Federal Budget Bill Boosts FDA Funding, Supports New Research Institute

After months of negotiations, Congress approved a massive federal government spending package last week, spurred by bipartisan support for including $13.6 billion in aid for Ukraine. The $1.5 trillion omnibus funding bill for fiscal year 2022, which began Oct. 1, 2021, increases funds to combat the opioid crisis and extends telehealth provisions, while also directing resources to a broad range of programs to advance health and medicine.

The measure increases FDA’s budget by $102 million to $3.3 billion in discretionary budget authority. FDA’s total funding amounts to $6.1 billion, with almost half of that—$2.8 billion— provided by approved user fees. The boost in federal funds is smaller than proposed earlier by Congressional committees, but sufficient to “reflect continued Congressional support for a strong, well-funded FDA,” commented the Alliance for a Stronger FDA.¹

The added $102 million allots $29 million to medical product oversight, $29.5 million to food safety activities, and retains $41 million for cross-cutting initiatives. The legislators direct FDA to use the increase for medical products to better track medical device shortages, tackle the opioid crisis, provide unannounced inspections of foreign drug manufacturers, bolster orphan and rare disease drug development, and support FDA data modernization, field inspections, and minority health programs. The funding committees highlight the importance of conducting real-time, unannounced plant inspections and instruct FDA to spend $5 million on hiring additional foreign-based investigators for this purpose.

More details regarding FDA’s overall funding picture are provided in the report from the House Appropriations Agriculture subcommittee.² Of the $2.8 billion to be collected in user fees, $1.2 billion comes from fees on drugs and biologics, $540 million from generic drugs, and $40 million from biosimilars. The budget plan calls for FDA to do more to regulate cannabis-derived products, advance strategies to combat the opioid crisis, develop a comprehensive food traceability system, and take steps to protect against adulterated dietary supplements.

In the broader health and medicine arena, the funding legislation increases support for the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and other agencies in the Department of Health and Human Services (HHS).³ Of note, Congress provides $1 billion to establish the Advanced Research Projects Agency for Health (ARPA-H) as part of NIH. The amount is way less than the $6.5 billion initially sought by the Biden administration for this new entity, but an important first step in moving it forward.

More controversial is the Democrats’ decision to approve the broad spending package without including President Biden’s $30 billion request for additional COVID-19 relief funds. That amount had already been reduced to $15.6 billion to purchase and continue research on more anti-COVID vaccines, therapies and test kits, but the provision was dropped due to dissension among Democrats over the proposed cuts. Budget increases at CDC, NIH, and the Biomedical Advanced Research and Development Authority (BARDA) are expected to support further R&D in this area, pending future agreement on COVID research activities, but researchers fear significant reductions in these programs.

At the same time, the broader budget bill provides support for a host of specific initiatives, such as a measure limiting access to flavored vaping products by clarifying FDA authority to regulate these products. There are provisions to prevent domestic violence and billions to support thousands of pet projects favored from individual legislators.

User fees next?

Resolution of this federal spending bill clears the way for Congress to start considering legislation to reauthorize a packet of FDA user fee programs by Sept. 30. That deadline opens the door for the legislators to include multiple proposals affecting FDA and biomedical research in the fee package, as seen in a long list of bills already being considered by the House Energy and Commerce Health subcommittee.

The proposals include the Cures 2.0 Act (HR 6000) to advance a range of biomedical research programs plus multiple measures that fall under the heading of “encouraging innovation and improving oversight.” There are bills to overhaul FDA’s accelerated approval process, encourage drug production in the US, advance diversity in clinical trials, support development of certain orphan drugs and rare disease treatments, and ensure access to affordable.⁴ The House panel will begin the evaluation process for these and other proposals at a hearing on Thursday.

References

1. https://mailchi.mp/9483ac927b8a/alliance-friday-update-4844273?e=53e39bce94
2. https://docs.house.gov/billsthisweek/20220307/BILLS-117RCP35-JES-DIVISION-A.pdf
3. https://appropriations.house.gov/sites/democrats.appropriations.house.gov/files/BILLS-117RCP35-JES-DIVISION-H.pdf
4. https://energycommerce.house.gov/committee-activity/hearings/hearing-on-the-future-of-medicine-legislation-to-encourage-innovation