ICYMI: Oncologist Urges Congress to Act on Drug Shortages at June E&C Health Subcommittee Hearing

Last month, the Energy and Commerce Committee's Health Subcommittee held a hearing on "Legislative Solutions to Bolster Preparedness and Response for All Hazards and Public Health Security Threats."

At the hearing, Dr. Julie Gralow, Chief Medical Officer and Executive Vice President of the American Society of Clinical Oncology (ASCO), discussed the dire situation the national drug shortage crisis has put cancer patients in and urged Congress to act.

Committee Democrats have put forward legislative proposals to address the shortage crisis and repeatedly called on House Republican leaders to consider them as Congress reauthorizes the Pandemic and All-Hazards Preparedness Act (PAHPA) this year. Unfortunately, House Republican leaders continue to refuse to address the national drug shortage crisis as patients across the nation experience the devastating effects of the shortages.

Dr. Gralow's remarks, as delivered, before the Health Subcommittee last month are below:

"Prior to joining ASCO, I was a practicing medical oncologist and professor in Washington State for three decades. ASCO represents over 45,000 oncology professionals who are dedicated to improving cancer care. We appreciate the subcommittee's efforts to improve the programs in PAHPA to better prepare the U.S. for future public health crises.

"The pandemic exacerbated longstanding issues that threaten the resilience of our healthcare supply chain. While the Strategic National Stockpile and other programs authorized under PAHPA aided the health care community during the public health emergency, more must be done.

"Drug shortages will worsen without intervention. This is especially true for sterile injectables, many of which are oncology drugs. These drugs are expensive to make, they have a low profit margin, and they lead manufacturers to reduce or discontinue production.

"Active pharmaceutical ingredient sourcing is a weak point. Many manufacturers use the same API source. If that source experiences quality issues causing a production [shut] down or runs out of critical components, drug shortages are a likely outcome.

"Visibility into the supply chain regarding APIs is lacking. The FDA does not have authority to require manufacturers to provide API sourcing information. This means shortages can emerge without warning. Today's shortages are the worst that I've seen in my 30-year career.

"I'm in regular communication with colleagues at the University of Washington and Fred Hutchinson Cancer Research Center in Seattle. Initially, they were optimistic that with dose modifications and substitutions, they had enough supply of these platinum agents to ride the shortage out.

"Then, however, many of the state's smaller cancer centers began running out of drug and sending their patients to the UW, depleting their supply. I spoke to a patient diagnosed with endometrial cancer whose team recommended a chemotherapy course that included a platinum agent. She studied the drugs and their side effects. She had a game plan, and she did well through her first cycle of treatment, much to her relief.

"Then, when arriving for her second dose, one of the agents was no longer available. You can imagine the anxiety this caused. Even when there are acceptable and proven alternatives, switching a planned course of treatment adds fear and stress to that already caused by a cancer diagnosis.

"Eleven oncology drugs, maybe 14, are currently in shortage. Four of these, cisplatin, carboplatin, methotrexate, and fludarabine, are commonly used to treat cancer in adults and children.

"In 2022, 100,000 Americans were diagnosed with ovarian, bladder, and testicular cancers, cancers for which cisplatin and carboplatin are recommended. These drugs are also commonly used in cervical, endometrial, lung, head and neck, esophageal, gastric, and breast cancers. The number of US patients at risk could be as high as 500,000 a year.

"Drug shortage risks also extend to pediatric patients. From 2010 to 2020, eight of the 10 most frequently used drugs to treat acute lymphoblastic leukemia, the most common childhood cancer, were at some point unavailable.

"Beyond drugs, we've experienced essential supply shortages, including glass vials, IV tubing, saline bags, and more. Shortages place providers in a moral dilemma, prioritizing drug use for patients who are curable versus those who are not. Patients worry about whether they'll receive their next treatment or if switching to another treatment will shorten their lives.

"The PAHPA reauthorization is opportunity to advance solutions to improve the supply chain, especially during public health crises.

"ASCO makes the following recommendations detailed in my written statement. Improve the function and composition of the national strategic stockpile. Enhance multinational collaboration on supply chain resilience. Incentivize manufacturers to improve quality and transparency. Reduce reliance on other countries for critical ingredients. Analyze domestic drug and device manufacturing capability and capacity for critical products to avert national security threats.

"I appreciate the subcommittee's efforts to enhance the supply chain to protect our national security and our patients' health. ASCO stands ready to collaborate with you to ensure individuals with cancer receive the life-saving and life-prolonging treatments they require.

"This is a crisis. Cancer patients' lives are on the line. Thank you."

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