On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (H.R. 2617), an omnibus appropriations bill to fund the U.S. government for fiscal year 2023. This 4,000-plus-page bill also contains important reforms relevant to the Food and Drug Administration ("FDA"), including the Food and Drug Omnibus Reform Act of 2022 ("FDORA") and the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (the "PREVENT Pandemics Act").
FDORA (pronounced, as we understand it, like the headwear most famously donned by Indiana Jones), in particular, is home to many provisions that were originally expected to be enacted earlier this year as part of FDA's user fee reauthorization process. Although Congress had historically used the user fee reauthorization legislation as a vehicle for attaching various FDA-related policy riders and amendments to the Federal Food, Drug, and Cosmetic Act (the "FDCA"), Congress was unable to reach agreement on such riders this year. This resulted in the September 2022 passage of a "clean" user fee reauthorization, as Ropes & Gray previously summarized. Many, but not all, of the policy riders left out of the user fee reauthorization legislation are now included in the December 2022 omnibus bill.
Among the most notable provisions within FDORA and the PREVENT Pandemics Act are requirements to encourage clinical trial diversity, reforms to FDA's accelerated approval processes, a long-awaited modernization of the FDA regulatory regime for cosmetics, and enhanced FDA oversight of infant formulas. This Alert summarizes the key provisions that were included in the omnibus bill as well as the provisions that were left out once again.
Key Provisions of FDORA and the PREVENT Pandemics Act
Key reforms to FDA's authority and matters within FDA's jurisdiction include:
Reforms Relevant to Medical Products Generally
- Clinical Trial Diversity. Several FDORA provisions encourage changes that will lead to greater diversity in the populations participating in clinical studies. Sponsors are now required to submit to FDA "diversity action plans" for certain late-stage trials for drugs and devices, unless otherwise waived or excepted. FDA is tasked with updating guidance on diversity action plans for clinical studies and hosting public stakeholder workshops focused on enhancing clinical study diversity. Additionally, within one year, the agency is to, as applicable, issue or revise guidances on the appropriate use of decentralized clinical studies in the development of drugs and devices, how digital health technologies can be best used in clinical trials, and how seamless, concurrent, and other innovative clinical trial designs can support expedited drug application development and review. Ropes & Gray has analyzed these diversity-related reforms and their implications in more detail in a separate Alert.
- Bioresearch Monitoring ("BIMO") Inspections. FDORA clarifies FDA's authority to conduct BIMO inspections by expressly permitting inspection of facilities involved in the preparation, conduct, or analysis of clinical and non-clinical studies submitted to FDA as well as other persons holding study records or involved in the study process. FDA is directed to issue draft guidance on this additional inspection authority within 18 months.
- Pre-Approval Communications with Payors. FDORA features a provision permitting both drug and device manufacturers to share certain information with payors, formulary committees, and similar entities regarding investigational products and investigational uses of approved products. This statutory amendment essentially codifies FDA's policy on pre-approval communications with payors that it had previously issued in a non-binding guidance document in 2018, as Ropes & Gray previously reported.
- Extension of Permitted Health Care Economic Information ("HCEI") Communications to Devices. Since 1997 the FDCA has permitted drug manufacturers to communicate HCEI with payors, formulary committees, and similar entities under certain conditions. FDORA expands the scope of this provision to include devices in addition to drugs. FDORA essentially codifies FDA's position from its 2018 guidance document on payor communications in which FDA stated that its recommendations on HCEI communications were also generally applicable to device companies.
- Clarification for Registration of Foreign Drug and Device Establishments. The PREVENT Pandemics Act clarifies that foreign drug and device manufacturing establishments are subject to...
