A new study, published Monday in the journal JAMA Internal Medicine, has found that the U.S. Food and Drug Administration (FDA) cannot prove that its key strategy of addressing opioid misuse and abuse actually worked.
Researchers looked at more than 9,700 pages of FDA documents associated with the agency’s “risk evaluation and mitigation strategy.” The strategy was launched in 2012 to address risks linked to long-acting and extended-release opioids.
The researchers wrote, “Although these drugs can be clinically useful among appropriately selected patients, they have also been widely oversupplied, are commonly used nonmedically, and account for a disproportionate number of fatal overdoses.”
The FDA required the drug manufacturers to offer education on safe opioid prescribing and medication guides informing patients about the potential risk in order to combat inappropriate prescribing, misuse and abuse of opioids. It also advised manufacturers to provide reports on “prescriber behavior” and “patient safety.”
The strategy was implemented approximately 5 years ago and the FDA has failed to assess whether these outcomes were actually achieved, according to the authors.
In 2013, one author concluded that the FDA “lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety.”
The researchers said the agency could have done more to study the strategy’s effectiveness. The agency has also been criticized for not taking more aggressive action.
Former FDA senior executive William Hubbard said, “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.”
“Instead of bold, effective action, the FDA has implemented the Risk Evaluation and Mitigation Strategy programs that … do not even meet the limited criteria set out by the FDA,” he added.
Hubbard said the FDA could have taken one important action by putting restrictions on opioid distribution.
He said, “Restricting opioid distribution would be a major decision for the FDA, but it is also likely to be the most effective policy for reducing the harm of opioids.” “It is time that the federal government got serious about regulating opioids,” added Hubbard.
