In New Report, FDA Advisors Echo Senator Hassan’s Calls for FDA to Update its Opioid Labelling Policies as Overdose Deaths in NH Remain High

WASHINGTON – A recent report from The Ohio State University, commissioned by the Food and Drug Administration (FDA), echoes Senator Maggie Hassan’s calls for the FDA to update its policies for labelling opioid prescriptions. The report comes as overdose deaths in New Hampshire remain high.

The new report underscored the lack of evidence for the long-term efficacy of prescription opioid use and called on the FDA to remove these unsupported claims from opioid labels. In a statement responding to this new report, FDA Commissioner Robert Califf acknowledged that there is a lack of evidence on the effectiveness of long-term prescription opioid use -- a point that Senator Hassan has made multiple times -- and said that the FDA will hold an advisory committee meeting in April to evaluate the long-term efficacy of opioids.

“Far too many people develop an opioid addiction that started with a legal prescription, which is why it’s incredibly irresponsible that opioids can be prescribed for long-term use despite the lack of evidence on their effectiveness,” Senator Hassan said. “We have known for a long time that there is little evidence for the efficacy of opioid use over the long-term, and I am encouraged that the FDA finally acknowledged that these claims are unsupported. I now urge the agency to follow the advice of its external advisors to quickly revise its opioid labelling policies and remove this debunked claim from prescription opioid labels.”

Senator Hassan is leading efforts to address the opioid crisis. Last year, she and Senator Mike Braun (R-IN) called on the FDA to update its policies for labelling opioid prescriptions, including removing unsupported claims about opioids’ long-term efficacy. She also previously pressed Dr. Califf during a Senate hearing to address the opioid crisis by changing the labeling guidance for opioid prescriptions. Additionally, during Dr. Califf's nomination hearing, Senator Hassan called on him to address FDA’s inaction on opioid misuse and failure to fix labeling guidance issues for opioids, and she pressed him on the FDA’s approval of OxyContin.

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