The Food and Drug Administration (FDA) wants to make access to the opioid antidote naloxone more readily available to individuals, families, first responders and communities in an effort to reduce the number of opioid overdose deaths.
There are three FDA-approved forms of naloxone – injectable, auto-injector and nasal spray. All three are currently available by prescription. Most states have tried to reduce the barriers that prevent consumers from easily accessing the opioid reversal agent by allowing pharmacists to dispense naloxone under a standing order or directly to consumers.
“Still, many pharmacists may be unaware of the standing orders and direct authority in their states or are unwilling to provide all forms of naloxone to consumers without an individual prescription,” said Acting FDA Commissioner Norman E. “Ned” Sharpless, M.D. in a statement.
Another issue that impedes access to these treatments is that there is a misconception that the cheapest form of naloxone – the injectable version – cannot be used outside the health care setting. “All three forms of naloxone are FDA-approved and may be considered as options for community distribution and use by individuals with or without medical training to stop or reverse the effects of an opioid overdose,” he said.
The FDA is also granting priority review to manufacturers of generic products that can be used to treat opioid overdoses in an effort to bring over-the-counter naloxone to the market.
“Ultimately, the goal of increasing access to all forms of naloxone is to make this potentially life-saving treatment available to individuals at risk of an overdose — such as those with a history of overdose or substance use disorder — and those in the community most likely to observe an overdose,” Sharpless said.
The opioid epidemic has claimed more than 47,000 lives in 2017, according to the Centers for Disease Control and Prevention (CDC).
Beasley Allen has an Opioid Litigation Team that includes these lawyers: Rhon Jones, Parker Miller, Ryan Kral, Rick Stratton, Will Sutton, Roger Smith and Jeff Price. This team represents the State of Alabama, the State of Georgia, and numerous local governments, as well as other entities in multidistrict litigation.