Wide swath of online opioid sellers warned by FDA

Regulatory NewsRegulatory News
| 10 September 2020 | By Kari Oakes 

Seventeen website operators recently received warning letters from the US Food and Drug Administration (FDA) for selling unapproved and misbranded opioids. The letters were issued on 31 August 2020 to operators of websites based in China, Iceland, India, New Zealand, Pakistan and the United States.
Operators of the websites, which carry names such as “www.buydrugsmedsonline.com” and “www.beststeroidstore.net,” were warned for offering opioids such as oxycodone and tramadol for sale without a prescription and without adequate directions for use. Some of the sites also offered unapproved formulations of opioid drugs for sale to US customers.  
“Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release announcing the agency’s actions. “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.”
In June 2020 FDA announced it was partnering with the US Department of Commerce on a 120-day pilot program to reduce the online sale of illicit opioids. The pilot was designed to take aim at website operators who do not have an adequate or timely response to FDA warning letters by notifying internet registries of the operators’ noncompliance.
The registries, which hold the virtual keys to domain names, may then choose to take such voluntary actions as locking or deleting domains or placing a hold on the domain name. (RELATED: FDA takes aim at online opioid sellers with new pilot, Regulatory Focus 08 June 2020)
Previous actions by FDA to fight illicit online opioid sales included a sweeping set of warning letters issued in 2018 to nine online networks that ran 53 websites illegally offering opioids for sale. (RELATED: FDA warns Korean, Australian drugmakers, online opioid sellers, Regulatory Focus 05 June 2018)
“Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering,” notes the most recent suite of warning letters in their opening paragraphs. “Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.”
The warned operators were instructed to take “prompt action” to correct the violations FDA noted, and to report their actions to the agency within 15 days of the letters’ date of issuance. At press time, many of the websites were still offering the opioids that were the subject of the warning letters. One site, Iceland-based www.mega-pillspharmacy.com, featured a note on its landing page that read, “NB: Contact us if you can’t find what you need. Some Products have not been listed for reasons Mega Pills Pharmacy deems necessary.”


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Tags: FDA, opioids, US

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