Health research group Public Citizen's founder, Sidney Wolfe, believes a moratorium on opioid production is necessary because new opioids and reformulations of opioids have more known risks than benefits.
The petition for moratorium was sent on April 5 to the U.S. Department of Heath & Human Services, as well as the FDA Commissioner on behalf of Sidney Wolfe and Raeford E. Brown Jr., Professor of Anesthesiology and Pediatrics at the University of Kentucky.
Wolfe and Public Citizen believes that there needs to be a complete halt on new opioid productions until a new framework is in place and it is successful.
Wolfe told the FDA Reporter, “41 new opioid formulations were FDA approved from 1997 to 2015 and 59 percent of those new formulations were approved in the last 7 years.”
The increase of opioid approval was happening “while there was a rapid increase in the U.S. mortality rate due to the effects of opioids, both prescription and illicit.”
Public Citizen believes the lack of oversight to the acceleration of the new formulation approvals and the opioid crisis was not examined properly by the FDA.
In March 2016, the serving FDA commissioner at the time, Robert Califf, asked the National Academies to review the current FDA opioid regulations and help develop a regulatory framework to improve it.
Wolfe said that he commended the National Academies proposed framework and “the major finding explicitly being that the FDA had failed to adequately incorporate public health considerations into opioid-related regulatory decisions.”
“Now, it has been three years since the FDA asked for the National Academies to help develop a safe regulatory framework for opioids and the FDA has failed to implement those recommendations,” Wolfe told the FDA Reporter.
Public Citizen is now asking for Janet Woodcock, current director of the Center for Drug Evaluation and Research at the Food and Drug Administration, to step down from her position, as it believes she is continuing to add to the opioid epidemic by not swiftly implementing the National Academies framework.
“Woodcock pretended publicly in 2017 that this was the first time the FDA had enough evidence that they needed to do something about opioids, which is simple not true,” Wolfe said.
“The ongoing danger of the deficient FDA regulation of opioids provides a strong case for a moratorium on any future opioid approvals until the National Academies-recommended framework is operational.”
Wolfe previously served on the FDA’s Drug Safety and Risk Management Advisory Committee from 2008-2012.