Biden seeks $2.1B funding boost for FDA, part of pan-agency pandemic preparedness plan

The Biden administration has proposed a $2.1 billion boost in funding for the FDA in 2023 to support the Cancer Moonshot program and pandemic preparedness. In total, the FDA could be up for $8.39 billion, a 34% increase over the $6.25 billion enacted for 2022. 

Elsewhere, the White House requested $5 billion for Biden’s Advanced Research Projects Agency for Health, or ARPA‑H, initiative.

“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities,” said Commissioner Robert Califf, M.D., who took the role just over a month ago.

New this year will be $1.63 billion for pandemic preparedness as a mandatory budget request—just a fraction of the total $81.7 billion ask the White House is making for this mission across the agencies that fall underneath Health and Human Services.

NIH ARPA-H chart

The FDA touted its response to the pandemic in the budget request, specifically the successful authorization and approval of several COVID-19 vaccines and treatments including Pfizer-BioNTech's Comirnaty. The agency will direct the funds toward expanding and modernizing its regulatory capacity, information technology and laboratory infrastructure to be able to quickly respond to a future pandemic or high consequence biological threat.

Funds will be directed toward strengthening personal protective equipment supply chains, which was a complicated issue to sort out at the beginning of the pandemic. The FDA will also work to speed development of diagnostics for future viral pathogens. Finally, the money will help strengthen foreign inspections, reviews of vaccines, therapies and diagnostics and more.

To reignite the Cancer Moonshot program, the FDA budget request includes an additional $20 million in one-time funding for the FDA's Oncology Center of Excellence programs for patient voice, real-world evidence and ensuring fast patient access to new cancer therapies. The goal of the Moonshot program is to reduce the cancer death rate by at least 50% over the next 25 years by diagnosing the disease earlier and researching new treatments for the deadliest and rarest cancers.

ARPA‑H will get a big boost if the request goes through. While $1 billion was earmarked for the science program for this year, the White House wants $4 billion more for 2023 to support biomedical innovation and new technologies.

Other requests include $6 million to address cybersecurity vulnerabilities for medical devices, $54 million to support capacity-building efforts at the agency, $34 million for pay raises and $68 million for technology and data modernization efforts.