10 things to know about the 21st Century Cures Act

On Friday July 10, the House of Representatives passed H.R. 6, also known as the 21st Century Cures Act, which supports healthcare innovation infrastructure. Following the passage of the bill in the House, the bill is now in the Senate.

Here are 10 things to know about the 21st Century Cures Act.

1. The bill was introduced May 2015 in the House of Representatives by Rep. Fred Upton (R-Mich.), chairman of the House Committee on Energy and Commerce.

2. Rep. Diana DeGette (D-Colo.) was a co-sponsor. With one Republican and one Democrat spearheading the bill, 21st Century Cures has been heralded for its successful bipartisan efforts to improve the pace of healthcare innovation.

3. The American Society for Biochemistry and Molecular Biology in a statement applauded the House of Representatives' bipartisan approach to the bill, encouraging more bipartisan action in the future. The statement from the society's public affairs director Benjamin Corb read:

 "The ASBMB applauds Rep. Fred Upton and Rep. Diana DeGette for their bipartisan cooperation in drafting, managing and now passing the 21st Century Cures Act. And we applaud the bipartisan support from the House of Representatives for biomedical research broadly — and the NIH specifically.

Today should mark the beginning — not the end — of Congressional actions aimed at supporting the nation's biomedical research enterprise. We strongly encourage both chambers to pass appropriations bills that adequately fund the NIH today, and into the future."

4. The House of Representative approved the 21st Century Cures Act with a vote of 344-77.

5. Central to the initial proposed legislation was the regulatory process the U.S. Food and Drug Administration had in place for drug approvals, which Reps. Upton and DeGette called "the relic of another era," according to a New York Times report.

6. After several revisions, the final bill still amends the Federal Food, Drug and Cosmetic Act to revise the drug approval process by allowing patient experience data to be considered in risk-benefit assessments of new drugs, requiring the FDA to qualify drug development tools, allowing the FDA to use data previously submitted for a different purpose to expedite the development of certain drugs and establishing a streamlined data review program for drug approvals for additional indications.

7. Additionally, 21st Century Cures extends funding for the National Institutes of Health for the next five years, totaling $8.75 billion. Additionally NIH will host a new Cures Innovation Fund specifically dedicated to breakthrough biomedical research. Funding would help support initiatives such as President Obama's Precision Medicine Initiative to enhance personalized medicine and genomics to find more efficient, effective treatments.

8. The FDA will also see a funding boost of $550 million over the next five years to help address the drug approval process among other initiatives.

9. However, the prospect of expedited FDA approvals has been met with some resistance. For example, Jerry Avorn, MD, and Aaron Kesselheim, MD, wrote a perspective piece in the New England Journal of Medicine suggesting an expedited FDA review process introduces questions regarding the safety and efficacy of medical products.

10. 21st Century Cures is also a bill supporting jobs, according to Rep. Upton. In a summary sheet of the bill, Rep. Upton said, "The United States has led the global medical device and biopharmaceutical industries for decades, helping us become the medical innovation capital of the world and causing China and others to try to take our innovation and jobs…The policies in HR 6 will help us fight off foreign competitors so we can keep these jobs, and add more, here at home." He said that by increasing funding to NIH, the agency will be able to support jobs at institutions across the country.

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