As cancer drug shortages persist, ASCO official urges congressional action at hearing

A year into a dire shortage of essential cancer medicines in the U.S., the American Society of Clinical Oncologists (ASCO) is again pushing Congress to act to end the crisis.

In prepared testimony for a recent House committee hearing on drug shortages, ASCO’s chief medical officer, Julie Gralow, M.D., pushed for action in the areas of payment, manufacturing and more.

For one suggestion, Gralow recommended congressional consideration of alternative payment methods to relieve “artificially low” reimbursement rates on generic meds.

The status quo creates “adverse market incentives” for manufacturers to prioritize cost-cutting, especially because generic manufacturers operate on slim margins.

Gralow cited an analysis showing that more than half of the drugs currently in shortage have some of the lowest prices on the U.S. pharmaceutical market. Cheap drugs are often sold at a loss, leaving manufacturers to routinely outsource their operations outside of the U.S. to keep costs down or stop producing the meds entirely.

To address this, lawmakers could implement incentives to boost U.S. manufacturing and encourage more advanced technologies such as continuous manufacturing, Gralow said.

“We will pay a greater long-term cost in the form of delayed or denied care if we do not address the underlying economic forces driving these shortages of generic drugs,” Gralow explained.

The shortages reportedly started last January when the FDA rebuked a production plant in India that was a main manufacturer of cisplatin and carboplatin. For its part, the FDA officially reported a shortage of the platinum-based chemotherapies almost one year ago, on Feb. 10, 2023.

A year later, oncologists still face “impossible choices” when forced to deviate from standard-of-care treatment, Gralow said. Sometimes, they opt for “unconventional and unproven” treatments, which makes securing prior authorization from payers even more complicated, Gralow explained.

Alternative therapies aren’t cheap, either. Nationwide, hospitals have seen an increase in expenditures estimated to be worth around $230 million per year for the substitutes, plus $360 million a year in labor, to manage the shortages, Gralow said. Meanwhile, patients risk disease progression or death.

ASCO’s latest proposals are only a few from a “long list” of suggestions proposed by stakeholders over the past decade, according to Gralow.

Last year, the organization offered a set of legislative recommendations at a U.S. House committee hearing, and it endorsed several bills aimed at preventing future shortages. More than 15 cancer meds remain in an active shortage, including standard-of-care chemotherapies cisplatin and carboplatin.

“ASCO stands ready to collaborate with Congress to advance comprehensive solutions that ensure individuals with cancer receive the lifesaving and life-prolonging treatments they require,” Gralow said in her testimony.