FDA Inaction On Deadly Opioids ‘Borders On Criminal,’ Charges Head Of Advisory Panel

The head of a Food and Drug Administration advisory panel on opioids has accused the federal agency of looking out for pharmaceutical company income at the tragic cost of public lives, saying the behavior “borders on the criminal.”

“As I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything,” Dr. Raeford Brown told The Guardian earlier this week. “The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”

He said the FDA talks a “good game, then nothing happens.”

Brown’s angry attack comes as the Massachusetts attorney general is suing Purdue Pharma and members of the Sackler family who own the company that manufactures OxyContin, accusing them of being “personally responsible” for a “deceptive sales tactics” that pumped their highly addictive drug into public hands.

Almost 400,000 people died from opioid overdoses between 1999 and 2017, according to statistics from the federal Centers for Disease Control. Some 47,000 people died of opioid overdoses in 2017, and 36 percent of those were attributed to prescription drugs. 

The Sackler family pushed doctors to get “more patients on opioids, at higher doses, for longer, than ever before” while paying “themselves billions of dollars,” Massachusetts Attorney General Maura Healey told CBS This Morning on Thursday.

“They don’t want to accept blame for this. They blame doctors, they blame prescribers and worst of all, they blame patients,” Healey added.

Even as company managers were aware of how powerfully addictive their product was, former company president Richard Sackler urged pushing the blame for overdose deaths on the victims, according to Healey.

“We have to hammer on the abusers in every way possible,” Sackler wrote in an 2001 email revealed in the lawsuit. “They are the culprits and the problem. They are reckless criminals.”

In a lengthy statement to CBS, Purdue Pharma called the accusations “a rush to vilify” the drugmaker, and accused the lawsuit of “cherry-picking” emails. The company claims Healey’s complaint “irresponsibly … casts every prescription of OxyContin as dangerous and illegitimate, substituting its lawyers’ sensational allegations for the expert scientific determinations of the … FDA.”

Massachusetts is one of at least 30 states suing Purdue Pharma, accusing the company of hiding OxyContin dangers. The company admitted to falsely selling the drug as “less addictive” than rival products in a 2007 federal settlement and paid $630 million in fines.

Brown harshly criticized the FDA’s recent approval of the new opioid Dsuvia, manufactured by AcelRx.

Four US senators wrote to the head of the FDA late last year urging him to block the sale of Dsuvia, a synthetic opioid ten times more potent than fentanyl, because of concerns about public health. An advisory committee rejected the drug in 2017 over safety concerns. 

The FDA should “stop considering any new opioid evaluation,” Brown told The Guardian. “For every day and every week and every month that the FDA [doesn’t] do the right thing, people drop dead on the streets.” 

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