to speed up the cycle of medical research culminated Tuesday in the filing of a bill called 21st Century Cures Act.
— stripped of its most controversial provisions to accelerate drug approvals, which the Food and Drug Administration and critics had said could compromise patient safety — headed to the U.S. House Energy & Commerce Committee for debate and markup Tuesday and Wednesday.
The sponsors of House Resolution 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 measure “a once-in-a-decade bill” for which this Congress would probably be remembered 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 said regulatory policies haven’t kept pace with biomedical discoveries, which exploded with the mapping of the human genome and other recent advances.
Rep. Jan Schakowsky, R-Ill., said at Tuesday’s committee hearing that she didn’t want resources to pay for the legislation to come from reductions in Medicare and Medicaid benefits.
