According to a recent American Society of Clinical Oncology (ASCO) press release, Dr. Jason Westin provided testimony regarding a nationwide shortage of cancer drugs, numbering more than 15 on the FDA’s shortage list.
Dr. Westin, a clinical research director at the Texas MD Anderson Center, described his experience working with cancer patients and the shortage of drugs that could save their lives.
The doctor added that several drugs on the FDA shortage list are drugs that treat leukemia and lymphoma, two cancers that frequently affect young adults and children.
In his written statement directed to Congress, Dr. Westin added that he tells patients it is not a question of whether doctors know how to treat the cancer, but it is a question of whether or not they can get the drug. In many cases, the drug is simply not being manufactured.
The doctor went further by reiterating that this shortage of vital cancer drugs is a crisis, and that his patients and their families should be confident that they will get adequate care without further delays. Dr. Westin said that doctors should not be put in a position of making impossible choices.
Potential Solutions
As part of his testimony to Congress, Dr. Westin listed several possible solutions such as:
- Alternative payments to manufacturers that would provide financial relief
- Incentives to purchasers for easing manufacturers’ burdens through steady supplies
- Addressing the risk management issues of manufacturers by enforcement mechanisms
In addition, Dr. Westin suggested that promoting technological advancements would support the continuous manufacturing and production of vital cancer drugs.
As an example, the doctor described circumstances surrounding the shortage of the drug fludarabine that was approved more than 30 years ago. Fludarabine is a generic and inexpensive drug that is used in several types of cancer treatment. Yet it is critical to CAR T therapy, and there are no available substitutes. Patients who rely on this type of therapy usually need immediate care so that waiting for a drug is virtually impossible.
Dr. Westin added additional emphasis by saying that even the shortage of an inexpensive drug such as fludarabine could impact life or death.
About Manufacturing Challenges
Quality issues in manufacturing are closely aligned with economic factors as most of the drugs on the FDA’s list sell per dose between $1 and $8, resulting in sparse or even negative profits.
Therefore, the drug’s production may be halted for months, leading companies to look elsewhere and produce products that are more profitable.
According to Dr. Westin, the current Medicare system provides drug manufacturers with a sales price average plus six percent based on previous quarters. Also, under current policies, purchasers are not privy to information about the supply or quality of the drugs.
These issues do not incentivize new or current manufacturers. Hopefully, addressing some or most of these problems will provide access to these critical anti-cancer medications.