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FDA News Release

Federal Government Announces New Pilot Program to Help Stop Illegal Availability of Unapproved Opioids Online

For Immediate Release:

The U.S. Food and Drug Administration and the National Telecommunications and Information Administration (NTIA) are launching a 120-day pilot to help reduce the availability of unapproved opioids illegally offered for sale online.

Under the pilot, the FDA will notify internet registries that are participating in the pilot – Neustar, Verisign and Public Interest Registry – when the agency sends a warning letter to a website operator and the website operator does not respond adequately within the required timeframe. The internet registries will review the FDA’s notifications and assess whether to take further voluntary action, including possible domain name suspensions or blocks. The NTIA, a branch of the U.S. Department of Commerce, responsible for telecommunications and information policy issues, will work with the internet registries involved in the pilot, and partner with the FDA to assess its impact.

“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,” said HHS Secretary Alex Azar. “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.”

“The trusted notifier pilot program is another new policy tool in President Trump’s fight to end the opioid crisis,” said Secretary of Commerce Wilbur Ross. “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.”

At the end of the pilot, the agencies will analyze its effectiveness as a potential solution to dealing with the illegal sale of unapproved opioids online.

The FDA remains committed to addressing the national opioid crisis on all fronts, with a continued focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and taking action against those who contribute to the illegal sale and importation of unapproved opioids.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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