GOP Senators Question FDA’s Response to Opioid Epidemic

(Washington, D.C., October 19, 2022) – Today, U.S. Senators Roger Marshall, M.D., James Lankford (OK), Shelley Moore Capito (WV), and Marsha Blackburn (TN) sent a letter to the U.S. Food and Drug Administration (FDA) questioning the agency’s response to stopping the opioid epidemic. The letter follows industry feedback on the FDA’s lack of communication and clarity regarding its guidance for the development of new non-addictive pain medicine. The FDA’s guidance has had a significant impact on manufacturer development timelines and potential new treatment options for both patients and health care providers.

In their letter, the Senators wrote in part,

“The opioid epidemic affects millions of Americans. Since 1999, more than 932,000 people have died from a drug overdose, and the rates have only accelerated in recent years… While FDA has made efforts to confront the opioid crisis over the past several years, opioid addiction, abuse, and misuse remain major public health issues across the country… In February, FDA issued the guidance providing recommendations to pharmaceutical manufacturers developing non-opioid analgesics for acute pain lasting up to 30 days… No new analgesic medications were approved in 2021. The few pain management drugs that were approved by the FDA in the immediately preceding years were primarily in migraine or postoperative pain indications… The need for better engagement is underscored by an industry report highlighting that clinical success in drug development has been extremely difficult for this therapy class… It is our understanding that this issue has not been resolved and has caused delays in development timelines and potential new options for patients… Now is the time to provide patients with safe and effective non-opioid alternatives to prescription opioids for pain management…”

The Senators concluded their letter with a series of questions for the FDA related to the agency’s efforts to fully execute provisions in the SUPPORT for Patients and Communities Act for developing non-addictive pain medications, and requested the FDA answer their questions no later than November 9, 2022.

You may click HERE to read the Senators full letter to the FDA.