FDA Finds Drug Shortages Rising Again After Five Years of Progress

After declining for five years, the number of new drug shortages in the U.S. grew from 26 to 39 in 2017, representing a 50 percent increase, according to a report from the U.S. Food and Drug Administration (FDA). While this number is substantially lower than the peak of 250 drug shortages reported in 2011, many of the current shortages are of critical drugs, including painkillers, intravenous fluids, and epinephrine.

FDA Deputy Center Director for Regulatory Programs Douglas Throckmorton, MD, released a statement acknowledging the severity of the problem. “These shortages greatly impact patient treatment options,” he said, “and require practitioners to make difficult decisions that can compromise care, such as rationing supplies or using less desirable, but more readily available, alternative therapies.”

The agency attributes the growing number of shortages to production problems at Pfizer facilities in Kansas and Missouri, including the plant responsible for producing epinephrine for use in Mylan’s autoinjector. Additionally, Baxter, the nation’s largest supplier of intravenous drugs, was hobbled last year after its facilities in Puerto Rico were left without power in the aftermath of Hurricane Maria.

Dr. Throckmorton emphasized the FDA’s commitment to alleviating the harm caused by these shortages and called for “a mix of industry cooperation, regular communication, and the flexible use of the FDA’s regulatory authorities.” These efforts, he believes, will mitigate the public health impact of the drug shortages.

Sources: FiercePharma, June 20, 2018; FDA press release, June 19, 2018.