Uncovering Black Market Opioid Abuse In Florida, Around the Country, And How to Monitor

500 million. That is the number of oxycodon (a highly addictive, opioid painkiller) pills that ended up in Florida between 2008 and 2012 — 66 percent of all oxycodone sold in the state. After oxycodone manufacturers (Mallinckrodt) failed to abide by laws designed to prevent legal narcotics on the black market, Government investigators alleged that the company’s lack of due diligence could have resulted in nearly 44,000 federal violations and exposed it to $2.3 billion in fines during that four-year period. 

But still, nearly six years later, the government has failed to take any legal action against Mallinckrodt. Instead, the company reached a settlement with prosecutors, agreeing to pay a $35 million fine and admit no wrongdoing. 

So what about the opioid problem within the black market? Does it just disappear?

This case shows that it's difficult for the government to hold a drug manufacturer responsible for damage caused by its product. 

According to an article by The Washington Post, “They [Mallinckrodt] just weren’t taking this seriously, and people were dying,” said a former law enforcement official who spoke on the condition of anonymity because the case is pending. “People were dying all over the place. It wasn’t their kids, their wives, their husbands, their brothers. It was some hillbilly in Central Florida, so who cares?” Mallinckrodt has outright denied these claims, saying that they work hard to fight drug diversion. 

Drug manufacturers are required to notify the DEA immediately when suspicious orders occur.
Mallinckrodt has allegedly acknowledged its responsibility to report suspicious activity,  but the company does not believe it should not be held responsible for what happens to its drugs once distributors send them to customers.

So, again, we ask where this leaves us.

Nearly 180,000 opioid deaths have occurred since 2000.

Prosecutors say they considered 43,991 orders from distributors and retailers to be suspicious from 2008-2012 — orders that Mallinckrodt should have reported to the DEA. But the company said it was impossible to monitor all of the 55,000 retail outlets where its drugs are delivered.

This year, Mallinckrodt reached a $35 million settlement case with the DEA and federal prosecutors. And, in retrospect, drug manufacturers have paid much larger fines for other misdeeds. 

According to the Washington Post article, Glaxo­SmithKline was fined $3 billion, and Pfizer was fined $2.3 billion for illegally promoting off-label drug use and paying kickbacks to doctors. Purdue Pharma paid a $600 million fine, and three of its executives pleaded guilty to charges that they misled regulators, doctors and patients about the risks of the painkiller that is widely blamed for setting off the nation’s opioid crisis: OxyContin. All of those cases were initiated by the Food and Drug Administration.

The largest fine clocks in at $150 million. 

But money isn't the issue. What the issue is here is that drug monitoring by manufacturers, and the DEA monitoring those manufacturers, is new ground. The DEA is now putting a new necessity on keeping manufacturers up to par. It's about holding a manufacturer accountable and putting the industry on notice. 

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