FDA Rejects Petition For Moratorium On New Opioids

By Kelly Burch 09/12/19

The FDA explained its decision to continue accepting applications for new opioids in a written response. 

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FDA employee rejecting petition for moratorium on new opioids

The Food and Drug Administration has rejected a request for a moratorium on the approval of new opioid drugs.

The petition for a moratorium was launched by the Public Citizen’s Health Research Group in April of this year. It requested that the FDA hold off on approving new opioids until the organization adopted recommendations made by the National Academies of Sciences, Engineering, and Medicine’s 2017 report, "Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use."

The FDA issued a written response to the request last week, denying the petition. 

Why The FDA Denied The Request

“While the FDA is committed to continuing its ongoing work of scrutinizing how it applies its benefit-risk framework to candidate opioids, and to exploring whether additional authority from Congress is needed, FDA must also continue to apply the existing statutory and regulatory framework to properly filed [new drug applications], including applications for new opioid drug products or opioid formulations,” the agency wrote. 

“Furthermore, a moratorium on the approval of new opioid drug products could stifle the development and availability to patients of new opioids that could offer greater safety or other therapeutic advantages over products already on the market.”

The FDA went on to state that even after a new drug is approved, it is still closely monitored to make sure that its benefits outweigh its risks. The FDA has taken steps to mitigate the risk of opioids, including changing labeling, the agency says. 

Approving A New Opioid That's Stronger Than Fentanyl

Last year, the FDA ruffled feathers by approving a controversial new opioid that is 10 times stronger than fentanyl. The medicine, Dsuvia, is a version of sufentanil intended only for use in hospitals, the FDA said. Many people, including a member of the FDA’s own advisory committee, spoke out against the approval of the drug. 

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Dr. Sidney Wolfe of Public Citizen’s Health Research Group (the same group that requested the moratorium) said in a press release at the time. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”

Raeford Brown Jr., MD, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee spoke strongly against the approval of the drug, even writing an open letter in opposition: 

“It is my observation that once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” he wrote.

“Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.”

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Kelly Burch writes about addiction and mental health issues, particularly as they affect families. Follow her on TwitterFacebook, and LinkedIn.

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