well as create the $6.5 billion Advanced Research Projects Agency for Health (ARPA-H). A concept paper outlining the White House's vision for ARPA-H was published in Science alongside the discussion draft of the Cures 2.0 package earlier this year. (RELATED: Upton and DeGette begin work on Cures Act reprise, Regulatory Focus 25 November 2019; Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H, Regulatory Focus 23 July 2021)
"Diseases such as cancer, diabetes, Alzheimer’s and ALS don’t care if you’re a Democrat or Republican. They affect all of us the same. By creating ARPA-H, we will be bringing together some our nation’s greatest minds to help find cures to these devastating diseases. And we will – for the first time – be putting the full weight of the federal government behind the ongoing efforts to end these terrible illnesses as we know them – which is a mission that all of us should be able to get behind,” Upton and DeGette said.
The bill is largely similar to the discussion draft and contains a dozen provisions that would affect FDA, including measures to boost clinical trial diversity, improve the collection of patient experience data in clinical trials, establish two new intercenter institutes within FDA, and provide grants for novel clinical trial designs and other drug development innovations.
Other tenets of the bill include requiring FDA to submit reports or issue guidance on other topics such as digital health, real world evidence, and cell and gene therapies.
The bill also retains a provision that would modify FDA’s breakthrough therapy and regenerative medicine advanced therapy (RMAT) programs to allow sponsors to request designation before or after a new drug application (NDA) or biologics license application (BLA) is submitted. Additionally, the draft bill calls for FDA to issue guidance clarifying how, and by when, sponsors must submit chemistry, manufacturing, and controls (CMC) information for products subject to one of FDA’s expedited pathways.
A new section not previously included in the discussion draft would also direct the FDA commissioner to convene a meeting with drug and medical device developers, patients, and other stakeholders to gather recommendations on approaches to encourage the adoption of decentralized clinical trials.
Statement, Bill


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