FOR IMMEDIATE RELEASE
Date: February 25, 2015
Contact: Ken Scudder, 202-578-1903
Grayson Calls for Over-the-Counter Status for Overdose Death Prevention Drug
~ Letter to FDA Enjoys Bipartisan Support from Foster, Rohrabacher, 12 Others ~
WASHINGTON, DC – Congressmen Alan Grayson (D-FL09) sent a letter to Dr. Stephen Ostroff of the Food and Drug Administration (FDA) asking him “to use your administrative or rulemaking authority to reclassify Naloxone from a prescription drug to an over-the-counter drug.” Naloxone is a nasal inhalant used to prevent deaths in people who have overdosed on an opioid like OxyContin or heroin.
Reps. Dana Rohrabacher (R-CA48) and Bill Foster (D-IL11), along with 12 other members of the House of Representatives, added their signatures to Grayson’s letter.
The World Health Organization estimates that greater access to Naloxone would prevent 20,000 opioid overdose deaths in the US each year. Naloxone blocks opioids from working on the brain and nervous system, while also reversing their effects on respiratory depression, which can cause overdose victims to stop breathing. It has no pharmacological effect if administered to a person who has not taken opioids, and it has no potential for abuse.
The full text of the letter follows this release; a copy of the signed letter is attached.
“Reclassifying Naloxone as over-the-counter would save thousands of lives every year,” Congressman Grayson said. “This is a quick, risk-free step that the FDA can take to respond to the heroin and opioid epidemic that has spread across the nation.”
“Current regulatory law must not stand in the way of saving lives,” said Congressman Rohrabacher. “A proven antidote to overdoses must be readily available, and so a regulatory adjustment needs to be made urgently.”
“Increasing access to Naloxone will save lives,” said Congressman Foster. “Since 2000, heroin overdoses have killed more Americans than the war in Vietnam. Making Naloxone an over-the-counter drug is a common-sense solution to help reverse the growing number of deaths from heroin and opioid addiction.”
Studies show that the vast majority of overdose victims are not alone when they overdose. Reclassifying Naloxone as over-the-counter would be an important step in making sure the drug can be accessed and administered while waiting for emergency medical services teams to arrive.
Congressman Alan Grayson represents Florida’s 9th Congressional District, which includes Osceola County, as well as parts of Orange and Polk counties.
Grayson.House.Gov
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Congress of the United States
Washington, DC 20515
February 23, 2016
Dr. Stephen Ostroff, M.D.
Administrator
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
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
