The FDA wants more money from Congress for the coming fiscal year — and more power, too.
Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory Affairs (ORA).
The request includes $452 million that would come from Congress— up nearly $44 million from FY 2021 — and $224.5 million from user fees, a $4.9 million increase.
The agency also asks Congress for the authority to require more accurate supply chain information, address shortages of medical devices, enhance the use of records in advance or in place of inspections, expand information-sharing with the states, and extend enforcement authority and penalties for counterfeit devices.
The 421-page budget request includes specific asks for:
- A new Resilient Supply Chain and Shortages Program (+ $21.6 million), a permanent program to boost U.S. medical device supply chain resilience and reduce dependence on other nations — a situation that caused problems during the COVID-19 pandemic.
- Agency-wide support for food and medical product safety (+ $170.8 million), including money for data modernization, inspections, pay increases, funding for the Office of Minority Health and Health Equity, laboratory safety and cybersecurity.
- Digital transformation at CDRH (+ $2.8 million) to integrate, redesign and streamline at least 80% of its core business processes. The effort would help the agency more quickly identify and address safety issues, streamline workflows, reduce the cost of maintaining data and network security, speed the delivery of services and save the medtech industry time and money.
- Ending the opioid crisis (+$2 million) for the development, evaluation, and market authorization of digital medical devices that help address opioid addiction.
The supply chain program would include regulations and partnerships with industry and healthcare providers, predictive modeling, early shortage detection and continuous surveillance of the medtech supply chain and investments in preventive measures to avert shortages before they occur, according to the budget proposal.
“Funding for a permanent device shortages program at FDA is critical to support resiliency in the medical device supply chain for devices to decrease or eliminate the risk of medical device supply chain shortages,” the agency said.
The FDA said it wants the increase in user fees to hire more clinical and scientific experts to evaluate premarket submissions.
“The net benefit for patients from the increase in user fee funds is access, as soon as is appropriate, to innovative devices that are also high-quality, safe and effective, which can improve, extend, and in many cases, save their lives while maintaining FDA’s regulatory standards and reliance on robust science,” the agency said.
