For the past five years, the number of new drug shortages reported to the U.S. Food and Drug Administration (FDA) was declining steadily. However, in 2017, the number grew from 26 to 39 – representing a 50-percent increase – according to a new report from the agency.
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 auto-injectors. Additionally, Baxter International, 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.
The AMA also acknowledged the severity of the problem, calling it an “urgent public health crisis” and urging the Department of Health and Human Services and the Department of Homeland Security to investigate the drug shortages.
“Physicians strive to provide the best possible care to their patients, which means being able to obtain the right drugs at the right time,” William E. Kobler, MD, AMA board member, said in a press release. “The fact that drug shortages worsened when major hurricanes struck drug-production facilities on Puerto Rico highlights the need to evaluate and plan for hazards that pose a threat to critical infrastructure for manufacturing pharmaceutical and medical products.”
Sources: AMA press release, June 12, 2018; FDA press release, June 19, 2018; FiercePharma, June 20, 2018.