Today, President Trump signed into law the bipartisan Consolidated Appropriations Act of 2017, also known as the omnibus spending bill. This legislation provides considerable funding to support the implementation of the 21st Century Cures Act, which will accelerate safe and effective treatments and cures for patients.
The bill provides a $2 billion increase in funding for the National Institutes of Health (NIH) to support important research, including $352 million for NIH Innovation Projects authorized by the 21st Century Cures Act. Within the Innovation Projects, $300 million is allocated for cancer research, $40 million for precision medicine, $10 million for research on neurological diseases, and $2 million for regenerative medicine. Also included in the spending bill was a $39 million increase in discretionary funding for the Food and Drug Administration (FDA), at least $10.9 million of which is dedicated to medical product safety and precision medicine initiatives outlined in the 21st Century Cures Act. These funding streams—along with industry user fees—play a critical role in accelerating the discovery, development, and delivery of new cures and treatments to Americans.
The bill provides a $2 billion increase in funding for the National Institutes of Health (NIH) to support important research.
Next week, the Senate Health, Education, Labor, and Pensions (HELP) Committee is expected to mark-up the FDA Reauthorization Act of 2017, which is bipartisan legislation reauthorizing FDA user fees for prescription drugs, devices, and biosimilars over the next five years.
BPC’s just-released report, Accelerating the Development and Delivery of Safe and Effective Cures for Patients in the United States, offers recommendations to help inform Congress as it finalizes and passes legislation in the coming weeks.
The discussion draft of the FDA Reauthorization Act of 2017 released by leaders of the Senate HELP Committee and the House Energy and Commerce Committee on April 14, 2017, references and implements several provisions that will help patients in need and improve U.S. competitiveness.
These provisions will increase scientific expertise and capacity at the FDA, accelerate the use of real-world evidence and other drug development tools to improve regulatory decision-making, incorporate the patient voice into the medical product development process, and advance the development of combination products. Such provisions align with commitments negotiated between FDA and industry in 2016 and BPC recommendations contained in the report, Advancing Medical Innovation for a Healthier America. They also build upon, complement, and support provisions of the 21st Century Cures Act passed nearly unanimously with bipartisan support in December 2016.
BPC also recommends that Congress consider legislation in 2017 on other issues identified by BPC in its previous recommendations, including those related to clarifying regulatory authority associated with laboratory-developed tests, supporting implementation of a national registry for regenerative cell therapies, and clarifying and increasing the scientific exchange of information to inform off-label use of approved medical products.
Progress has been made on these additional recommendations. The FY2017 bipartisan spending bill signed into law today strongly encourages the FDA to continue to work with Congress to address the issues and concerns regarding regulation of laboratory-developed tests. Clarification of scope and additional funding for the Stem Cell Therapeutic Outcomes Database authorized in the Stem Cell Therapeutic Research Act of 2015 can be accomplished through FY2018 appropriations, discussions of which will get underway this month.
Finally, the Medical Product Communications Act introduced in March 2017 by Rep. Morgan Griffith contains provisions that would enable the scientific exchange of information to support not only clinical decision-making, but also decision-making by those making health care resource or utilization management decisions about medical products for patients, which is consistent with BPC recommendations.
Funding important provisions of the 21st Century Cures Act in the FY2017 Omnibus Spending bill will have a significant and positive impact on patients and our nation’s ability to effectively compete globally. The same goes for the FDA Reauthorization Act which will be marked-up next week. Rapid completion and passage of user fee legislation before the August recess is necessary to support the FDA’s ability to review and approve new therapies and fully implement key components of the 21st Century Cures Act.