FDA chief's long-promised opioid review faces skepticism

WASHINGTON (AP) — As U.S. opioid deaths mounted in 2016, the incoming head of the Food and Drug Administration promised a “sweeping review” of prescription painkillers in hopes of reversing the worst overdose epidemic in American history.

Dr. Robert Califf even personally commissioned a report from the nation’s top medical advisers that recommended reforms, including potentially removing some drugs from the market. But six years later, opioids are claiming more lives than ever, and the FDA has not pulled a single drug from pharmacy shelves since the report's publication. In fact, the agency continues putting new painkillers on the market — six in the last five years.

Now Califf is back in charge at the FDA, and he faces skepticism from lawmakers, patient advocates and others about his long-promised reckoning for drugs such as OxyContin and Vicodin, which are largely blamed for sparking a two-decade rise in opioid deaths.

“All the concerns that we had at the time on opioids are still there. We still have a really huge problem,” said Richard Bonnie, a University of Virginia public health expert who chaired the committee that wrote the report.

Bonnie and his co-authors say the FDA seems to have incorporated several of their recommendations into recent decisions, including a broader consideration of a drug’s public health risks. But they say there is more to be done.

In an interview with The Associated Press, Califf said a new internal review of opioids has been underway for months and that the public will soon “be hearing a lot more about this.” While the review will look at past FDA decisions, Califf suggested the focus will be on future policy.

“It seems like people love sort of looking back and fault-finding, but I’m much more interested in learning so we can go...