FDA Puts Bad Actors On Notice: Agency Is Cracking Down On Illegal Online Opioid Sales
The extent of the FDA’s 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.
Stat:
FDA Targets Websites Illegally Marketing Opioids
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. “The 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,” Gottlieb said in a statement. “The internet is virtually awash in illegal narcotics and we’re going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales.” (Facher and Swetlitz, 6/5)
The Hill:
FDA Cracks Down On Online Sales Of Unapproved Opioids
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’re 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)
Politico Pro:
FDA Orders Illegal Online Pharmacies To Stop Selling Opioids
“These sites are always going to exist. There’s going to be new ones that pop up,” FDA Commissioner Scott Gottlieb told POLITICO. “As we continue to take enforcement action and following through those actions with more vigorous enforcement, I think it’s going to send a strong deterrent.” (Pittman, 6/5)
In other news on the crisis —
Reuters:
Voters In Opioid-Plagued Districts Demand Solutions From Candidates
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)
Concord (N.H.) Monitor:
Cases Of Children Taken From N.H. Families Doubled In Four Years, Spurred By Drug Problems
A report released on Tuesday from the University of New Hampshire is shining a light on those living in the shadows of the state’s opioid epidemic: the children who live with their parents’ 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)
Cincinnati Enquirer:
Stepping Up The Fight: NKY Office Of Drug Policy Expands Board
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)
