Pandemic Preparedness Legislation Bolsters FDA Oversight

Senate leaders are developing a broad legislative package to enhance the government’s ability to prevent and respond to future public health emergencies, with an emphasis on securing supply chains, expanding health data collection, and supporting access to vital medical products. A preliminary discussion draft of the PREVENT Pandemic Act was released last week by the Senate Health, Education, Labor & Pensions (HELP) Committee to gain input and support from the multiple parties affected by its provisions.

A main focus of the bi-partisan legislation, jointly issued by committee chair Patty Murray (D-Wash) and ranking member Richard Burr (R-NC), is to clarify responsibilities for the multiple federal agencies involved in health care and national preparedness, including FDA. Lead provisions would enhance the authority of the Centers for Disease Control & Prevention (CDC), while also extending Congressional oversight by requiring Senate confirmation of the CDC director. There are measures that set new research and operational requirements for the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) in the Department of Health and Human Services (HHS). Many of the provisions that apply specifically to FDA are not new, but would clarify and extend existing authorities.

While BARDA would collaborate with NIH and CDC in establishing research centers to advance the discovery and early development of priority medical products and countermeasures, FDA would support such efforts with added guidances and policies for expediting countermeasure development and review. These initiatives would aim to modernize and improve clinical research and further harmonize with foreign regulators by advancing the use of digital technologies, decentralized clinical trial methods, real-world data and evidence, and R&D platform technologies. FDA would report on these programs and on the agency’s ability to hire, recruit and retain needed experts to carry out its many assignments. A noted provision calls for expedited FDA review of new drugs and biologics to treat certain infectious diseases, building on legislation enacted in 2012 that provided an additional five years of market exclusivity to sponsors of new antibiotics and antifungals.

Under the heading of “mitigating shortages,” FDA would ensure the registration and oversight of all foreign establishments that produce drugs or devices marketed in the US, including product components. There’s a proposal to test unannounced FDA inspections of foreign drug facilities, even though that approach has proven impractical and difficult for the agency to carry out. An advanced manufacturing pilot program further bolsters FDA support for novel drug production systems over the next five years.

To enhance the development and availability of medical devices and diagnostics, FDA would gain more explicit authority to crack down on counterfeit products and to require early notification from device makers of anticipated supply shortages. Additional guidance would accelerate the development of in vitro diagnostic tests for health emergency use and clarify FDA’s ability to request records from device manufacturers when needed to conduct remote inspections.

Another initiative to enhance the nation’s ability to quickly detect and respond to emerging pathogens calls on BARDA to fund “warm-base” manufacturing surge capacity able to rapidly develop needed medical countermeasures–facilities that FDA would monitor to ensure they are well-maintained and meet good manufacturing practices standards (GMPs). Several provisions would expand and secure the Strategic National Stockpile (SNS), assess supply chain vulnerabilities, invest in innovative medical countermeasures, and regularly review surge capacity and supply chain flexibility for SNS supplies.

The public release of this broad legislative proposal in January 2022 sets the stage for including some provisions in the delayed 2022 budget bill that faces a Feb. 18 deadline for enactment. The White House also is working with Congress to gain agreement on a pared-down version of the Build Back Better Act, which could advance certain measures for examining the nation’s pandemic response to date and strategies for enhancing preparedness for the future. Such a package could also authorize billion-dollar investments in R&D and production of cutting-edge technology to bolster US production of semiconductors and other high-tech equipment, where supply chain disruptions have stymied domestic manufacturing in vital industries. Provisions more specific to FDA may be included in legislation to reauthorize FDA user fee programs that Congress is slated to consider later this year.