Pallone Calls on E&C Republican Leaders to Address National Drug Shortage Crisis as Part of PAHPA Reauthorization

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) released the following statement today calling on House Republicans to take action to address the national drug shortage crisis as Congress reauthorizes the Pandemic and All-Hazards Prevention Act (PAHPA) this year:

"Every day there are new reports of the impact the national drug shortage crisis and other supply chain issues are having on Americans. There are heartbreaking stories of cancer patients who have had their chemotherapy appointments canceled due to shortages, parents who can't find children's aspirin on store shelves, and millions of Americans struggling to fill prescriptions to treat ADHD. And these are just a few examples of the shortages around the nation.

"These concurrent shortages have resulted in the worst national drug shortage crisis in recent memory. We also know that pandemics and other public health threats would be made far worse if we do not have a resilient supply chain that can support treatment and readiness. Congress has a clear obligation to act to provide the Food and Drug Administration with the tools and resources it needs to help bring these shortages to an end.

"I'm extremely disappointed that Committee Republicans' have refused to act on drug shortages so far. This is a clear and present emergency that demands action and PAHPA is the natural place to do it.

"Republican Committee leaders' assertions that PAHPA shouldn't include FDA-related policy do not make sense and defy reality considering all previous PAHPAs have included FDA policy. The initial PAHPA included a provision requiring FDA to prepare for shortage issues that might arise, and all previous reauthorizations have included FDA-related policy.

"There is no justifiable reason that this year's reauthorization shouldn't help us use the tools and regulatory expertise of the FDA, especially considering we're in the middle of national shortages impacting millions of Americans.

"This is a crisis that demands urgent government action, not excuses and procedural stall tactics. The American people need help, and it is time for Committee Republican leaders to do something about it."

PAHPA and all previous reauthorizations of the law have included FDA-related in policy.

In 2006, the initial PAHPA required FDA to establish a team of experts to provide technical assistance to manufacturers of vaccines and medical countermeasures (MCMs) to help prevent or alleviate drug shortages.

In 2013, the Pandemic and All-Hazards Preparedness Reauthorization Act expanded FDA's authorities to issue emergency use authorizations (EUAs), provided FDA with the authority to extend the expiration date of MCMs, the authority to permit emergency dispensing of drugs, and issue emergency use instructions.

In 2019, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act supported FDA's efforts related to the development and availability of MCMs. This included increasing the availability of MCM regulatory management plans and the use of MCM master files, maintaining an adequate and safe national blood supply, and requiring a strategy for cybersecurity threats. The 2019 reauthorization also formalized FDA's role and responsibility in the preparedness enterprise by including FDA in the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).

Energy and Commerce Committee Democrats are supporting five bills that would address drug and medical device supply chain issues to help ensure we are prepared for future public health emergencies while providing tools to mitigate ongoing shortages now. Unfortunately, the Committee Republicans have so far declined to take up the bills as the Committee begins the process of reauthorizing PAHPA.