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FDA to Hold Hearing on Naxolone Use

On Thursday, the Food and Drug Administration (FDA) will hold a public hearing to consider making naloxone more available outside of conventional medical settings in order to reduce drug overdoses from opioid drugs such as OxyContin, Percocet and heroin. This groundbreaking hearing will bring together many of the leading overdose prevention experts in the United States to strategize ways to improve access to naloxone.

Naloxone rapidly reverses an opioid overdose by blocking the effects of heroin, OxyContin and other drugs. Emergency room physicians and paramedics routinely administer naloxone to a person experiencing an opioid overdose. Since receiving FDA approval in 1971, naloxone is believed to have saved tens of thousands of lives. In advance of the FDA hearing this week, the Drug Policy Alliance is releasing a new policy brief, Expanding Access to Naloxone: Reducing Fatal Overdose, Saving Lives. The brief details how naloxone is already saving lives, and includes steps that policymakers and public health officials can take to further reduce fatal overdoses.

Interest in expanding access to naloxone comes as unintentional drug overdose rates nationwide have reached unprecedented levels. In 2009, the most recent year data is available, drug overdoses exceeded the number of fatalities from motor vehicle crashes for the first time. More than 28,000 people now lose their lives each year as a result of an accidental drug overdose.

Given the enormous death toll we are seeing from opioid overdoses, it is both encouraging and crucial that the FDA has begun examining how to build on naloxone's track record as a life-saving medication, said Grant Smith, federal policy coordinator with the Drug Policy Alliance. While the FDA looks to dismantle regulatory hurdles that stand in the way of expanding naloxone access, federal lawmakers should be investing in scientific research that will expedite greater public access and use of this medication. Making naloxone available over the counter is a regulatory change that is urgently needed and cannot continue to be overlooked, said Smith.

A growing number of state and local health authorities have launched overdose prevention programs to train first responders, parents and others about how to recognize an overdose, provide first aid, and administer naloxone. Similar in concept to CPR or the use of defibrillators, overdose prevention programs are training people in more than 180 programs that are operating in fifteen states and District of the Columbia. According to a recent CDC Morbidity and Mortality Weekly Report, increased access to naloxone through overdose prevention programs has already saved more than 10,000 lives. On Friday, a panel of overdose prevention experts who presented at the FDA hearing will speak to congressional staff on Capitol Hill about the effectiveness of expanding naloxone access through overdose prevention programs.

"Lawmakers and public health stakeholders need not wait for instructions from the FDA when the tools to dramatically reduce fatal overdoses are already easily available," said Meghan Ralston, harm reduction coordinator for the Drug Policy Alliance. In addition to implementing overdose prevention programs, lawmakers should also implement 911 Good Samaritan policies, said Ralston.

States such as New York, Illinois, Connecticut and Florida have recently passed 911 Good Samaritan laws, a no-cost solution that encourages people to quickly report an overdose to emergency medical professionals without fearing arrest for minor drug possession. Hundreds of college campuses across the country also have similar policies in place.


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