GILLIBRAND, SCOTT PRESS FDA ON SHORTAGE OF CANCER DRUGS

Washington, D.C. - Today, U.S. Senators Kirsten Gillibrand (D-NY) and Rick Scott (R-FL), ranking member and chairman of the Senate Aging Committee, pressed the Food and Drug Administration (FDA) on what actions it is taking to alleviate the shortage of critical cancer medications.

"We must do everything we can to make sure no cancer patient goes without life-saving chemotherapy drugs," said Senator Gillibrand. "However, addressing this crisis cannot come at the expense of patient safety or a secure supply chain. Senator Scott and I are pressing the FDA to develop a plan to fix the drug shortage while also ensuring that imported drugs are up to American regulatory standards."

"When older Americans are battling cancer, a delay or shortage in treatment availability is a matter of life and death," said Senator Scott. "I'm grateful for President Trump and his administration's work to alleviate the supply strain on critical cancer-fighting medications, and I am committed to partnering with them to put safety and availability first. I am proud to join Ranking Member Gillibrand to ensure our seniors receive the best, on-time, treatment in their fight against this awful disease."

Currently, the United States is experiencing a national shortage of essential generic chemotherapy drugs, including ifosfamide, carboplatin, cisplatin, and oxaliplatin. According to the FDA, the shortages are the result of manufacturing problems, shipping delays, and decisions by some companies to stop producing the medications. If the drug shortage persists, doctors may be forced to ration their patients' medications or even prioritize certain patients over others.

The Department of Health and Human Services (HHS) has reported that FDA is considering temporarily allowing the importation of medications from overseas manufacturers that do not typically supply American markets to help remedy the shortage. To ensure patient safety, Gillibrand and Scott requested a briefing from FDA to answer questions about how these imported drugs will be evaluated for quality, what foreign manufacturers are being considered, and what steps FDA is taking to prepare for future drug shortages.

The full text of the senators' letter to Acting FDA Commissioner Kyle Diamantas can be found here or below:

Dear Acting Commissioner Diamantas,

We write to express concern regarding the escalating national shortage of the critical oncology medications ifosfamide, carboplatin, cisplatin, and oxaliplatin highlighted in recent reporting. The prospect of widespread clinical rationing of frontline chemotherapy presents a crisis for patients, particularly older Americans who disproportionately rely on these medications. Some health systems are already reportedly receiving only a fraction of their standard supply, forcing clinicians to space out doses, prioritize certain patients over others, or ration medications to manage shrinking supplies.

The U.S. Department of Health and Human Services (HHS) has reported that the Food and Drug Administration (FDA) is actively working to alleviate these shortages and is considering temporarily allowing the importation of medications from overseas manufacturers that do not typically supply the United States market. Remedial action of this kind is not novel, as the FDA employed similar strategies in navigating the carboplatin and cisplatin shortage crisis in 2023, but it is essential to ensure the safety and efficacy of any medicine administered to an American patient.

We appreciate the FDA utilizing its regulatory flexibility to inject supply into a strained system, but the temporary introduction of foreign pharmaceuticals raises potential safety concerns that demand transparency. To provide clarity to Congress and ensure patient safety, we respectfully request a briefing from the FDA by September 4, 2026, to answer the following questions:

1. Which specific foreign manufacturers and facilities is the FDA currently evaluating, or has it authorized, for temporary importation of drugs in shortage?

1. In which country are these manufacturers and facilities located?
2. Have any of these manufacturers received a Form 483 or been classified as Official Action Indicated (OAI) or Voluntary Action Indicated (VAI), specifically with respect to the drugs in shortage?

2. What protocols, quality checks, and regulatory standards is the FDA applying to guarantee supplemental imports meet safety standards?

3. How will the FDA monitor imported chemotherapy drugs for contamination or subpotency once they are in the U.S. market?

4. How will shortage staff work with the Office of Inspections and Investigations (OII) and relevant quality staff within the Center for Drug Evaluation and Research (CDER) to ensure that facility inspection history and drug quality are considered in shortage mitigation efforts?

5. Does the FDA anticipate that efforts to temporarily rectify the shortage will result in increased costs for hospital purchasers or individual patients?

6. The 2023 carboplatin and cisplatin shortage prompted conversations about a durable solution for the chemotherapy supply chain. What steps has the FDA taken to prepare for future shortages given the continued fragility of that supply chain?

7. What is the market share for the oncology drugs in shortage? How many FDA-approved alternatives exist for these drugs and what are their respective market shares?

Thank you for your attention to this request and ongoing work to protect patients. We look forward to your prompt response and working together to ensure older Americans maintain access to critical medications.

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