Letter to Dr. Stephen Ostroff, Administrator of the Food and Drug Administration - Over the Counter Status for Overdose Death Prevention Drug

Letter

Dear Administrator Ostroff:

We are writing to request that you use your administrative or rulemaking authority to reclassify Naloxone from a prescription drug to an over-the-counter drug. The arguments for such action are profound and convincing.

First, as you well know, overdose deaths are near or at an epidemic level in the United States, approaching 50,000 per year , greater than car accidents and firearms deaths combined. 28,000 of these deaths were from prescription opioids in 2014 . More than 10 percent of high school students use prescription opioids for non-medical use. Invariably, and for any number of reasons, some of these children will accidentally overdose. Steps must be taken to provide swift and immediate treatment to manage acute overdose of opioids.

Bold action is needed to combat the effects of addiction. Reclassifying Naloxone from a prescription drug to an over-the-counter drug will, without a doubt, save lives. Naloxone swiftly reverses heroin and opioid overdoses, while having no pharmacological effect if administered to a person who has not taken opioids, and it has no potential for abuse. Making this drug available over-the-counter would be an important step in making sure people can access it in crucial life-or-death moments.

We applaud your efforts to date in combating this epidemic and we urge you to use the authority you have by law to make Naloxone available over-the-counter.

Sincerely,

REP. ALAN GRAYSON REP. DANA ROHRABACHER REP. BILL FOSTER

REP. ALMA S. ADAMS, Ph.D.
REP. SEAN PATRICK MALONEY
REP. MARK DESAULNIER
REP. CHELLIE PINGREE
REP. ROSA DELAURO
REP. ELIJAH E. CUMMINGS
REP. ELIZABETH ESTY
REP. CHRIS VAN HOLLEN
REP. DONNA EDWARDS
REP. RICK LARSEN
REP. JOHN SARBANES
REP. CHARLIE RANGEL