Opioids allocated based on business decision

‘Business decision’: Former DEA official works for opioid lawyers but set standards for how many pills were made – By John O’Brien | Sep 3, 2019

The DEA knew more about what quantities of opioids went where than anyone else, so I’m baffled why they didn’t stop the excessive orders that everyone is complaining about now.

Asked what would’ve happened if a pharmaceutical distributor wanted advice on whether a large order of opioids was suspicious, the man in charge of federal regulation of those pills for 10 years said he wouldn’t have helped.

Instead, Joe Rannazzisi, who set always-increasing opioid quotas for theindustry while he headed a Drug Enforcement Agency department from 2005-15, said the company would be left on its own to figure it out.   

“So if a distributor came to you in (2007-2010) and said, ‘We… can’t tell if this order is legitimate or suspicious,’ DEA would refuse to answer?” he was asked at a deposition this year.

“It’s DEA’s policy that they do not advise when to ship or when to file a suspicious orders. That’s a business decision that, under the regulations, is maintained by the distributor,” Rannazzisi said.

This is about half true. The DEA allocates quotas of opioids to the manufacturers of opioid medications, who then send them to distributors, who ship them to pharmacies.

There could be, and probably are, several other businesses involved in these main steps (like shipping companies, warehousing companies, administrative companies, etc.). These businesses insert themselves into the supply chains between the original producers and their end customers, and profit by diverting some of the money into their own coffers.

Now, Rannazzisi is helping private lawyers pin the blame squarely on manufacturers and distributors of opioids, as well as pharmacies

A post-DEA alliance with trial lawyers has been worth six figures for Rannazzisi, who has been hailed as a whistleblower by those cheering attempts to prosecute the opioid industry for the nation’s addiction crisis.

Rannazzisi has admitted he is consulting for plaintiffs lawyers who are chasing their shares of possibly billions of dollars in fees. Details emerged this year at a deposition in the federal opioid multidistrict litigation, which consists of nearly 2,000 lawsuits brought by cities, counties and American Indian tribes, as well as other entities.

Lawyers for the companies being sued challenged his actions while in office pointing out the dramatic increases in quotas for painkillers set by the DEA and its unwillingness to help companies that sought advice on whether an order was suspicious.

A popular defense is that the dispersal of opioids was regulated and federal officials approved what was happening. The combined quotas for oxycodone and hydrocodone nearly tripled from 2005-2015, when Rannazzisi was director of the DEA’s Office of Diversion Control.

The ODC increased the number of registrants allowed to prescribe and dispense opioids to more than 1.6 million under Rannazzisi, an increase of 45%. At the same time, the ODC took in registration fees that helped fund the department’s $300 million budget while more than 176,000 Americans died from their addiction.

Once the DEA sets quotas, it allocates a portion of them to the registered companies.

Also at its disposal to track where opioids are going is a database called ARCOS which, Rannazzisi testified in 2007, was being used to identify excessive volume purchases.

As to the rise in quotas, defense attorneys pointed out that in the year Rannazzisi took office, the quota for hydrocodone was 37,604 kilograms. In his last year, Rannazzisi helped set the quota at 99,625 kilograms.

For oxycodone, the 2005 quota was 50,490 kgs. By 2015, it was 137,500 kgs.

Rannazzisi shifted the blame for not flagging suspicious orders to the companies he was monitoring.

He was clearly not doing the job he was supposed to. I’d love to see the DEA’s own job description for the “Director of the DEA’s Office of Diversion Control” because I wonder if he perhaps was not officially responsible for monitoring the flow of opioid medications shipped by the distributers.

“And it was DEA’s policy not to tell registrants than an order is or is not suspicious, correct,” he was asked.

“Well, that’s a business decision that only the… distributor could make.

So he claims the DEA only sets quotas and then does nothing else to monitor where they end up. That’s what allowed massive diversion from the supply chain. They insist this didn’t happen, but I expect we’ll eventually find out that the opioids were only controlled at the individual patient end of the chain.

Grandma’s medicine cabinet, faked pain in patients, and individual counterfeit prescriptions aren’t nearly enough to account for the millions of pills that were available on the black market in the late ’90s and early 2000s.

They’re the only ones who know their customer. And they know what their customers are doing. And they know the… population around the customer’s business. They know what is in the area that could warrant an increase or not.

Asked why the DEA didn’t tell registrants to stop sales, he said there were “due process concerns.”

Interesting how the DEA only has “due process concerns”  when working with massive amounts of opioids, yet tramples all over “due process” in going after legitimate doctors of patients with legitimate pain.