Will the FDA’s Suggestions Help Curb Drug Shortages?

Drug shortages, especially of older and less expensive medications, are increasing, causing hospitals to ration lifesaving treatments. According to a report released in late October by a U.S. Food and Drug Administration (FDA) task force, the number of ongoing shortages has reached 110. In many cases, manufacturers stopped producing the drug before a shortage occurred for business-related reasons, such as reduced profitability.

“There’s a market failure here,” Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, told STAT. “The market doesn’t follow the textbook model of supply and demand. Prices often don’t rise substantially during a shortage, so there’s little incentive for manufacturers to increase production or stay in production.”

The task force’s report includes several suggestions for solving the growing problem: collecting more information about shortages, rating manufacturers on the quality of their product, and extending financial incentives to manufacturers, focusing on ways to “shift some financial risk and uncertainty away from producers of drugs, especially older generics.”

Some of the drugs in shortage over the past several years include vincristine, a critical treatment for leukemias, lymphomas, and brain tumors; nelarabine, which is considered the standard of care for T-cell acute lymphocytic leukemia (ALL); and immune globulin.

Sources: STAT, October 29, 2019; The Wall Street Journal, October 29, 2019; FDA report, October 29, 2019.

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