The omnibus spending bill passed by Congress in December 2023 includes funding and direction for the United States Food and Drug Administration (FDA). The FY 2023 spending bill includes a $6.56 billion budget for the FDA, with $3.5 billion coming from appropriations and the rest of which is to be derived from user fees (and therefore credited to the individual user fee account, where it shall remain available until spent). The FY 2023 budget is a 6.5% increase over the FY 2022 budget, equating to about $226 million more in discretionary spending than the FY 2022 budget allowed for.
Funding Specifics
The budget provides targeted increases to address the opioid crisis, medical supply chain issues, cybersecurity of medical devices, and as mentioned in greater detail below, increased in-person inspections of foreign drug manufacturers. It also includes a $41 million increase to: better avoid or more quickly respond to food outbreaks, improve the animal food inspection system, and address heavy metals in baby food. The bill also appropriates $50 million to accelerate medical product development as authorized under the 21st Century Cures Act. An additional $43 million is allocated to medical product safety and $21 million for infrastructure.
One inclusion in the omnibus bill is the ability for the FDA to issue Certificates to Foreign Governments (CFGs) for medical devices that are manufactured by companies based outside of the United States, provided certain requirements are met. Another international impact is the $10 million allocated for the pilot program to expand its unannounced foreign facility inspection program – an attempt to achieve parity with domestic inspections, which tend to be unannounced inspections.
The pilot program is intended to evaluate the differences in the number and type of violations identified during both announced and unannounced surveillance inspections of international drug establishments. The pilot program will also weigh costs and benefits associated with announced versus unannounced inspections of foreign facilities, identify barriers associated with unannounced inspections of foreign sites, and identify challenges associated with achieving parity between domestic and foreign human drug inspections. The omnibus bill requires that the pilot identify approaches for mitigating negative effects of announced international inspections and to launch the program with in 6 months of the bill’s enactment – sometime in June 2023.
Upon completion of the pilot program, within 6months, the FDA is required to publish a report on its website that details the number of unannounced inspections during the pilot program, with its finding and recommendations related to evaluating and addressing barriers to the unannounced foreign inspections, as well as recommendations to achieve parity between domestic and international drug inspections.
Among other things, the omnibus bill also included provisions that will allow the FDA to approve predetermined change control plans that are submitted in premarket applications and supplemental applications, as long as the device would remain safe and effective without any change in approved devices and as long as the device would remain safe and effective without the change and substantially equivalent to the predicate with the change in a predetermined change control plan.
What’s Missing?
However, while the legislation includes several directions that the FDA is to follow, it does not include a diagnostic reform bill that the FDA – and other stakeholders – sought funding for. The Verifying Accurate Leading-edge IVCT Development (VALID) Act would have allowed the agency explicit authority to oversee laboratory-developed tests (LDT). However, detractors of the legislation, including Cathy McMorris Rodgers, fought to keep the legislation out of the omnibus negotiations, as she believes the legislation would put “undue burdens on academic medical centers.”