Lawmakers work 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 in urging seven major manufacturers of naloxone to apply for over-the-counter status for their naloxone products.
Naloxone is a medication that rapidly reverses opioid overdoses, but it is only available with a prescription and may only be distributed and dispensed by certain entities.
Despite the effectiveness of naloxone in reversing opioid overdoses, and the FDA’s public support for making the product accessible OTC, drug manufacturers have resisted applying for OTC status for their products.
Making naloxone available OTC could help increase access to this life-saving medication, both at the pharmacy counter and within community organizations, and help states effectively combat the drug epidemic, according to the lawmakers.
“The COVID-19 pandemic has dramatically exacerbated the opioid and substance use disorder epidemic in this country, with reported overdoses and deaths spiking to historic levels. In fact, alarming data show that last year, the United States experienced a record 100,306 overdose deaths. These trends show no signs of abating as overdose deaths continue to rise,” said the lawmakers. “We ask that you act quickly given the scale of need at this moment. 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 experiencing more than 100,000 overdose deaths in a 12-month period for the first-time ever last year.
A study found that substantially increased access to naloxone reduced opioid overdose mortality rates by 46 percent, the lawmakers said.
The 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 Representatives 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, M.D. (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 leading addiction recovery groups, including the American Society for Addiction Medicine and the Remedy Alliance.