FDA again urges lawmakers for new notification authority, funding to address future pandemics

The US Food and Drug Administration (FDA) again urged lawmakers to give it additional authority and funding to prepare for the next pandemic, focusing on the authority to require product shortage notifications from medtech manufacturers outside of a public health emergency (PHE) and funding to ensure it can respond to the next outbreak.

The House Oversight and Accountability Committee’s Select Subcommittee on the Coronavirus Pandemic met on 14 November to discuss how to mitigate future pandemics. Lawmakers heard from the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and FDA Chief Medical Officer Hilary Marston.

Marston urged Congress to provide additional authority and funding as requested in the agency’s fiscal year 2025 budget request. Specifically, FDA asked for authorities to require manufacturers to notify the agency when there's increased demand for a product, to report sources of active pharmaceutical ingredients (API) and their reliance on them, require labeling to include the original manufacturer and supply chain information, and require medical device manufacturers to notify the agency about product interruptions or discontinuances outside of public health emergencies (PHE).

Since the start of the COVID-19 pandemic, Marston said FDA has prevented or mitigated 586 medical product shortages using its current authorities, but it needs more authority and tools to prevent future shortages.

"We need greater transparency into supply chains to help ensure access to critical medical products," said Marston. She noted that supply chains are mostly affected by a slew of market forces beyond FDA's regulatory scope. She said that generic sterile injectables are most vulnerable to shortages caused by market dynamics, including competition, investment needs, and demand uncertainty.

"These generic sterile injectables, in particular, not everybody can make them, they need to be sterile... they can't be made everywhere, and they require additional upkeep of those [production] lines... [maintaining] additional buffer stocks, all of these things cost money, and unfortunately the profit margins are razor-thin," said Marston. "That is quite clearly beyond the mission of the FDA, but it is something where we are often trying to work on the fallout."

Marston said that currently, companies are required to tell the FDA if a production line goes down and the manufacturer can’t keep up with demand. However, the agency also needs to know when there's a spike in demand that the manufacturer is unable to keep pace with. Furthermore, she said the FDA wants to know about manufacturers' reliance on APIs so they can foresee potential shortages down the road.

Another major area of concern for FDA has been that medtech manufacturers are not required to tell the agency about supply disruptions outside the scope of a PHE. Over the past few years, the agency has lobbied to persuade Congress to change that and give them broad notification authority (RELATED: Califf calls for mandatory reporting of device shortages, Regulatory Focus, 30 September 2024).

Marston noted that during the pandemic, the agency worked closely with manufacturers and researchers to provide guidance on developing new products and minimize the timeline between development, manufacturing scale-up, and regulatory review. However, that has come at the cost of pushing agency staff to their limits.

Marston said FDA must have operational readiness and the ability to have surge capacity.

"During the COVID-19 pandemic we saw FDA staff pulled away from other work to focus on pandemic work for three years leading to backlogs and fatigue," said Marston. "Creating a specialized program to defend against pathogens and other threats would leave the FDA best positioned to respond to future emergencies and focus experienced staff to work quickly on medical countermeasure development.

"Critical investments are also needed to increase FDA's inspectorate workforce capacity to conduct oversight of those products," she added.

Committee hearing

FDA again urges lawmakers for new notification authority, funding to address future pandemics

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