FDA warns websites for illegally marketing opioids
The FDA issued warning letters to two online networks for illegally marketing unapproved, misbranded and potentially harmful opioids, such as tramadol, requesting immediate seizure of sales to consumers, according to a press release issued by the agency.
“To combat the opioid epidemic, we need to work across all of our authorities to reduce exposure to opioid drugs in the medical setting, advance innovations that can offer non-addictive alternatives for the treatment of pain, promote the development and awareness of therapies that can help those currently addicted to opioids, and target the illegal sale of illicit drugs online and through the mail,” Scott Gottlieb, MD, commissioner of the FDA, said in the release.
“The illicit sale of opioids online is a particularly critical concern as the nature of the epidemic shifts from one where new addiction was primarily formed in the medical setting, to a crisis where more and more of the new exposure is through illicit drugs,” he added.
Despite being marketed as safe, opioids purchased from illegal online sites may endanger patients’ health as they may be counterfeit, contaminated, expired or unsafe, according to the FDA.
The websites that received warning letters include azmedicinalshop.com and thedonrx.net. The companies have 15 working days to respond and inform the FDA of the actions they will take to address their violations of the Federal Food, Drug, and Cosmetic Act. Failure to correct violations may result in further regulatory action, according to the FDA.
Today’s action by the FDA add to its warning letters to more than 450 websites since September 2017, according to the release.
The FDA stated that preventing websites from selling illegal opioids requires collaboration across the online community. The FDA has developed partnerships with internet companies, such as Google, Facebook and Instagram, to deindex concerning websites and redirect users seeking to purchase opioids online to a government help line, according to the release.
Disclosure: Gottlieb is the commissioner of the FDA.