(WASHINGTON, D.C.)--Congressman Jamie Raskin joined Reps. Eliot L. Engel (D-NY) and Brett Guthrie (R-KY) and 91 bipartisan lawmakers in sending a letter to Acting Commissioner of the Food and Drug Administration (FDA) Norman “Ned” Sharpless to urge the FDA to address critical medical drug shortages.
Drug shortages of critical medicines such as epinephrine and ketamine can hinder the delivery of high-quality patient care. A variety of factors ranging from environmental disasters to issues with manufacturing standards can disrupt the supply of medical drugs, threatening patient care by leading to:
• Substitution of recommended treatments with alternatives therapies
• Compromising or delaying critical medical procedures
• Rationing drug doses
In one recent example, U.S. hospitals struggled to administer cancer drugs due to a nationwide shortage of saline solution.
The frequency of drug shortages has spiked in recent years. In 2018, there were 186 new drug shortages, a 27% increase from 2017 and the most in the last five-years. On June 12, 2018, the American Medical Association declared drug shortages a public health crisis. The FDA, under then Commissioner Scott Gottlieb, established the Agency Drug Shortages Task Force to identify the root causes of drug shortages and advance potential long-term solutions in a report to Congress.
This bipartisan letter to Acting Commissioner Sharpless intends to remind the FDA that addressing drug shortages is a priority for Congress and asks for the release date of the task force’s report.
“I have heard first hand from my constituents in the Bronx and Westchester about the catastrophic consequences of not having access to life-saving medications because there is a shortage,” said Rep. Engel. “While Congress has taken steps in the past to minimize the impact of these shortages, more must be done. I’m pleased to have Rep. Guthrie help me lead this letter, which will help us gain insights from public health experts to prevent drug shortages in the future.”
“The last thing any patient wants to hear is that they cannot receive adequate treatment due to a drug shortage,” said Rep. Guthrie. “Nationwide shortages of saline and epinephrine, among other important drugs, have directly impacted Kentuckians. The FDA must ensure that Americans are able to get the drugs they need. Thank you to Rep. Engel for working with me to ensure the FDA makes this a top priority.”
“New York’s hospitals and health systems are too often forced to divert critical resources to addressing drug shortages which impact patient care,” said Healthcare Association of New York State (HANYS) President Bea Grause, RN, JD. “We thank Rep. Engel for his work to implement effective long-term solutions to this recurring problem to ensure that our members can focus on what they do best – caring for patients.”
“Ensuring that essential drugs are available for safe surgical procedures remain a priority for ASA,” said America Society of Anesthesiologists President Linda J. Mason, M.D., FASA. “This letter is an important reminder that Congress and the FDA must continue working to identify all causes of drug shortages and develop recommendations to ensure appropriate supplies of essential medications are always available. We applaud Congressman Engel and this bipartisan group of lawmakers for their commitment to high quality care and patient safety, and look forward to working with them on solutions to this ongoing problem.”
“Drug shortages pose a significant threat to patient care. ASHP believes new policy solutions are needed to help limit and, ultimately, prevent future shortages. We thank Congress for their attention and appreciate Reps. Engel and Guthrie’s leadership on an issue that impacts the care of all of our patients,” said Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP, CEO of American Society of Health-System Pharmacists.
“With drug shortages continuing to threaten the ability of hospitals to provide the lifesaving medications their patients need, it has never been more important for the FDA’s Drug Shortage Task Force to identify the root causes of the problem and advance long-term solutions,” said Greater New York Hospital Association (GNYHA) President Kenneth E. Raske. “GNYHA has met with the FDA about drug shortages and participated in the task force’s stakeholder listening sessions, and we eagerly await the release of its report. New York’s hospital community applauds Representatives Engel and Guthrie for their leadership on this extremely important issue.”
“Ensuring a comprehensive and timely response to ongoing critical prescription drug shortages is paramount to preserving patient care,” said Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja. “The FDA has taken important steps to address drug shortages, including forming the Drug Shortage Task Force and holding a public meeting. HSCA and its member group purchasing organizations (GPOs) look forward to the release of the Task Force’s findings and to continuing to work with Congress, FDA and all stakeholders to safeguard patient access to essential medications.”
A copy of the signed letter is available here.