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WASHINGTON — Under pressure to stop the US epidemic of opioid abuse and related deaths, the Food and Drug Administration on Thursday launched a plan to toughen warning labels, improve treatment of both addiction and pain, and expand the use of abuse-deterrent medications.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, in a statement.


“Things are getting worse, not better, with the epidemic of opioid misuse, abuse, and dependence. 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.”

The timing may be fortuitous for Califf. The former Duke University physician-scientist was nominated by President Barack Obama to head the FDA last September, but his confirmation has run into roadblocks in the Senate.

Two of the four senators vowing to block or filibuster a confirmation vote have expressed concern over the FDA’s policies on opioids. Both Edward Markey of Massachusetts and his Democratic colleague Joe Manchin of West Virginia have criticized the agency for not doing more to address the nationwide epidemic. 


Last month, Markey, said he was especially troubled that the FDA approved OxyContin for children in 2015 without first convening an expert advisory panel, as the agency often does, while Manchin took issue with Califf’s ties to the drug industry, including companies that make opioids.

Among the FDA’s new plans to reverse the opioid epidemic — which Califf and other agency leaders outlined in a policy paper published Thursday in the New England Journal of Medicine — are expanded use of expert advisory committees; developing warnings and safety information for immediate-release opioid products; and requiring drug manufacturers to better monitor cases of misuse and abuse.

In addition, FDA plans to train more prescribers on safe pain management, and spur generic development of tamper-resistant drug formulations. The agency also plans to seek advice from the National Academy of Medicine.

The changes were met with skepticism by one expert. “If they really do reexamine the risk-benefit paradigm, it would be a game changer,” Dr. Andrew Kolodny, chief medical officer at Phoenix House, a nonprofit that runs drug abuse treatment and prevention programs, told STAT. “But it’s hard to know if they’re sincere about it.”

“There may be some public relations here,” Kolodny noted.

Indeed, the FDA’s move appears to address some of the issues that caused lawmakers to block Califf’s nomination. But it won’t be clear sailing for Califf.

“We have serious concerns with the proposal, even if it is a good start,” a spokeswoman for Markey said in an email. “Senator Markey will not be releasing his hold on Dr. Califf’s nomination as he doesn’t feel these proposals go far enough.”

In a recent move related to Senator Lisa Murkowski’s unease over Califf, the FDA revised its guidelines on genetically modified fish, now requiring such products to be labelled. A spokesman for Murkowski, an Alaska Republican, said she was still studying the issue.

If the three lawmakers do accept the recent FDA moves and free their holds on Califf, he still has one final faultfinder to win over: Bernie Sanders.

The Vermont Senator and Democratic presidential hopeful’s main issues with the FDA nominee: industry ties and rising prescription drug prices.

Ed Silverman contributed to this report.

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