REALITY CHECK: PAHPA Has Always Included FDA Policy

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) released the following statement once again urging Republicans to reconsider their refusal to include critical provisions to address the national drug shortage crisis in legislation to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA):

"The Republican Committee leadership is putting American lives at risk with their refusal to address our nation's drug shortage crisis in PAHPA reauthorization. Democrats have put forward commonsense proposals that would improve our ability to quickly identify and respond to future pharmaceutical and medical device shortages.

"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.

"It's time Committee Republicans recognize that drug shortages are a clear and present emergency that demands immediate action and that PAHPA is the natural place to do it."

REALITY CHECK: PAHPA and all previous reauthorizations of the law have included FDA-related 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).

THE NATION'S DRUG SHORTAGE CRISIS: Drug shortages are at a five-year high with the number of drugs in short supply increasing by 30 percent last year alone. Two chemotherapy drugs used to treat a wide variety of cancers are in short supply, causing the worst chemotherapy shortage in decades. Earlier this year, a confluence of increased cases of influenza, RSV, and COVID-19 led to national shortages of children's medications. Millions of Americans are struggling to fill prescriptions for ADHD medications following what appears to be increasing demand for the medications. Pfizer also recently reported an antibiotic shortage that is expected to last well into 2024, part of a nationwide shortage of antibiotics used to treat infections like syphilis, strep throat, and ear infections.

COMMITTEE DEMOCRATS PROPOSE SOLUTIONS: 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.