Manchin and Warren push for over-the-counter opioid reversal drugs

Pfizer Inc. and other drugmakers are facing calls from Congress to make their opioid reversal drugs available over-the-counter, a move by lawmakers that lawmakers say will reduce the stigma of addiction and addictions. drug-related deaths.

Thirty House and Senate lawmakers are pushing Pfizer, Teva Pharmaceuticals, HikmaEmergent Biosolutions, Amphastar Pharmaceuticals and Adamis Pharmaceuticals to apply to the Food and Drug Administration for over-the-counter status of their respective naloxone products.

The requests come in letters sent to drugmakers, along with Sens. Joe Manchin (DW. Va.), Elizabeth Warren (D-Mass.), and Lisa Murkowski (R-Alaska) and Reps. Alexandria Ocasio-Cortez (DN.Y.), Rashida Tlaib (D-Mich.) and Brian Fitzpatrick (R-Pa.) among the signatories.

Congress and the Biden administration have stepped up efforts to address the rising number of overdoses in the United States. The number of overdoses has reached historic highs during the Covid-19 pandemic, according to data from the Centers for Disease Control and Prevention.

“The COVID-19 pandemic has significantly exacerbated the opioid and substance use disorder epidemic in this country, with reported overdoses and deaths reaching historic levels,” the lawmakers said in the letters.

“The widespread adoption of opioid overdose prevention and reversal strategies has never been more important. This includes measures to increase access to affordable naloxone, which is a proven and effective tool for reducing medical emergencies, drug overdoses and deaths,” they said.

Naloxone has received particular attention in calls to fight addiction. In November, the White House Office of National Drug Control Policy provided a roadmap for states to facilitate access to reversal medication.

“All 50 states and the District of Columbia have passed legislation to improve access to naloxone. But such actions are not enough,” Brian Hurley, president-elect of the American Society of Addiction Medicine, said in a statement. “Now is the time to designate a naloxone product as an over-the-counter drug.”

The lawmakers note in their letter that the “FDA strongly supports” over-the-counter naloxone.

“The responsibility rests with the manufacturers to submit the necessary documentation to make this change,” they said.

The drugmakers did not immediately respond to requests for comment.

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