FDA Issues New Opioid Guidelines, But Critics Say They’re Not Enough

By Kelly Burch 06/28/19

The new guidelines say that the FDA should consider whether or not a new opioid works better than existing pain relief options.

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The Food and Drug Administration (FDA) has issued new guidelines about how it should consider applications for approval of new opioids, but some critics are questioning whether the new plan does enough to restrict the harm of potentially deadly medications. 

The FDA issued the new guidelines on June 20. The guidelines are meant to give a risk-benefit analysis over how new opioids will help patients who use them correctly, but also how they may affect people using opioids illegally. This is a departure for the agency, which usually only considers a drug’s safety when it is taken as prescribed. 

“Opioids present unique challenges: they have benefits when used as prescribed yet have very serious risks and can cause enormous harm when misused and abused,” the agency said in a statement released at the same time. 

Still, some people don’t think that the guidelines are enough to prevent the FDA from approving drugs that could worsen the opioid epidemic. One consumer advocacy group, Public Citizen, has demanded that the FDA halt approval of all new opioids until stricter guidelines are in place. 

Sidney Wolfe, a former member of an FDA advisory committee and a policy expert for Public Citizen, told Pacific Standard that she was not satisfied with the new guidelines. 

"If this is their view of what should go into a opioid framework, that is not acceptable," she said. 

The new guidelines say that the FDA should consider whether or not a new opioid works better than existing pain relief options. However, the guidelines don’t require that the agency reject approval for medications that do not work better than existing options, Wolfe said.

In addition, the guidelines say that the agency will consider how opioids could be misused, but it does not require companies to provide information on potential misuse before they are given FDA approval. The guidelines are not legally binding. 

Despite these shortcomings, some people who are in favor of stricter oversight over opioids are happy to see the guidelines issued. 

"What I can say is that we are pleased that the agency has taken this first step in implementing our recommendations,” said University of Virginia professor Richard Bonnie, chair of a National Academies panel that called on the FDA to develop a special process for approving new opioids. 

The FDA has come under fire for its role in the opioid epidemic. 

“The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced,” a spokesperson for the agency told Vanity Fair for a recent article. “Sadly, the scope of the epidemic reflects many past mistakes and many parties who missed opportunities to stem the crisis, including the FDA.” 

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