The U.S. Food and Drug Administration (FDA) should immediately step in and assist efforts to replenish the nation’s continuously depleted supply of medications and stabilize the American health care system, say U.S. Sen. Bill Cassidy (R-LA) and a bipartisan group of 30 senators.
The nation’s “ongoing and worsening drug shortage crisis,” according to the senators, “threatens the health and safety of our constituents and hinders the ability of health care providers to deliver high-quality care.”
Medications consistently in short supply include local anesthetics, injectable opioids, ophthalmic diagnostics, and sterile IV fluids used to deliver virtually all drugs used in an emergency department or surgical setting, according to Sen. Cassidy, who along with U.S. Sen. Chris Murphy (D-CT) led the group of senators in requesting the FDA’s help.
“These are essential products used every day, and for many of them there are no suitable alternatives that are readily available,” the senators wrote in a June 15 letter sent to FDA Commissioner Scott Gottlieb. “This can result in suboptimal pain control or sedation for patients, and ultimately limit patient access to the most appropriate care.”
Persistent shortages across all classes of medications, they wrote, may last for months or longer and impact patient care in emergency rooms, hospitals and ambulatory surgical centers, among many other settings, according to the letter, which included the signatures of U.S. Sens. Roy Blunt (R-MO), Cory Gardner (R-CO), Orrin Hatch (R-UT), Dean Heller (R-NV) and Todd Young (R-IN).
The senators requested that the FDA convene the Drug Shortage Task Force to work with stakeholders and federal agencies on determining the main causes for the shortages. The senators also requested that the task force submit its recommendations to Congress by the end of 2019.
The lawmakers noted that “important strides” have been made since the height of the drug shortage crisis in 2012 and the subsequent enactment of the Food and Drug Administration Safety and Innovation Act.
“However, drug shortages continue to present consistent, frequent, and significant risks for patients and threaten the stability of our health care system,” they wrote.
For example, there has been a decrease over time in the number of new shortages reported annually to the FDA, but the total number of unresolved shortages continues to be a system-wide problem based on the FDA’s own data, the senators wrote.
Additionally, “the damage inflicted upon certain drug manufacturing facilities by Hurricane Maria in 2017 not only exacerbated these existing shortages, but exposed just how fragile our current system is, highlighting the need to take action to improve redundancy and preparedness in our supply chain,” wrote the members.
The lawmakers said they recognize there are many other factors contributing to the drug shortages across the United States and told Commissioner Gottlieb, “We believe that a better understanding of how these factors interact with one another and the degree to which they affect shortages can help shape policy actions.”