FDA seeks 10% boost in Biden’s FY 2024 budget

The US Food and Drug Administration’s (FDA) is seeking to increase its budget authority by 10% in fiscal year 2024 as part of the Biden administration’s $6.9 trillion budget request. While the budget request also includes multiple legislative asks from the agency, it does not address diagnostics reform.
 
In total, FDA is requesting $7.2 billion in funding, which includes $3.9 billion in appropriated funding and $3.3 billion in user fee funding. Overall, the agency is asking for $372 million more in budget authority and $150 million more from user fees compared to FY 2023.
 
Besides increasing FDA funds for the next fiscal year, the administration has included several legislative requests, such as giving FDA the authority to require medical device manufacturers to notify it of product shortages outside the scope of a public health emergency (PHE).
 
“Medical device shortages occur in many situations that fall outside of or are unrelated to PHEs, including natural or human-made disasters, recalls, geopolitical conflicts, production shutdowns and cybersecurity incidents,” FDA said. “These events can lead to device shortages that significantly impact patient care and jeopardize healthcare worker safety. Therefore, FDA is seeking the requirement for manufacture notifications at all times, as well as the authority to require and review risk management plans to help ensure that manufacturers are prepared for situations where their ability to manufacture product may be disrupted or may be insufficient to meet demand.”
 
FDA also is asking for $11.6 million for medical device supply chain enhancements and shortage programs.
 
“The budget will allow the FDA to expand efforts to work proactively with medical device companies, health care providers, device distributors, and patients to enhance resiliency in the supply chain of critical medical devices and prevent shortages of critical devices that most often impact vulnerable populations,” the agency said.
 
Similarly, FDA wants to expand its drug shortage reporting requirements to include situations where manufacturers are unlikely to meet increased demand. The agency said this ability would allow it to help prevent or mitigate drug shortages.
 
FDA also wants to expand its mandatory recall authority to cover all human and animal drugs. The agency currently only has authority to implement such recalls for controlled substances, biological products, medical devices, tobacco products, cosmetics and foods.
 
The budget request notably did not address diagnostics reform. After the Verifying Accurate Leading-edge IVCT Development (VALID) Act failed to become law in the last Congress, FDA Commissioner Robert Califf has said the agency could pursue diagnostics reform through rulemaking. (RELATED: Califf: FDA may use rulemaking for diagnostics reform if VALID isn't passed, Regulatory Focus, 25 October 2022)
 
During a press conference at the Department of Health and Human Services (HHS) headquarters, Califf declined to comment on why diagnostic reform did not make the cut for legislative asks in the budget.
 
FDA spokesman Michael Felberbaum however told Focus after the press conference it’s still an issue the agency is working on.
 
“Diagnostic testing remains a priority that we'll continue to work on with the Administration and Congress,” he said.
 
One of Biden’s signature projects as vice president was the Cancer Moonshot to develop new cancer treatments, which he launched in 2016 after his son Beau Biden died of brain cancer. As president, Biden has renewed his support for the program and is asking for $1 billion to support the initiative across several federal agencies, including $50 million that would go to FDA.
 
“This funding will advance the President’s Cancer Moonshot, including by expanding resources and collaborations for innovative and new diagnostic and therapeutic products to treat rare cancers, and other efforts to address cancer morbidity and mortality,” said FDA. “This budget will enhance efforts to improve evidence generation for underrepresented subgroups in oncology clinical trials, and to support pragmatic and decentralized trials and our sources of evidence through patient-generated data, learnings, and real-world evidence.”
 
“Additionally, these resources will also assist the FDA’s expansion of its efforts to facilitate the approvals of innovative and new cancer treatments by international regulatory authorities at the time of the FDA’s approval and will foster collaboration of cancer treatments in other countries with standards comparable to the U.S. standard of care,” the agency added.
 
FDA is asking for $10 million for its IT modernization plans which have been a key focus for the agency over the past few years. It is also asking for $16 million for crosscutting measures it plans to take in the Office of the Commissioner, though the agency has not offered additional details on what those measures would be. The agency also wants $9.4 million to maintain and update its facilities and infrastructure.
 
In addition to funding for medical products, the president’s budget also includes a request for $128.2 million for food safety and modernization, including to help pay for projects that address food labeling and animal food safety oversight.
 
In the wake of the infant formula scandal and shortage over the past year, several top lawmakers have called on FDA to reform its food regulatory oversight. In response, FDA recently proposed appointing a deputy commissioner for human foods who reports directly to FDA commissioner and put together a larger executive team to manage the food program. It has also proposed restructuring the Office of Regulatory Affairs (ORA) to reform its food safety oversight program, which the agency said will make the office more efficient. (RELATED: FDA proposes streamlining inspections office along with new human foods center, Regulatory Focus 31 January 2023)
 
While the budget calls for additional resources for its food program, Califf said the resources are not meant for restructuring.
 
“This current budget does not include money for the restructuring,” Califf said during the HHS press conference. “It does include additional money for the human foods program based on needs that were already identified, for example, infant formula, where there’s a lot of work to be done in building that program.”
 
“The plan for the future is, as we’re restricting the human foods program, once we get the house in order and things organized and activities tied directly to the budget, then we’ll be coming back where needs are identified and raising those as budgetary issues,” he added.
 
FDA is also seeking $5 million to modernize its cosmetics oversight program, $23 million additional funds to fight the opioid crisis, and $2.5 million to help develop treatments for amyotrophic lateral sclerosis (ALS) disease.