The agency said it was “reexamining the risk-benefit paradigm for opioids.” A press release announcing the new approach said the FDA needed to consider opioids’ wider public health effects.
As initial steps, the FDA vowed to: consult with independent advisory panels prior to the approval of some new pain relievers; improve access to naloxone, often used for narcotic overdoses; and provide medication-assisted treatment options for patients with opioid addictions, among other objectives.
“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 of the concerns that have caused several lawmakers to block Califf’s nomination to be the next FDA commissioner. The White House announced Califf as their pick in September.
Sen. Edward Markey (D-Mass.), who in January placed a hold on Califf’s nomination, stated 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.
“Until the FDA commits to convene advisory committees of outside experts for all its opioid-approval decisions, I will continue my hold on Dr. Califf’s nomination,” Markey said in a statement.
Currently, four senators have said they plan to block Califf’s nomination, for varying reasons.
Sen. Joe Manchin (D-WV), who has vowed to hold a vote on Califf over concerns about his handling of opioid abuse, stated he was “not impressed” by the FDA’s response, and that more needed to be done to change the agency’s culture.
“I will continue to push for the strongest possible framework for drug approval to ensure that the agency doesn’t simply continue to approve ever stronger and more deadly opioid medications under this new process,” Manchin said in a statement.
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.”
HHS has put forth a similar evidence-based initiative that focuses on clarifying opioid-prescribing practices.