In response to the nation's opioid abuse epidemic, the U.S. Food and Drug Administration has announced that it will change its policies on reviewing new painkillers. It will also carefully consider any new labeling for pediatric use of the drugs.
The agency said it was “re-examining the risk-benefit paradigm for opioids.” A news release announcing the new approach said the FDA wants to consider opioid drugs' wider public health effects.
As initial steps, the FDA vowed to:
“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” Dr. Robert Califf, the FDA's deputy commissioner for medical products and tobacco, said in a statement. “This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis.”
The plan also addresses some concerns that have prompted several lawmakers to block Califf's nomination as the next FDA commissioner. The White House announced Califf as its pick in September.
But Sen. Edward Markey (D-Mass.), who in January placed a hold on Califf's nomination, said the FDA's plan was “not enough” to address the ongoing opioid crisis that led to a record 25,000-plus overdose deaths in 2014. Markey criticized the agency's decision to limit the use of an advisory committee review for only those prescription painkillers that don't have abuse deterrents.
Currently, four senators have said they plan to block Califf's nomination for varying reasons.
The FDA also said it plans to strengthen the requirements for drug companies to generate postmarket data on the long-term effects of opioid use. The agency said it “expects this to result in the most comprehensive data ever collected in the field of pain medicine.”