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Senator Hassan Presses the FDA Commissioner to Update Opioid Labeling Policies: “What People are Looking for Right Now is Action”

WASHINGTON – At a U.S. Senate Health, Education, Labor, and Pensions Committee hearing yesterday, U.S. Senator Maggie Hassan pressed Food and Drug Administration (FDA) Commissioner Dr. Robert Califf on the need to update the FDA’s harmful labeling policies that continue to play a role in fueling the opioid crisis in New Hampshire. Senator Hassan also asked about taking lessons from the COVID-19 pandemic to inform the administration’s response to monkeypox.

To watch Senator Hassan’s questioning, click here.

During the hearing, Senator Hassan pressed FDA Commissioner Califf on addressing the opioid crisis by changing the labeling guidance for opioid prescriptions.

“The opioid epidemic continues to ravage communities in New Hampshire and all across the country…and your agency needs to move swiftly to correct its previous mistakes,” said Senator Hassan. “You yourself have repeatedly said that the FDA needs high quality evidence to support the long-term use of opioids. The agency has the authority to remove labels from drugs now given the absence of this evidence.”

When Senator Hassan asked why the process is taking so long, Dr. Califf responded that the FDA is actively considering relabeling.

Senator Hassan then underlined the urgency to address this crisis, stating that “I just was at a recovery rally in my state with people who have engaged in peer-to-peer recovery, people who are helping pregnant women with their recovery…parents who have lost two children to fentanyl and to opioids. The FDA first approved and labeled opioids for long-term use more than 25 years ago. That means that they have been on the market for more than 25 years without substantial evidence that they are effective for that purpose – and with plenty of evidence about the harm that these drugs can cause...What people are looking for right now is action.”

Previously, during Dr. Califf’s nomination hearing, Senator Hassan discussed how the FDA helped fuel this crisis by approving and labeling opioids for long-term use – despite a lack of evidence supporting those labels, and Senator Hassan subsequently voted against Dr. Califf’s confirmation given her concerns about lack of FDA action. In April, Senator Hassan joined Republican Senator Mike Braun of Indiana in again pushing the FDA to update its opioid labeling policies.

In addition to discussing opioid labeling, during the hearing Senator Hassan asked Department of Health and Human Services Assistant Secretary Dawn O’Connell how the department’s experience with COVID-19 is informing its monkeypox response.

O’Connell discussed how based on the department’s work addressing COVID-19, it is digitizing and modernizing systems for states to order monkeypox therapies and the vaccines and expanding distribution capacity.