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30 August 2018Americas

FDA warns 21 websites over misbranded opioid drugs

The US Food and Drug Administration (FDA) has warned 21 websites over the illegal marketing of misbranded versions of opioid medications.

On Tuesday, August 28, four online networks, which operate the websites, were told to immediately stop illegally selling the medications to American consumers.

The medications, which are being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe, said the FDA.

Addressing the opioid addiction crisis is one of the FDA’s highest priorities and supports the US Department of Health and Human Services’  “5-Point Strategy To Combat the Opioid Crisis”.

Scott Gottlieb, FDA commissioner, said: “Cutting off this flow of illicit internet traffic in opioids is critical, and we’ll continue to pursue all means of enforcement to hinder online drug dealers and curb this dangerous practice.”

The FDA has sent a total of 13 warning letters to more than 70 websites this summer.

In June, the FDA hosted stakeholders at an Online Opioid Summit, which discussed ways to work together to take “stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online”.

Yesterday, Gottlieb outlined the agency’s ongoing work to address the crisis.

He explained that, over the past 17 months, the FDA has set out to address the opioid crisis “forcefully” across three broad areas.

First, the FDA set out to cut the rate of new addiction, in part by taking new steps to rationalise the prescribing of opioids, and amounts dispensed.

The FDA’s warnings to online retailers fall under the second category of stepping up enforcement against the marketing and sale of illicit opioids. More enforcement actions are on the way.

“We also formed a broad collaboration with legitimate internet sites—including leading social media platforms—to target the sale of opioids in ways that are visible to the public, and in some ways that are not apparent,” said Gottlieb.

As part of the second category, the agency has also expanded its oversight of drugs being shipped illegally through international mail facilities. The FDA is now able to open and inspect nearly ten times more packages than before.

Third, the agency has undertaken efforts to support novel product innovation, including for treatments for opioid addiction, and also to promote more widespread use. This includes steps to advance the development of non-addictive treatments for pain.

Gottlieb said: “I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis. We must all be able to say we did everything we could. That we acted as aggressively as needed. And that we succeeded.”

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More on this story

Americas
30 August 2018   Life sciences company Emergent BioSolutions announced plans to acquire Adapt Pharma earlier this week, in what the company said was an effort to combat the public health threat from opioid overdose.
Big Pharma
1 October 2019   The US Food and Drug Administration and Drug Enforcement Administration have issued joint warning letters to four online networks which allegedly sell unapproved and misbranded versions of medicines.

More on this story

Americas
30 August 2018   Life sciences company Emergent BioSolutions announced plans to acquire Adapt Pharma earlier this week, in what the company said was an effort to combat the public health threat from opioid overdose.
Big Pharma
1 October 2019   The US Food and Drug Administration and Drug Enforcement Administration have issued joint warning letters to four online networks which allegedly sell unapproved and misbranded versions of medicines.