The U.S. House of Representatives has approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77 and now goes to the U.S. Senate for consideration. This legislation would reauthorize the National Institutes of Health, focus efforts to increase strategic investments and medical research at the NIH and modernize the approval and regulatory process for new drugs, biologics and medical devices at the FDA. On May 21, 2015, the bill passed the House Energy and Commerce Committee by a vote of 51–0.
“America has historically been a leader in medical innovation and breakthroughs, but government rules and regulations threaten our leadership in health care innovation. Our goal must be to create a regulatory environment where American innovators are not at a competitive disadvantage to foreign companies. The 21st Century Cures Act speeds access to new medicines and treatments by applying the right incentives and taking a more thoughtful approach to product approvals. The bill protects current US medical and biomedical jobs while spurring the creation of new medical research companies. This legislation brings hope and medical treatments and cures to many patients and their families who have run out of options,” said Congressman Kevin Cramer, a cosponsor of the act.
Currently, it takes on average 15 years for the FDA to approve a new drug. This legislation eliminates red tape and regulations to get new treatments to patients and their families sooner. Similar reforms will occur at the NIH, liberating scientists and researchers from paperwork allowing them to focus on research and not bureaucracy.
The legislation also establishes a temporary Innovation Fund that is fully offset and retains the critical role of the Appropriations Committee to determine the specific biomedical spending priorities through the regular appropriations process each year of its five-year life. Moreover, while the 21st Century Cures Act includes five years of targeted, offset investments in health research and innovation, the bill also includes permanent entitlement changes that will yield billions in savings. These entitlement changes will lead to billions in additional savings in Medicare and Medicaid.