According the US Food and Drug Administration (FDA) the number of new drug shortages in the US has jumped to 39 last year from 26 in the two prior years. While 39 is still significantly lower than the 250 registered in 2011, FDA acknowledges that the shortages “are having a tangible impact on patients,” reported FiercePharma.
The critical shortages included Mylan’s EpiPen and injectable painkillers to mundane IV fluids. In a statement from FDA on June 19, “these shortages greatly impact patient treatment options 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.”
At one of the largest drug makers, Pfizer, there were several manufacturing problems which resulted in shortages for FDA and the healthcare system. Shortages of injectable opioid analgesics used in hospitals were due to an FDA warning letter for a Pfizer facility in Kansas. FDA has been working with Pfizer and other drug makers to combat shortages, but there is still concern that the problem will persist into 2019.
FDA also dealt with the hurricanes which ripped through the Caribbean last year, leaving plants in Puerto Rico of the biggest supplier of IV fluids without power to produce. Some hospitals had to ration their saline solution and amino acid products. The power issue on the island has now been resolved but it will still take time before stockpiles can be fully restored.
Some members of Congress wonder whether FDA is doing all it can to resolve the shortage problems. According to Fierce Biotech, 31 senators sent a letter to Commissioner Scott Gottlieb urging him to address “our nation’s ongoing and worsening drug shortage crisis.”
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