Study Says FDA Program To Police Opioids Largely Failed

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Study Says FDA Program To Police Opioids Largely Failed
The study was published in the journal JAMA Internal Medicine.
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A new study says a lack of oversight by the U.S. Food and Drug Administration is hurting efforts to crack down on the inappropriate prescription of opioids. 

The study was published in the journal JAMA Internal Medicine Monday. Researchers from Johns Hopkins University looked over thousands of pages of FDA documents related to the agency's Risk Evaluation and Mitigation Strategy program, also known as REMS.

The program was established in 2012. It required the makers of extended release and long-acting opioids to fund safety training for doctors prescribing those drugs and report back on how that training was going.

But the researchers found that more than five years after the program was implemented, the FDA wasn't able to determine if it actually worked. 

The study says the FDA could've done more to estimate the program's effectiveness. And others are criticizing the agency for not being more assertive in controlling opioid prescribing, manufacturing and distribution.

In an editorial accompanying the study, a retired FDA senior executive said: "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."

When asked for comment by CNN, the FDA pointed to recent statements from agency officials that said "the opioid crisis continues to be one of the FDA's top public health priorities."

Additional reporting from Newsy affiliate CNN.