Bipartisan Group of Senators Ask FDA to Report Drug-Shortage Solutions to CongressBy
A bipartisan group of 31 US senators has asked US Food and Drug Administrator (FDA) Commissioner Scott Gottlieb to have the agency provide recommendations to Congress on how to address nationwide drug shortages by no later than the end of 2019.
In a letter to Gottlieb dated June 15, 2018, the senators ask the FDA to convene the Drug Shortage Task Force, which was created by the Food and Drug Administration Safety and Innovation Act of 2012, as well as stakeholders and other relevant agencies, to develop a report and recommendations to Congress regarding the root causes of drug shortages.
“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,” the senators said in the June 2018 letter.
Particularly, the senators referred to the shortage of “essential” medications, including local anesthetics, injectable opioids, ophthalmic diagnostics, and sterile IV fluids. “In fact, in a recent member survey conducted by the American Society of Anesthesiologists, 98% of respondents indicated they regularly experience anesthesia drug shortages, and 95% said the shortages adversely affect patient care,” the senators noted in the letter.
Following the letter, Douglas Throckmorton, the Deputy Director for Regulatory Programs for the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA), issued a statement to provide an update on how the FDA is addressing drug shortages for what it considers “critical” products, including saline, opioid analgesics (pain medications), and EpiPen, Mylan’s self-injectable epinephrine products used for emergency-care situations.
Source: Office of Senator Chris Murphy