FDA Announces Sweeping Changes In Approach To Opioid Drugs

The FDA announced today that it planned sweeping changes in its approach to opioids drugs. The move comes in response to growing concerns over abuse of prescription opioids in the US and escalating criticism of the FDA’s lackluster response to the problem. Two US Senators have said they would oppose President Obama’s nomination of Robert Califf to be the next FDA Commissioner at least in part because of their opposition to FDA opioid policy and actions.

Here are some of the key elements of the FDA’s plan:

  • More advisory committee meetings. The FDA said that it will now require an expert advisory committee before it approves any new opioid drug that does not have “abuse-deterrent properties.” Advice from expert panels will now be sought more frequently.
  • The FDA will change the labels for immediate-release (IR) opioid products to include “additional warnings and safety information” similar to those now contained in labels for extended-release and long-acting (ER/LA) opioids.
  • Companies will be required to continue to study drugs after they are on the market to assess the long-term impact of ER/LA opioids.

The FDA said it would also update its Risk Evaluation and Mitigation Strategy (REMS) Program for opioids, expand access to abuse-deterrent formulations (ADFs) of opioids, and broaden access to overdose treatment with naloxone.

Finally, the FDA said it would “reassess the risk-benefit approval framework for opioid use.” In this regard the FDA has already commissioned a report on opioids from the National Academy of Medicine and has scheduled a meeting of its Science Board in March. One expert, Andrew Kolodny, chief medical officer at Phoenix House, told MedPage Today that this item “could be a game changer if the FDA takes it seriously– but that’s a big if.”

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Califf, in an FDA press release. “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.”

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” added Califf. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

But Kolodny said that the FDA announcement did not go far enough. Most of the proposals “will have little impact,” he told MedPage Today. Kolodny said that the “FDA should be holding advisory meetings for all opioids- not just the ones lacking so-called abuse-deterrence.” Kolodny said that he hopes Massachusetts Senator Markey– one of the senators holding up Califf’s nomination– will tell the  FDA that advisory panels should be required for all opioids.

Kolodny said he supported the plan to strengthen the label on immediate release opioids. “This means they are likely to change the indication from ‘moderate to severe pain’ to ‘severe pain’, and add language about pregnancy risks and addiction risk. But it does not look like they’ll add an upper dose limit, a duration of use limit or language that would limit marketing for chronic pain.”

Another senate critic of the FDA, Joe Manchin of West Virginia, said that he appreciated but was not impressed by the FDA plans. “It is past time that the FDA gets serious about the dangers of prescription drugs,” he said. He also called for the FDA to convene advisory panels for all opioids. He said he was also “frustrated with the FDA’s reluctance to accept its own advisory panels’ recommendations.”

–with additional reporting from Kristina Fiore



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