Today, the U.S. House of Representatives Energy and Commerce Subcommittee on Health held a hearing examining the drug shortage crisis and invited ASCO to testify. Charles Penley, MD, incoming chair of ASCO’s Government Relations Committee, past chair of the Clinical Practice Committee, and member of the Conquer Cancer Foundation’s Board of Directors, testified before the Subcommittee on how oncology drug shortages are impacting his practice, as well as the Society’s perceived causes of the shortages and potential solutions.
Dr. Penley told the Subcommittee, “The most difficult thing in the world is to sit across from a patient who has the potential for a cure and tell them we do not have the necessary therapeutic agents. Oncologists and their patients face incredibly difficult decisions on a daily basis.”
Oncology care has been severely impacted as shortages include many generic off-patent, curative chemotherapy treatments that have been standards of care decades. These mainstay therapies have been shown to improve survival, and without them, oncologists are faced with the option of delivering suboptimal care.
Dr. Penley, whose practice is based in Nashville, Tennessee, discussed how the shortages were impacting individual patients, including a Nashville firefighter with advanced gastrointestinal cancer who experienced a shortage of 5-FU based combination chemotherapy.
“5-FU is a commonly used and effective drug, one that has been in the chemotherapy arsenal for many years,” said Dr. Penley. “Earlier this summer our practice was unable to obtain 5-FU, and we were forced to change to another chemotherapy regimen. My patient has endured increased out-of-pocket costs and additional side effects as a result of this alternative treatment.”
Dr. Penley stated that there is no single solution that will address the shortages, but outlined several strategies that, used in concert, could begin to make a difference. The proposed ideas include:
- Removing administrative barriers to encourage manufacturers to enter or remain in the generic market
- Altering the methodology used by Medicare to update payment levels for generic drugs
- Giving the Food and Drug Administration increased authority to manage shortages
- Creating tax incentives to encourage manufacturers to produce generic drugs
- Establishing a national stockpile program similar to that used to counter terrorism
“We must do everything in our power to resolve this crisis, and we should do it immediately,” said Dr. Penley.
The testimony also highlighted what ASCO perceives to be the causes of the shortages. The causes include raw material shortages, manufacturing stoppages due to product quality issues, product discontinuations and market shifts. Dr. Penley also discussed how economic constraints have caused distributors and practices to institute “just in time” inventory models allowing for less product to remain in stock resulting in a more immediate effect when a drug is in short supply.
Howard Koh, MD, the assistant secretary of health for the Department of Health and Human Services, testified that the more than 300 trials funded by the National Cancer Institute include a cancer drug in short supply.
"The inability to obtain adequate supplies of these cancer drugs for research has resulted in promising clinical trials being suspended indefinitely and patient enrollment being abruptly halted," Koh said.
Charles Penley, MD, Chair-Elect of ASCO's Government Relations Committee,
testifies before Congress on the nation's drug shortage crisis.
testifies before Congress on the nation's drug shortage crisis.
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