Manchin, Capito lead effort to make naloxone available over the counter

CHARLESTON, WV (WVNS) — Today, April 12, 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, drug manufacturers have resisted applying for OTC status for their products.

“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 lawmakers continued, “Given the scale of need at this moment, it has never been more important to adopt opioid overdose prevention and reversal strategies on a wide scale. This includes steps to increase access to affordable naloxone, which is a proven, effective tool to reduce medical emergencies, drug overdoses, and deaths… Further, a formal switch to OTC status will help reduce stigma and encourage the widespread use of this critical medication during emergencies. Additionally, market prices for naloxone remain prohibitively high, putting additional financial strain on community organizations working to reduce overdoses.”

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