Faced with politicians accusing it of turning a blind eye to the opioid epidemic, the Food and Drug Administration is making a series of high-profile moves aimed at tackling the problem.
The agency earlier this week strengthened the labeling requirements on some popular opioids and released advice aimed at getting generic opioids with abuse-deterrent technology onto the market.
The moves come about a month after the confirmation of FDA Commissioner Robert Califf, whose nomination was put on hold by several Democratic senators angry at the agency over the opioid epidemic.
One of the senators who voted against Califf, Sen. Joe Manchin, D-W.Va., was pleased by the move to strengthen the “black box” labeling of opioids. The FDA now requires popular opioids such as Vicodin to place a black box on their labels to alert doctors and patients about the addiction risks.
“The warning label requirement is a good first step in preventing the misuse and abuse of prescription drugs, but more needs to be done,” Manchin said.
Manchin, whose state had the highest overdose rate from opioids in the country in 2014, has been a frequent critic of the FDA’s decision to approve an opioid called Zohydro without an abuse-deterrent formulation and to approve a kiddie-sized version of the painkiller Oxycontin. He opposed Califf’s nomination because he claimed the former Duke University medical researcher would be unable to change the culture at the FDA regarding opioids.
Another senator who opposed Califf called this week’s action too little too late.
“Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone,” said Sen. Ed Markey, D-Mass.
One expert says that the moves represent a shift in the agency to take on the opioid epidemic.
“I don’t think it is an accident that we are seeing increased activity on the FDA with the arrival of the new commissioner,” said G. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness.
While Alexander said that he didn’t want to suggest that former commissioner Margaret Hamburg didn’t take the issue seriously, Califf is “using his arrival as an opportunity to look at this issue anew.”
However, Alexander and one patient advocate questioned whether the moves would put a dent in an issue that federal data shows kills about 52 Americans a day.
Alexander told the Washington Examiner that the FDA should go further in its labeling requirements to note that there is an “absence of evidence of the long-term safety and effectiveness of opioids for the treatment of chronic pain.”
One advocate also commended the FDA for trying to get generic opioids with abuse-deterrent features that prevent the drug from being crushed or snorted, methods addicts sometimes use to get high faster.
Currently only a handful of brand-name drugs have the technology; there doesn’t appear to be any generic drugs with it.
But the opioids can still be taken orally, which is the way that most addicts take them, said Andrew Kolodny, executive director of the advocacy group Physicians for Responsible Opioid Prescribing.
“Our epidemic is really an addiction epidemic and if we want to bring the epidemic under control you have to prevent people from getting addicted,” he told the Washington Examiner. “Ultimately to bring it to an end you have to prevent new people from getting addicted.”
The abuse-deterrent pills don’t “get us there” because they can still be swallowed.
Another major problem is doctors may think the products are less addictive, which is not the case, Kolodny said.
“It suggests to prescribers they can worry less about these drugs, which isn’t true at all,” he added, noting that the pills are still addictive but just can’t be crushed or snorted.
The federal government is trying to clamp down on the prescribing of opioids, with officials saying that doctors prescribing too many of the painkillers have contributed to the problem.
Alexander speculated as to whether the FDA is misfiring with its focus on abuse-deterrent technology.
“I still think the FDA has a disproportionate investment in abuse-deterrent formulations as a means to bring in the epidemic,” Alexander said, noting that the agency may be expecting too much from abuse-deterrent pills.
Meanwhile, Congress appears willing to take on the issue as well. The Senate earlier this month passed a bill 94-1 that would expand access to treatment services and an overdose antidote called naloxone.
That bill was not taken up in the House before it adjourned for its two-week Easter recess.
Sen. Rob Portman, R-Ohio, the bill’s lead co-sponsor, recently said he was optimistic that the House will approve the Comprehensive Addiction and Recovery Act.
He recently told the Huffington Post that House Speaker Paul Ryan wants to be helpful on the issue.
“I got a sense that he’d like to move,” Portman said.
