The U.S. Food and Drug Administration will require new, tougher labeling for immediate-release opioid pain medications that will include a boxed safety warning about misuse in an effort to combat the current drug abuse epidemic.
The move comes as the nation is experiencing a record number of overdose deaths. In 2014, more than 47,000 Americans died from drug overdose.
In addition to the warning about immediate-release medications, the FDA is also requiring all opioid products to include additional safety information that explains the risks involved with such drugs interacting with other medications.
“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said FDA Commissioner Dr. Robert Califf in a released statement. “Today's actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”
The action is the agency's latest effort to improve its response toward a crisis some say the FDA had a partial hand in creating because of the widespread availability of powerful, prescription opioid pain relievers.
According to the Centers for Disease Control and Prevention, as many as 249 million painkiller prescriptions were written in 2013 alone. The U.S. accounts for 99% of the global sales of hydrocodone and 81% of the world's consumer market for opioids in general despite making up only 5% of the world's population, according to the American Society of Interventional Pain Physicians (PDF).
Some say the FDA should have more strictly regulated drugs with such a high risk of addiction.
Such was the case in 2013, when the FDA approved the drug Zohydro, the first pure hydrocodone medication that had no safeguards to prevent abuse. The agency came under fire then when it went against its own advisory panel's recommendations, which voted against approval.
Opioids became a major sticking point for some lawmakers after the White House last September named Califf as their nominee to take over the FDA. Several lawmakers, including Democratic Sens. Joe Manchin of West Virginia and Ed Markey of Massachusetts, blocked Califf's confirmation to force the agency to take a tougher stance on opioid drug abuse.
Califf responded to the criticism by announcing a set of policy changes in February that included new labeling requirements for pediatric use of opioids and the use of an advisory panel prior to the approvals for some pain relievers.
One area where the FDA stopped short in taking action had to do with following calls from health officials to apply a “black box” safety warning for the risks involved in combining pain relievers with anti-anxiety medications, which they say has contributed to the sharp rise in overdose deaths.
“The FDA is also aware of, and carefully reviewing, available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids,” the agency stated. “Once a review of all available scientific information is completed, the FDA will take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.”
The FDA announcement came on the same day members of the House Oversight and Government Reform Committee held a hearing where law enforcement officials and health and local government leaders highlighted some of the strategies they have employed to try to curb opioid overdoses.
Among those testifying was Dr. Leana Wen, Baltimore City Health Department Commissioner who has been one of the leading voices calling for the FDA to include a black box warning.
Speaking in front of lawmakers, Wen called for increased funding to combat the drug epidemic in Baltimore. Some of the steps Wen has taken include declaring a public health emergency and issuing a citywide prescription for naloxone, which counters the effects of a drug overdose.
“While we have done much in Baltimore City, communities across the country need further support from the federal government to expand funding for on-demand, evidence-based addiction treatment for this disease that continues to afflict millions of Americans,” Wen said. “Addiction does not discriminate. There is much we can do as local jurisdictions, but we must continue to work in partnership to address this public health crisis.”