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Wednesday, Jun 6 2018

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FDA Puts Bad Actors On Notice: Agency Is Cracking Down On Illegal Online Opioid Sales

The extent of the FDA鈥檚 direct enforcement authority is unclear, but the agency warned companies that fail to correct violations outlined in the warning letters that they could have their products seized or face other legal action.

The Food and Drug Administration on Tuesday morning outlined a framework for cracking down on illegal opioid sales on the internet. Hours later, FDA Commissioner Scott Gottlieb delivered results: a list of nine online operators, running a combined 53 websites, to which it had sent formal warnings for having engaged in illegal marketing and sales of highly controlled opioid painkillers. 鈥淭he FDA is taking additional steps to protect U.S. consumers from illicit opioids by targeting the websites that illegally market them and other illicit drugs,鈥 Gottlieb said in a statement. 鈥淭he internet is virtually awash in illegal narcotics and we鈥檙e going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales.鈥 (Facher and Swetlitz, 6/5)

The FDA warned 53 websites Tuesday that they must stop "illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications," including tramadol and oxycodone. "The internet is virtually awash in illegal narcotics and we鈥檙e going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales," FDA Commissioner Scott Gottlieb said in a statement. Gottlieb warned that it will take action against firms whose websites "deliberately break the law." (Hellmann, 6/5)

鈥淭hese sites are always going to exist. There鈥檚 going to be new ones that pop up,鈥 FDA Commissioner Scott Gottlieb told POLITICO. 鈥淎s we continue to take enforcement action and following through those actions with more vigorous enforcement, I think it鈥檚 going to send a strong deterrent.鈥 (Pittman, 6/5)

In other news on the crisis聽鈥

Voters in this struggling Rust Belt region in upstate New York, backed Donald Trump in the 2016 presidential election, hoping he could help turn back a relentless tide of factory and business closures. But the starkest symptom of decline there - an opioid epidemic that has claimed the lives of hundreds in and around the city of Binghamton - rages on, and voters are demanding that candidates for public office address the loss of life. (Gibson, 6/5)

A report released on Tuesday from the University of New Hampshire is shining a light on those living in the shadows of the state鈥檚 opioid epidemic: the children who live with their parents鈥 addictions. The study says the number of children or youths removed from parental care increased by nearly 200 from 2012 to 2016, and cases that included a substance-related allegation doubled from 30 percent to 60 percent. The Carsey School of Public Policy conducted the research and consulted several child welfare organizations, including the Division for Children, Youth and Families, and more than 40 experts from New Hampshire. (6/6)

State Rep. Kim Moser will transition from her role as former executive director to member of the Drug Control Policy Board as her responsibilities in the Kentucky General Assembly continue to grow. ... Meanwhile the Drug Control Policy Board will expand, bringing more allies to the battlefield to combat this growing epidemic of drug addiction. (Reinert, 6/5)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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