US FDA sees boost in FY23 budget proposal but no diagnostics reform

US lawmakers have negotiated an FY 2023 budget that would increase funding to the US Food and Drug Administration (FDA) by more than $226 million over last year’s budget. While the proposal includes several ancillary measures, it notably does not include a diagnostic reform bill that the agency and other stakeholders sought.
 
Congressional leaders proposed a fiscal year 2023 omnibus spending bill of $1.7 trillion on 20 December that includes $6.6 billion for the FDA; of that, $3.5 billion is appropriated funding while the rest will be collected from user fees from regulated industries. In all, the agency would get $226 million more in discretionary funding as compared to last year’s budget, an increase of more than 6.5%. Almost $43 million is allocated to medical product safety, $41 million for food safety, $121 million for cross-cutting initiatives, and $21 million for infrastructure investments.
 
The bill is expected to be passed by the Senate by Thursday, 22 December, then sent to the House for a vote. It must be signed by President Joe Biden by Friday to prevent a government shutdown.
 
While the bill includes several measures that address issues such as cosmetics and pandemic preparedness, it notably does not include the Verifying Accurate Leading-edge IVCT Development (VALID) Act. The FDA and industry groups have lobbied for the act, which would give the agency explicit authority to oversee laboratory-developed tests (LDT) (RELATED: AdvaMed, ACLA working on 11th hour bid for diagnostics reform in FY23 budget, Regulatory Focus, 15 December 2022).
 
While there was bipartisan support for the diagnostic reform bill, Rep. Cathy McMorris Rodgers, R-WA, incoming chair of the House Energy and Commerce Committee, successfully fought to keep it out of the FY 2023 budget, industry sources told Focus. She has argued that the bill would put undue burdens on academic medical centers.
 
“VALID’s exclusion is very disappointing, especially since there was strong bipartisan support for both the policy and principles of a level playing field, and of ensuring all tests are safe, effective, and work as intended,” Scott Whitaker, President and CEO of industry group AdvaMed, said in an interview with Focus. “The last thing we need is more Theranos-type tests in our health care system.”
 
Two medtech friendly measures are included in the omnibus bill. One would allow FDA to issue Certificates to Foreign Governments for medical devices that are manufactured by companies based outside of the US, as long as they meet certain requirements. Another would allow FDA to approve predetermined change control plans submitted in premarket applications and supplements.
 
Earlier this year, FDA Commissioner Robert Califf said that he would consider using the rulemaking process regarding LDT oversight if Congress did not do so legislatively (RELATED: Califf: FDA may use rulemaking for diagnostics reform if VALID isn't passed, Regulatory Focus, 25 October 2022).
 
The American Clinical Laboratory Association (ACLA), which had worked with lawmakers and stakeholders to modify to the VALID Act, making it more palatable to clinical laboratories, insists that LDT oversight requires legislative authority.
 
“ACLA maintains that clarity and certainty on the regulatory requirements for clinical laboratories is needed and only through legislation to create a diagnostics-specific framework should new regulation of laboratory developed tests move forward,” according to a statement.
 
Omnibus bill
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