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FDA Call to Action on Opioids Met With Skepticism
Alicia Ault
February 23, 2016

The US Food and Drug Administration's (FDA's) recent announcement that it would re-evaluate its labeling and review policies for opioids seems to be largely a political move designed to fend off congressional critics, say pain management and addiction medicine specialists.

The agency's action plan, announced on February 4, included a call for a re-examination of the risk-benefit paradigm for opioids, changes to immediate-release opioid labeling, improved access to naloxone, and new advisory committee meetings to address pediatric approval issues and any new opioid that does not have abuse-deterrent properties.

"It's obviously a reaction to the pressure they're getting from Congress," Edward Michna, MD, director of the Pain Trials Center at Brigham and Women's Hospital and instructor at Harvard Medical School, Boston, Massachusetts, told Medscape Medical News. Dr Michna, a board member of the American Pain Society, said he believes the FDA's plan doesn't go much beyond what it has already been doing.

Andrew Kolodny, MD, executive director for Physicians for Responsible Opioid Prescribing, said he believed that the FDA announcement was prompted by several senators announcing that they would block a vote on the nomination of Robert Califf, MD, for FDA commissioner. "This is, at least in part, a public relations effort," Dr Kolodny told Medscape Medical News.

Dr Califf's nomination was unanimously approved by a Senate committee in January. But a handful of senators have announced "holds" on the confirmation — an informal process that lets their colleagues know that they will filibuster the nomination when it comes to the floor for a vote. Sen. Edward J. Markey (D-Mass) and Joe Manchin (D-WVa) said they'll block a floor vote because of what they believe to be the FDA's weak response to opioid misuse.

The agency's plan has not alleviated concerns, said Sen. Markey. "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," said the senator in a statement.

The FDA's proposals are "a step in the right direction, but they are not enough given the devastating impact that opioid abuse and overdose death has had on our country," said Sen. Manchin, in a statement of his own.

The FDA declined a request for interviews for this report. In a call with reporters announcing the opioid plan, Dr Califf said it was not a direct response to the senatorial holds. However, he said, "it's fair to say we heard what Congress had to say."

On February 22, the Senate voted 80 to 6 to invoke cloture and move forward with Dr Califf's nomination as FDA commissioner, surpassing the 60 votes needed to invoke the procedure, and removing the holds that had been put on the proceedings. Senators Manchin and Markey were among those who voted "no" for cloture.