Dem senators urge FDA to remove powerful opioids from the market

A trio of Democratic senators is urging the Food and Drug Administration (FDA) to remove ultra-high dose opioids from the market as policymakers grapple with how to stem the tide of the opioid epidemic.

Sens. Joe Manchin (D-W.Va.), Dick Durbin (D-Ill.) and Ed Markey (D-Mass.) say that powerful opioids — those exceeding 90 milligrams of morphine per day — should be taken off the shelves due to concerns about “accidental ingestion, borrowed medication, and recreational use.”

A citizen petition to do so is already on file at the FDA. A citizen petition allows the public to request the FDA to make policy changes.

“We urge you to heed this important, potentially life-saving request,” the senators wrote Thursday in a letter to FDA Commissioner Scott Gottlieb. “We appreciate your commitment to using all tools at the FDA’s disposal to help address the opioid crisis.”

The senators said patients who already take high doses of opioids for cancer and other conditions could still receive the treatment they need by taking multiple pills, patches or other formulations.

“We believe these ultra-high dose opioids can be removed from the market without imposing hardship on those with legitimate pain needs,” the letter states.

The concept isn’t without controversy. Some opponents say getting rid of high dose opioids could be unsafe for patients who need the medicines to manage their pain.

In response to the citizen petition, the Academy of Integrative Pain Management wrote that it opposed the move on several grounds. It would “in some situations, create a greater danger because patients would be required to have several times more pills available to meet their needs,” the association wrote.

“The burden of this would fall on the sickest patients, including those with cancer and/or receiving palliative/hospice/end-of-life care, whose quality of life would be diminished.”

An estimated 115 Americans die each day due to overdose deaths involving opioids. The number of deaths has increased every year since 1999 and has shown no sign of slowing down.