A Rutgers expert and former FDA official is available to comment on a consumer advocacy group’s call for the agency to impose a moratorium on any new or reformulated opioids.
The current chair of the Food and Drug Administration’s analgesics advisory committee has also joined the petition, saying the agency has displayed “dangerously deficient oversight” and that none of more than two dozen opioids approved between 2009 and 2015 provide benefits that outweigh the risks.
“The FDA is charged with assuring that the medications used in the U.S. are both safe and effective,” said Lewis Nelson, chair of the department of emergency medicine at Rutgers New Jersey Medical School and a former chair of FDA’s Drug Safety and Risk Management Advisory Committee. “Despite the limited data to support the effectiveness of opioids beyond the first few days and the very clear safety issues associated with this class of medication, new opioids and new formulations continue to be approved.
“Although their hands are somewhat tied by regulations, the FDA could be doing more to raise the bar for approval and credible use of opioids,” he continued. “This is critical to stem the consequences of addiction, abuse, overdose and hyperalgesia that currently plague the nation and have directly fed the ever-expanding fentanyl epidemic that we are now battling.”
Nelson can be reached through Tiffany Cody: [email protected], (O) 973-972-3501, (M) 973-856-0517.
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