Study: FDA Failed to Improve Opioid Oversight Despite Known Deficiencies

Tobias Hoonhout

A study released Monday found that the U.S. Food and Drug Administration’s “risk evaluation and mitigation strategy” to handle rising opioid abuses were never improved, despite lacking the data to determine the program’s effectiveness.

Conducted by researchers at the Johns Hopkins Bloomberg School of Public Health, the study reviewed more than 9,700 pages of FDA documents through a Freedom of Information Act request to see whether a 2011 opioid-oversight program was effective in reducing addiction, overdoses and deaths.

While “the REMS program was implemented largely as planned,” the study concluded that “more than 5 years after implementation, the FDA was unable to assess whether these outcomes were achieved.”

The FDA’s strategy involved mandating that drugmakers offer education to doctors on safe prescribing and medication guides to inform patients of risks, with corresponding reports back to the agency.

But while the REMS program followed the assigned protocols, only 27.6 percent of doctors had gone through educational programs from 2012 to 2016, well below the expected benchmark of 60 percent. The study also showed that the FDA could not determine whether the safety protocols were working, because its preapproved studies were not collecting the right data.

The REMS program was flagged from the beginning, with an FDA advisory committee voting against the program’s design in 2010, before again citing “methodological concerns” in 2016. An 2013 inspector general report also concluded that the FDA “lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety.”

But despite these concerns, the study showed that the FDA never instituted improvements to the REMS program.

“What’s surprising here is the design of the program was deficient from the start,” Caleb Alexander, the senior author of the study who also serves as a paid-expert witness in litigation against opioid manufacturers and distributors, told The New York Times. “It’s unclear why the F.D.A. didn’t insist upon a more scientifically rigorous evaluation of this safety program.”

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