FDA chief ’s long-promised opioid review faces skepticism

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.

The 453-page report issued five years ago this month by the National Academies of Sciences laid out a strategy for reducing overprescribing and misuse of opioids, with particular focus on the FDA.

At the center of the recommendations was a proposal for the FDA to reassess the dozens of opioids being sold to determine whether their overall benefits in treating pain outweigh their risks of addiction and overdose. Those that don't should be removed from the market, the group said.