As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global economies. The agency’s reach continues to expand with the proliferation of outsourced and offshore manufacturing, clinical trials and global supply chains. The past year was notable for FDA’s continued efforts to align and scale its regulatory processes to keep pace with growing innovation in drug and device development and food production, and the rise and market dominance of in vitro diagnostics (IVDs), including laboratory-developed tests (LDTs), in the wake of the COVID-19 pandemic. Congress’s failure to enact the long-awaited and hotly contested Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would have expanded FDA’s authority over LDTs, increases the likelihood that VALID will be on the legislative agenda in 2023. The drive toward modernization has also prompted a reexamination of established regulatory programs such as expedited review pathways for drugs and devices. As the number and corresponding financial import of breakthrough designations increase, the agency is under greater pressure to assess whether these programs have fulfilled their original goals of improving patient outcomes in areas of unmet need and clearing the path for innovative products.
FDA continues to tussle with industry and courts regarding the scope of its discretion to interpret decades-old statutory provisions. As it has in the past, the agency seeks to expand the bounds of its interpretative authority, and courts continue to chip away at the degree of deference afforded to the agency. In the areas of drug and device regulation and digital health (i.e., the Software Pre-Certification Pilot Program), FDA has conceded the need for affirmative legislative authority and congressional intervention to respond to judicial pushback and regulatory complexities inherent in its responses to innovation. While FDA’s various user-fee-related bills were for the most part passed without any revisions to the Federal Food, Drug, and Cosmetic Act (FDCA), legislative intervention came in the form of the Consolidated Appropriations Act, 2023 (2023 Omnibus), which contained the Food and Drug Omnibus Reform Act (FDORA), signed by President Biden on December 29, 2022. The 2023 Omnibus enacted a subset of the provisions contemplated in various user fee acts that enhance FDA’s authority to address public health emergencies (PHEs), protect the drug supply chain, impose stricter cybersecurity requirements on medical devices and support greater access to generic drugs.
While enforcement declined in 2022, the steady march toward normalization of factory inspections and post-market surveillance activities may signal an increase in enforcement as FDA and the world emerges from the global pandemic. The finalization of key guidance documents for clinical decision support (CDS) and food labeling may also signal increased scrutiny in those sectors in 2023.
The FDA regulatory environment will be as complex and dynamic as ever in 2023. FDA will continue to implement new policies, reexamine old programs and normalize processes to encourage greater engagement with industry-significant policy issues. It remains to be seen how much the agency will accomplish and what it will prioritize before the start of the 2024 presidential election cycle, where healthcare will undoubtedly drive the agenda in a post-pandemic environment.
McDermott Will & Emery staff attorney, Christine Dower, also contributed to this report.