OR WAIT null SECS
In laying out its formal budget proposal for fiscal year 2022, the Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year. While Congress will reject or modify many of the specifics, the federal government’s remarkable success in combatting the COVID-19 pandemic continues to generate bipartisan support for advancing biomedical research and public health and safety.
FDA’s oversight and guidance in speeding the development of critical COVID vaccines, diagnostics and therapies is rewarded with additional funding to continue and strengthen those capabilities. The new spending plan requests $6.5 billion for the agency, up 8%, with $3.6 billion in public appropriations and $2.9 billion in user fees paid by industry.1 The added $344 million, according to the Alliance for a Stronger FDA, is allocated primarily to three main areas: critical public health infrastructure, including data modernization and expanded laboratories, facilities and staff; core safety programs for food and medical products and global supply chains; and ensuring public health by increasing secure inspections, promoting health equity, and addressing the opioid crisis.2
Among the specifics, FDA seeks $19 million to enable its field inspection program to carry out site visits delayed by the pandemic and to avoid a reduced frequency in both domestic and foreign inspections going forward. To help end the opioid crisis, FDA would gain $38 million to support research for developing overdose reversal treatments and new non-opioid pain medications and to devise systems to better track and manage opioid use.
For several years now, FDA has emphasized the need to modernize its data and communications systems for medical products and food, and the new budget may finally advance its Enterprise Technology and Data modernization efforts. An additional $45 million would support wider use of artificial intelligence and advanced IT systems to enable data sharing across product centers and ease communications among agency offices, streamline core business processes, and better track medical product manufacturing to better anticipate shortages.
The budget plan also cites the need for legislation to make permanent certain temporary policies that will expire with the end of the current public health emergency. This includes authority to require medical device manufacturers to notify FDA of product shortages, to request records and other information from medical device makers and clinical research sites in advance or “in lieu of” a physical facility inspection, and to require data and studies from drug manufacturers to extend product expiration dates as a way to prevent product shortages.
The Biden spending plan further outlines initiatives to enhance public health more broadly, including programs to address gun violence and the opioid epidemic and to continue investment in biomedical research to prepare for future pandemics. Reforms that allow Medicare to negotiate prices with drug manufacturers and impose rebates on companies that raise prices faster than inflation would save more than $500 billion over 10 years, the analysts calculate, but without offering many specifics for implementing such contentious changes.
While the National Institutes of Health (NIH) would see a hefty 22% rise in funding for a $50.5 billion 2022 budget, $6.5 billion of that increase would fund the new Advanced Research Projects Agency for Health (ARPA-H) within NIH, a hot-button proposal that has raised many questions. Designed as a parallel to the Defense Department’s Defense Advanced Research Projects Agency (DARPA), stakeholders already are debating if ARPA-H should reside within NIH or be independent, how it could advance “transformational” research issues for multiple diseases, and how its projects would involve private sector R&D and technology transfer. A review of the ARPA-H initiative from the Congressional Research Service summarizes these issues and options for going forward.3
The administration also seeks an $8.5 billion budget for the Centers for Disease Control and Prevention (CDC), a notable $1.5 billion increase (up 21%) in funding for this usually neglected agency. And the Biomedical Advanced Research and Development Authority (BARDA) would gain $227 million for a $823 million spending plan to build the national stockpile and help prepare for future pandemics.
Congressional debate on FDA’s budget will begin June 10 at a hearing before the Senate Appropriations subcommittee that deals with the agency. Acting commissioner Janet Woodcock will make the case for the administration’s spending plan and FDA program priorities, and again before the relevant House appropriations subcommittee. But the main decisions on budget support for the agency will turn on broader revenue and spending issues for federal programs as the nation continues to promote economic growth and public health recovery.