Senate HELP advances PAHPA reauthorization bill
The Senate Health, Energy, Labor, and Pensions (HELP) committee has advanced a pandemic reauthorization bill that would give the US Food and Drug Administration (FDA) greater authority to require manufacturers to notify them of potential product shortages outside the scope of a public health emergency (PHE).On 20 July, the HELP committee voted 17-3 to report the Pandemic and All-Hazards Preparedness Act as amended to the full Senate for consideration. Besides reauthorizing federal authorities to respond to pandemics and other emergencies, the latest iteration of the bill includes new authorities that would enable FDA to require notifications from drugmakers ahead of product shortages, gather additional supply chain information about active pharmaceutical ingredients and would task the Secretary of Health and Human Services with reporting on the implementation of these new shortage authorities. Additionally, the bill would reauthorize FDA’s medical countermeasure priority review voucher (PRV) program until 2028.
Under the bill, manufacturers, including those who produce over-the-counter drugs, would need to notify FDA within 10 business days of a potential shortage if circumstances, such as an increase in demand or export restrictions, would likely cause a shortfall in supply or a meaningful delay in the supply of a drug.
FDA has sought additional authorities on shortage reporting, and it currently has the authority to request information on potential product shortages within the context of a PHE. (RELATED: Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs, Regulatory Focus 23 March 2023)
The House Energy and Commerce (E&C) Committee advanced a similar bill last week that does not include new FDA shortage-related authorities.
The Senate version of PAHPA also includes language that requires additional coordination between HHS and state health authorities and extends a state medical stockpiles pilot program through fiscal year 2028.
Several amendments were offered during the executive session, but most were either withdrawn or were voted down on party lines.
One amendment that did pass was Sen. John Hickenlooper’s (D-CO) proposal to create a team within FDA’s Center for Biologics Evaluation and Research (CBER) that would be tasked with various activities to support the development and authorization of countermeasures to emerging pathogens, as well conduct surveillance of such countermeasures and activities to ensure the safety and availability of the nation’s blood supply.
"This new team would allow FDA to dedicate the necessary manpower to quickly evaluate, and what we can only hope, develop many countermeasures that will come before them during a pandemic," said Hickenlooper.
While Sanders supported the idea, Ranking Member Bill Cassidy (R-LA) argued that FDA’s Office of Counterterrorism and Emerging Threats (OCET) already works on countermeasure-related issues and didn’t see the point of having another office under the Center for Biologics Evaluation and Research (CBER) doing the same job.
The Hickenlooper amendment passed with all Democrats on the committee voting for the measure and all Republicans opposing it.
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