Lawmakers disagree on supply chain fixes in pandemic reauthorization bill

House Democrats want to include language in legislation to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) that would give the US Food and Drug Administration (FDA) more authority to require manufacturers to notify them about supply chain issues, but Republicans say the matter is outside the scope of the legislation.

The House Energy and Commerce (E&C) health subcommittee met on 13 June to start negotiations to reauthorize PAHPA. The Republican-led committee looked at amendments to the legislation to return authority to select a director for the Centers for Disease Control and Prevention (CDC) back to the president, extend a pilot program to fund state stockpiles of medical supplies, fund the Biomedical Advanced Research and Development Authority (BARDA) to develop medical countermeasures for viral threats with pandemic potential, and more.

Despite nearly two dozen amendments under consideration, Democrats, including E&C Ranking Member Frank Pallone (D-NJ), said they fail to make any significant new investments in the US’s ability to prepare for future pandemics and ignore the need to strengthen the medical supply chain.

“Throughout the public health emergency, health care providers, states, and emergency responders faced supply shortages of ventilators, [personal protective equipment] PPE, critical medication and testing supplies,” he added. “And now we are seeing shortages of chemotherapy drugs that are threatening the path to recovery for so many patients battling cancer.”

During the pandemic, the US saw an increase in drug and medical device shortages due to increased demand for certain products and global supply chain issues. While FDA has expanded authority to require manufacturers to notify it of potential medical product shortages during a public health emergency (PHE), FDA Commissioner Robert Califf has called on Congress to extend its authorities beyond a PHE. (RELATED: Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs, Regulatory Focus, 23 March 2023)

“When drug shortages happen, FDA can work with sponsors to extend the shelf life of the drugs available in the market to the latest possible date without losing drug quality, effectiveness or safety,” said Pallone. “However, obtaining scientific information from drug sponsors to support an expiration date change can sometimes take weeks or months. This is time patients may not have.”

Health subcommittee Ranking Member Anna Eshoo (D-CA) also voiced disappointment that the discussion did not include legislation to address medical supply chain issues. She argued that the pandemic showed the US medical supply chain is "broken in three devastating ways," which includes shortages of life-saving supplies, subpar manufacturing and overreliance on foreign production.

Eshoo reminded lawmakers that Califf told them FDA does not have information it needs to identify the sources of active pharmaceutical ingredients (APIs) and that the agency needs to be able to use data from drug manufacturers to safely extend the shelf life of drugs that may be at risk of shortage. She also advocated for giving the agency the authority to require a mandatory recall of drugs that may be contaminated and creating a buffer stop for oncology drugs that are often in short supply due to quality problems.

Eshoo has proposed adding the Drug Origin Transparency Act to PAHPA to help address FDA’s drug supply chain knowledge gap. She also supported giving the agency similar authority to require medical device companies notify regulators about medical device supply interruptions and drug-makers notify it of unintended spikes in demand for drugs.

"One critical area where our country is unprepared is our medical supply chain," said Eshoo. "It's in the DNA of PAHPA to address gaps in supply."

"I'm really begging you to really find a bipartisan path forward, that's really how important these issues are," she added.

Committee Chair Cathy McMorris Rodgers (R-WA) said she agrees supply chain challenges are important but doesn’t think PAHPA is the right vehicle for that discussion.

"I understand that some of my Democratic colleagues are upset that we are not considering legislation related to drug shortages and larger supply chain issues," said McMorris Rodgers. “I will say to them, I welcome that discussion... [but] finding solutions for drug shortages are broader than this reauthorization and FDA, and outside the scope of this preparedness reauthorization."

McMorris Rodgers added that she is also concerned about supply chain issues for critical drugs, such as those to treat cancer, and she recently published a public request for information with Sen. Mike Crapo (R-ID) to solicit information and ideas on the underlying economic causes of drug shortages and the role federal programs may play in causing shortages.

Lawmakers disagree on supply chain fixes in pandemic reauthorization bill

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