House committee considers DeGette bill to speed medical research

A year-long bipartisan initiative to speed up the cycle of medical research culminated Tuesday in the filing of a bill called 21st Century Cures Act.
The bill, stripped of its most controversial provisions to accelerate drug approvals, which the FDA and critics had said could compromise patient safety, headed to the House Energy & Commerce Committee for debate and markup Tuesday and Wednesday.

Sponsors of H.R. 6, Reps. Diana DeGette-D-Colo., and Fred Upton, R-Mich., say they have bipartisan agreement to deliver $10 billion in new resources for the National Institutes of Health over five years.
In her opening statement Tuesday, DeGette said the comprehensive legislative effort covers the full cycle of discovery, development and delivery of new treatments and cures.

Rep. Joe Barton, R-Texas, called the bill "a once-in-a-decade bill," and likely what this Congress would be remembered for in 10 years. Other committee members echoed that the bill exemplifies how Congress should work.
The act, DeGette said, would help new scientists begin research, improve collaboration among researchers, modernize clinical trials and streamline approval processes for drugs and medical devices. It also would fast-track approval for antibiotics, create better disease surveillance and databases, advance the Obama administration's initiative on precision medicine and refine policies for vaccine development.

DeGette and Upton spent more than a year spearheading forums, roundtables and hearings with patients, providers, regulators and researchers around the country— accepting more than 100 issue papers from the medical community — before introducing the legislation.

"There was a remarkable degree of consensus about what needed to be done," DeGette said in a recent interview with The Denver Post.

"The biggest challenge we have is to get the bill passed by the House this summer, and to get it out of the Senate by the end of the year."

DeGette said regulatory policies haven't kept pace with biomedical discoveries, which exploded with the mapping of the human genome and other recent advances.
"This will help the U.S. keep its pre-eminence in the world in biomedical research," DeGette said.

Rep. Jan Schakowsky, R-Ill., said at Tuesday's committee hearing she didn't want resources to pay for the legislation to come from reductions in Medicare and Medicaid benefits.