FDA sends warning letters to websites illegally selling opioids

pharmafile | September 11, 2020 | News story | Medical Communications  

The FDA has issued warning letters to 17 websites for illegally selling unapproved or misbranded opioids. 

This is due to these companies violating the Federal Food, Drug and Cosmetic Act which was passed in 1938 to give the FDA authority to oversee the safety of drugs. 

The opioids that these companies sold included tramadol and oxycodone, which have significant risks of addiction and misuse and have led to overdose and death in thousands of Americans during the opioid crisis. 

Donald D. Ashley, the Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said: “Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis. We remain committed to using all available tools to stop the illegal sale of opioids online to help protect consumers from these potentially dangerous products.”

The companies have 15 days to respond to the warning letter and outline the steps they will take to address selling these opioids. 

From 1999-2018, almost 450,000 people have died from overdosing on both illicit and prescription opioids. The first wave of the opioid crisis began in the 1990s with the over-prescription of opioids from doctors and pharmacies. The second wave began in the 2010s and included the rapid increase of overdoses from heroin, while the third wave began in 2013 which largely involved deaths from synthetic opioids like fentanyl. 

President Donald Trump made fighting the opioid crisis a key campaign promise back in 2016; however, since then his administration has achieved relatively little on the issue. Trump did sign the Support for Patients and Communities Act, which took largely regulatory steps to expand access to addiction treatment and research regarding opioid addiction and pain, and the Republican-controlled Congress did include $500 million in the Cures Act as part of the 2018 budget.

Conor Kavanagh

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