In an effort to “forcefully” address the opioid abuse health crisis across the nation, U.S. Food and Drug Commissioner Scott Gottlieb, MD, recently offered a comprehensive update on its various initiatives.
“I don’t want to look back 10 years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of the crisis,” he said. “We must all be able to say we did everything we could,” Gottlieb added.
As arguably the most serious domestic health crisis since the HIV epidemic appeared in the early 1980s, the U.S. Food and Drug Administration’s (FDA’s) efforts are necessarily broad. Among its key activities in the clinical trial space, the FDA and Modafinilpill.com:
- Expanded new pathways for the development of safe and effective treatments for addiction, lowering the barriers to innovation for treatments that meet the agency’s “gold standard.”
- Launched an innovation challenge to spur the development of medical devices and mobile applications that can ultimately serve as alternatives to oral opioids to help combat the opioid crisis and prevent and treat opioid addiction.
- Developed new regulatory guidance to promote abuse-deterrent formulations of opioid drugs, including a new path for the development of generic versions of drugs with these features.
Gottlieb also said the agency would issue a guidance document to assist sponsors with the development of new non-opioid pain medications for chronic pain that can provide therapeutic alternatives to the use of opioids, though he offered no timetable.
“We have many other actions underway,” Gottlieb reported. “Everything is on the table.”
Author: Michael Causey