As Congress prepares to reauthorize the Pandemic and All-Hazards Prevention Act (PAHPA) this year, the ranking member of the Democrats’ Energy and Commerce Committee, Frank Pallone Jr., D-New Jersey, is calling on House Republicans to tackle the national drug shortage crisis in the U.S.
At issue is Republican committee leaders’ claims that PAHPA shouldn’t include FDA-related oversight, which “[defies] reality considering all previous PAHPAs have included FDA policy,” according to Pallone.
While Energy and Commerce Committee Democrats are supporting five bills that seeking to tackle drug and medical device supply chain hiccups, committee Republicans have so far declined to take up the prospective legislation, Pallone added.
“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,” the congressman said in a release.
He added that Congress has a “clear obligation” to equip the FDA with the tools and resources needed to help bring a spate of drug shortages to a close.
Past PAHPAs have leaned heavily on the U.S. FDA’s authority. In 2006, for instance, the initial PAHPA required the drug regulator to establish a team of experts to provide technical assistance to manufacturers of vaccines and medical countermeasures to help prevent or ease drug shortages.
In 2013, meanwhile, the Pandemic and All-Hazards Preparedness Reauthorization Act expanded the FDA’s purview to issue emergency use authorizations as well as to extend the expiration date of medical countermeasures and permit emergency drug distribution.
Then, in 2019, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act further supported FDA’s efforts related to development and availability of medical countermeasures by increasing the availability of MCM regulatory management plans and MCM master files. The 2019 update to the act also saw FDA lock down an adequate and safe national blood supply and eke out strategy for cybersecurity threats.
Pallone’s call to action comes a few short weeks after a bipartisan effort by Senators Gary Peters, D-Michigan, and Joni Ernst, R-Iowa, to have several government agencies probe weaknesses in the U.S.’ supply chain and develop a plan to reduce its dependence on foreign countries.
The legislation—dubbed the Pharmaceutical Supply Chain Risk Assessment Act—calls for the Department of Homeland Security, the Department of Defense, the Department of Health and Human Services and the White House Office of Pandemic Preparedness and Response Policy to make assessments and plans to address the issue that has been brewing for years.
Currently, the FDA lists more than 200 drugs in short supply on its online drug shortage database. Separately, the American Society of Health-System Pharmacists lists more than 900 shortages of various drugs and doses.
“Every day there are new reports of the impact the national drug shortage crisis and other supply chain issues are having on Americans,” Pallone said in his press briefing. “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.”
Earlier this month, the National Comprehensive Cancer Network Best Practices Committee unveiled results from a May survey of 27 member centers across the U.S., which found that nearly all treatment centers reported shortages of the widely used platinum-based chemotherapies carboplatin and cisplatin.
Meanwhile, a shortage of ADHD medication that started with the popular drug Adderall has continued to intensify, with Takeda’s rival medicine Vyvanse the most recently affected.
That’s to say nothing of shortages of Pfizer’s penicillin offerings, which the drug behemoth recently predicted will bleed into 2024. Pfizer attributed the supply hiccup to a “complex combination” of factors including “significant” demand increases and a rise in syphilis infection rates in the U.S.