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FDA launches new pilot program to crack down on unapproved opioids sold online

pharmafile | June 9, 2020 | News story | Manufacturing and Production FDA, opiod crisis, opioids 

The FDA is collaborating with the National Telecommunications and Information Administration (NTIA) to launch a pilot program to reduce the availability of unapproved opioids illegally sold online.

The program will last 120 days, and under it the FDA will notify participating registries, Neustar, Verisign and Public Interest Registry, and send a warning letter to them if they do not respond adequately within the timeframe. The internet registries will then review the FDA’s warnings and assess whether to take further action which may include possible domain name suspensions or blocks. This will help crack down on sites selling unapproved opioids, which can be ordered and delivered throughout the US.

The NTIA will work with the registries involved in the pilot and assess the schemes impact with the FDA. Wilbur Ross, the Secretary of Commerce who oversees the NTIA, said: “The trusted notifier pilot program is another new policy tool in President Trump’s fight to end the opioid crisis. The Commerce Department is eager to work with our partners at HHS, FDA, and the domain name registries to remove a major channel for the sale of illicit opioids, which will help save many American lives.”

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At the end of the scheme, both agencies will analyse whether it is an effective long-term solution to dealing with the illegal sale of opioids online.

Alex Azar, Secretary of the Department of Health and Human Services, said: “Cooperation between the Department of Health and Human Services and the Department of Commerce, with the addition of the pilot program, will help stop the online sale of illicit opioids and combat our country’s deadly addiction crisis. Stopping abuse of illegal opioids, including those sold online, has been one of President Trump’s top health priorities. The men and women of FDA have worked tirelessly over the years with the private sector and federal partners, like NTIA, to fight illegal online opioid sales.”

Back in late 2019, the FDA and Drug Enforcement Agency sent a joint letter to multiple websites warning them to stop illegally marketing and selling opioids. They also have been cracking down on illegal online pharmacies that are often run by criminal gangs and sell either unapproved or counterfeit medicines.

Conor Kavanagh

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