FDA Plots Path to Expanding Access to Opioid Overdose Antidote
An upcoming advisory committee meeting will focus two US Food and Drug Administration (FDA) committees’ attention on increasing the availability of the opioid overdose drug naloxone.The meeting will ask external advisors from the FDA’s Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees to consider various options for increasing access to naloxone.
“They will help us weigh logistical, economic and harm reduction aspects of different strategies. And we will consider whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” FDA Commissioner Scott Gottlieb said in a statement.
But he explained that such a decision on co-prescribing could incur significant costs and burdens, including practical considerations such as the need for manufacturing volume growth for naloxone, and the risk of drug shortages of this product that could come from a sudden spike in prescribing.
He also noted that FDA is making progress in turning naloxone into an over-the-counter (OTC) drug (Focus previously explored why naloxone is not an OTC product), explaining the importance of the consumer-friendly Drug Facts Label (DFL), which is required for OTC drug products.
“We recognized the important public health opportunity to bring naloxone OTC. So, to further encourage companies to enter this space, the FDA created a model DFL and simple pictogram. And we are in the process of conducting label comprehension testing for this product,” Gottlieb said. “This is the first time the FDA has proactively developed this OTC framework for a drug as a way to help activate the advance of OTC products.”
Erin Britt, a spokesperson for CVS Health, told Focus the chain has pharmacy locations in 48 states (Hawaii and Wyoming do not) that currently have a standing order or similar protocol allowing pharmacists to dispense naloxone to patients without an individual prescription.
The committees’ discussion will touch on the idea of making naloxone an OTC drug, and it will also discuss what community organizations and local municipalities across the US have done to develop programs for making naloxone available.
GAO Report
Sens. Patty Murray (D-WA) and Elizabeth Warren (D-MA) on Tuesday publicly released a GAO report on the public health emergency declared over the opioid crisis.
Since declaring the opioid crisis a public health emergency, the federal government has used three available authorities, but GAO identified 14 other authorities that became available as a result of the public health emergency and have not been used.
"Communities are desperately in need of more help to address the opioid epidemic. President Trump, as this report shows, has broken his promises to do his part,” Warren said.
Murray added: "This report is more evidence that while President Trump has made big promises to score headlines about the fight against opioid addiction, he doesn't care enough to follow through on them with the sweeping actions needed to address the crisis with all the tools available.”
Trump, meanwhile, is expected to sign a major opioid bill into law on Wednesday.
Statement from FDA Commissioner
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee