FDA can't prove effectiveness of opioid safety strategy, analysis finds

FDA can't prove effectiveness of opioid safety strategy, analysis finds

The Food and Drug Administration (FDA) can’t prove that a program intended to curb opioid misuse and improper prescribing was ever effective, according to an analysis of newly uncovered documents.

The analysis, published Monday in the journal JAMA Internal Medicine, found that the FDA never collected the right data to determine the effectiveness of the program in reducing addiction or changing physician prescribing practices. 

The authors from the Johns Hopkins Bloomberg School of Public Health reviewed more than 9,700 pages of FDA documents gained by Freedom of Information Act requests related to the agency’s risk evaluation and mitigation strategy (REMS).


The strategy was launched in 2012 to address risks tied to extended-release and long-acting opioids, which were more associated with greater risk of addiction, unintentional overdose and death than their immediate-release counterparts.

The REMS program was intended to be the FDA’s primary tool “to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse,” according to the researchers. 

Yet the authors found that “more than 5 years after implementation, the FDA was unable to assess whether these outcomes were achieved.”

Under the program, the FDA required opioid manufacturers to pay for voluntary safety training for physicians who prescribe the drugs, and to track the effectiveness of the training. 

The researchers found the REMS program was implemented “largely as planned,” but when its shortcomings became known, “FDA instead changed the goal” of the assessments, instead of improving them. 

The agency could have done more to study the program’s effectiveness, and has come under fire for allowing drug companies to fund prescriber training. Prior assessments of the REMS program have also been funded by opioid manufacturers, and a May 2016 FDA advisory committee noted “methodological concerns” regarding the studies.

In an editorial accompanying the analysis, retired senior FDA official William Hubbard called on the FDA to take more aggressive action, and said the agency has “broad authority” to restrict the distribution of dangerous medications.

FDA “has tools that could mitigate opioid risks more effectively if the agency would be more assertive in using its power to control opioid prescribing, manufacturing, and distribution,” Hubbard said.