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Does the FDA’s Plan to Regulate New Opioids More Strictly Go Far Enough?

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A bottle of liquid oxycodone, an opioid pain relief medication, and a dose of the solution sit on a table in Washington, D.C., on March 29th, 2019.

Nearly a year after a major panel recommended it, the Food and Drug Administration has released new standards for how officials will evaluate new opioid drugs for approval to be sold in the United States. The proposed guidelines formally say that the FDA will consider opioids’ effects on the wider public, not just whether they work if they’re taken as intended, which is a first. But at least one advocacy group says it’s not enough.

“If this is their view of what should go into a opioid framework, that is not acceptable,” says Sidney Wolfe, a drug-safety expert with the consumer advocacy group Public Citizen, who previously served on an FDA advisory committee. Public Citizen has petitioned the FDA to stop approving any new opioid painkillers until it starts using stricter rules.

Typically, when deciding whether to approve a new drug, the FDA only looks at the risks and benefits to patients who take it as directed, not risks to everyone else. But in July of last year, a panel of scientists organized by the National Academies of Science, Engineering, and Medicine recommended the FDA create a special, stricter process just for opioids. The overprescribing of opioid painkillers played a critical role in creating the addiction and overdose epidemic in America today, the National Academies found, and so the FDA has an “important gatekeeping function” to play in keeping riskier new opioids from entering the market. The call for a tougher opioid approval process was underscored in November of last year, when the FDA OK’d an opioid called Dsuvia, generating intense controversy. Dsuvia is 10 times more powerful than fentanyl, an already-potent opioid that’s the driver of overdose deaths in America. Groups, including Public Citizen, called the approval dangerous. The FDA argued that restrictions on Dsuvia’s distribution would minimize its risk.



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