Drug Shortage Is an ‘Urgent Crisis,’ Says ASCO Member Testifying to Congress

Westin noted the effects of the shortage of one specific drug in the brief: fludarabine (Fludara). The chemotherapy agent, which was initially approved over 30 years ago and is currently used in several cancer types, is a necessary part of treatment with CAR T-cell therapies. Although it is a cheap and generic drug, it is a crucial part of CAR T-cell regimens with no known effective substitutes. Due to the financial burdens of CAR T-cell therapy, this treatment type can typically only be tried once. Patients who receive this type of care are often under a time constraint, which makes waiting for the drug nearly impossible, according to Westin.

Jason Westin, MD, MS, FACP, volunteer leader and member of the American Society for Clinical Oncology (ASCO) , testified before the Senate Finance Committee on December 5, 2023, regarding the nationwide cancer drug shortage, according to a press release by ASCO.¹

In his testimony, Westin provided potential solutions that Congress could implement to address this issue.2 First, he advised that alternative payment methods should be created to provide economic relief to manufacturers. Additionally, he indicated that incentivizing purchasers to favor manufacturers with steady supplies, addressing manufacturers risk management issues through enforcement mechanisms, and promoting advanced technology for the continuous manufacturing of cancer drugs should allow for a more reliable stream of production.

Westin, professor of medicine and director of lymphoma clinical research and section chief at the University of Texas, MD Anderson Cancer Center, also detailed his first-hand experience as a clinician delivering cancer care with a shortage of life-saving drugs; this includes more than 15 cancer drugs currently on the FDA’s drug shortage list . Several of the drugs in question are used to treat lymphoma and leukemia, 2 cancers that often affect children and young adults.

“It’s not a situation where we don’t know how to treat your cancer, it’s that we can’t get the drug because it’s not being made,” Westin said in his written statement to Congress.² “We have drugs that are lifesaving and shortages that are life threatening. The shortage of critical cancer drugs is an urgent crisis. My patients, and their families, deserve to know that they will get the care they need without delay. Providers shouldn’t have to make impossible choices about patient care.”

Westin noted the effects of the shortage of one specific drug in the brief: fludarabine (Fludara). The chemotherapy agent, which was initially approved over 30 years ago and is currently used in several cancer types, is a necessary part of treatment with CAR T-cell therapies. Although it is a cheap and generic drug, it is a crucial part of CAR T-cell regimens with no known effective substitutes. Due to the financial burdens of CAR T-cell therapy, this treatment type can typically only be tried once. Patients who receive this type of care are often under a time constraint, which makes waiting for the drug nearly impossible, according to Westin.

“In other words, the absence of a generic and cheap drug like fludarabine can mean the difference between life and death,” Westin emphasized.

He also pointed to the manufacturing quality issues and economic factors that companies face to produce these drugs. Most of the drugs on the shortage list sell from $1 to $8 per dose, which causes slim or even negative profit margins for the few manufacturers who produce these. In addition, because of the lack of economic incentive, quality issues cause a halt in production of these drugs for weeks or months. Oftentimes, if companies are unable to produce product for many months or have to do so with significant expenses, they might choose to pivot to producing more profitable drugs.

Other challenges that are affecting production are the current drug payment policies in which purchasers have no access to information on the quality or supply of the drugs. This leads to no prioritization of cost-cutting over quality improvements or capital investment. In addition, the current Medicare payment system in place makes it so that manufacturers of drugs receive average sales prices (ASP) plus 6%. However, these numbers are based on previous quarters. New manufacturers are disincentivized from increasing production and correcting quality issues due to the artificially low rates of sales due to delays in updating the ASP.

References

1. ASCO Member Testifies to Congress About the Cancer Drug Shortage Crisis. Association for Clinical Oncology. News release. ASCO December 5, 2023. Accessed December 5, 2023.
2. Testimony of Jason R. Westin, MD, MS, FACP. Association for Clinical Oncology. December 5, 2023. Accessed December 5, 2023. https://bit.ly/46UUUdS