publication date: May. 1, 2015

NIH Slated to Receive $10 Billion Increase In Second 21st Century Cures Draft Bill

 

The House Committee on Energy and Commerce published the second “discussion draft” for a comprehensive bipartisan initiative aimed at streamlining development of drugs and medical devices.

The proposed legislation, called “21st Century Cures,” was launched April 30, 2014, and is led by Rep. Fred Upton (R-Mich.), chairman of the committee, and Rep. Diana DeGette (D-Colo.), chief deputy whip.

In addition to boosting NIH funding by $10 billion over five years and establishing a clinical trial data system for federally funded trials, the discussion draft includes provisions for developing the next line of antibiotics.

The bill includes a “placeholder”—a promise of language that will come later—for providing incentives for repurposing drugs for serious and life-threatening diseases and disorders.

The bill would require FDA to create a priority review program for breakthrough medical device technologies. A section of the draft legislation aims to provide clarity for developers of software products used in health management and medical care.

“It has become increasingly clear in recent years that our regulatory policies have not kept pace with innovation and there is much more we can be doing to provide that hope to folks. That’s what this bill does,” Upton said at a legislative hearing of the Subcommittee on Health April 30.

“This discussion draft, the product of eight hearings, more than two-dozen roundtables, … Continue reading 41-17 NIH Slated to Receive $10 Billion Increase In Second 21st Century Cures Draft Bill

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