Lawmakers are working to make naloxone available over the counter

BRIDGEPORT, W.Va (WDTV) – U.S. Senators Joe Manchin and Shelley Moore Capito led a bipartisan, bicameral group of thirty lawmakers to urge seven major naloxone manufacturers to seek over-the-counter status for their naloxone products.

Naloxone is a drug that quickly reverses opioid overdoses, but it is available by prescription only and can only be distributed and dispensed by certain entities.

Despite naloxone’s effectiveness in reversing opioid overdoses and public support from the FDA to make the product available over-the-counter, drugmakers have resisted seeking OTC status for their products.

Making naloxone available over-the-counter could help increase access to this lifesaving drug, both over the counter and within community organizations, and help states effectively address the drug epidemic, according to lawmakers.

“The COVID-19 pandemic has significantly exacerbated the epidemic of opioid and substance use disorders in this country, with reported overdoses and deaths reaching historic levels. In fact, alarming data shows that last year the United States had a record 100,306 overdose deaths. These trends show no signs of slowing as overdose deaths continue to rise,” the lawmakers said. “We ask that you act quickly given the scale of the needs at this time. Lives are at stake.”

The series of letters comes as the COVID-19 pandemic has dramatically exacerbated the drug epidemic and substance use disorder crisis in this country, with the United States having seen more than 100,000 overdose deaths in a 12-month period for the very first time last year. .

Significantly increased access to naloxone reduced opioid overdose death rates by 46%, lawmakers said, one study found.

Lawmakers sent seven letters to the CEOs of Pfizer, Emergent Biosolutions, Teva Pharmaceuticals, Hikma, Akorn, Adamis Pharmaceuticals and Amphastar Pharmaceuticals.

Senators Manchin and Capito were joined by Senators Tammy Baldwin (D-WI), Maggie Hassan (D-NH), Angus King (I-ME), Susan Collins (R-ME), Sheldon Whitehouse (D-RI) , Elizabeth Warren (D-MA), Lisa Murkowski (R-AK), Amy Klobuchar (D-MN), Ben Ray Luján (D-NM), Richard Blumenthal (D-CT), Ed Markey (D-MA), Sherrod Brown (D-OH), Brian Schatz (D-HI), Jeanne Shaheen (D-NH) and Patrick Leahy (D-VT) and Reps. Carolyn B. Maloney (D-NY), Brian Fitzpatrick (R-PA ), Mark Desaulnier (D-CA), Peter Meijer (R-MI), Katie Porter (D-CA), Mariannette J. Miller-Meeks, MD (R-IA), Jim Cooper (D-TN), Peter Welch (D-VT), Alexandria Ocasio-Cortez (D-NY), Cori Bush (D-MO), Rashida Tlaib (D-MI), Ayanna Pressley (D-MA), and Jimmy Gomez (D-CA).

The lawmakers’ effort is strongly supported by major addiction recovery groups, including the American Society for Addiction Medicine and the Remedy Alliance.

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Maria D. Ervin