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Opioid distribution companies and a retired DEA official blamed each other during a Charleston trial on Wednesday, saying their counterparts were unclear in communication, which fueled the crisis in opioids in the Appalachians.
Joe Rannazzisi, head of the Drug Enforcement Administration’s Diversion Control Office from 2006 to 2015, and the distributors argued that the other party ignored requests for regulatory and policy compliance, which would have was able to guide them in stopping the illegal diversion of opioid pills. as they poured into local communities.
Paul Schmidt, an attorney for McKesson, said distributors had been working with a similar policy system for 35 years, but when Rannazzisi took office he made a series of drastic changes. He said the defendants had worked tirelessly to change his policies and programs for monitoring suspicious orders following meetings with the DEA, but efforts to satisfy Rannazzisi failed because he was not clear in his statements. .
Rannazzisi said it was the distributors who failed to follow DEA policies, leading to several immediate stay orders and significant monetary settlements with several distribution centers run by the defendants.
The testimony is heard in a lawsuit in which Cabell and Huntington County accuse the big three drug wholesalers AmerisourceBergen, Cardinal Health and McKesson of fueling the opioid crisis by sending excessive shipments of opioids to the region for eight Years before a reduction in the number of pills shipped caused users to turn to illegal drugs.
The defendants point to the DEA, the doctors and the ill health of West Virginia as the culprits.
The changes made during Rannazzisis’s reign were commemorated in a series of letters sent by Rannazzisi from 2006, which were sent to distributors. Rannazzisi said the purpose of the letters was to reiterate that distributors have a duty to exercise due diligence to avoid filling suspicious orders that could be diverted to the illicit market.
But the focus didn’t end there, he said, as the DEA held several meetings and seminars with distributors to help them understand.
Perhaps the most crucial point the defendants attempted to make with Rannazzisis’s testimony was to highlight the rulings written by senior DEA members and federal judges who referred to the letters.
Schmidt attempted to use Rannazzisi’s own words against him when discussing a 2006 Congressional hearing in which he testified that the vast majority of prescribers act legally with their prescribing habits. He said doctors shouldn’t hesitate to prescribe opioids for legitimate reasons.
Schmidt said distributors follow DEA quotas set each year based on the number of prescriptions doctors make.
He referred to a letter from Rannazzisi sent to distributors in 2006 that the DEA recognized that the overwhelming majority of distributors are acting legally.
A review of AED regulatory and enforcement efforts, released by the Office of the Inspector General in 2019, found that the DEA enrollee population was growing on average by about 40,000 enrollees per year, but the DEA enforcement personnel did not increase at the same rate. From 2007 to 2017, the registrant population increased by 30%, but the staff of diversion investigators only increased by 20%.
In 2016, West Virginia led the country in opioid-related overdose deaths (43.4 deaths per 100,000 people), with the majority attributed to oxy- and hydrocodone, as well as to heroine, according to the report. The DEA increased the number of registrants in the state during this period.
The Office of the Inspector General opened an investigation into Rannazzisi after two House Republicans accused him of intimidation after he left the DEA, but he never received a letter of exemption in this case, Schmidt said, later adding that Rannazzisi had received $ 860,000 since 2017 for his work in the opioid litigation with the plaintiffs.
Schmidt also referred to a memo by Chuck Rosenberg, acting DEA administrator, presented in a case with Masters Pharmaceuticals in 2015, in which he mentioned the letters from Rannazzisis and worried about them, stating that the letters no. were not binding on the agency.
Rannazzisi said that at the time the letters were issued, the directors had no issues with them.
Schmidt said that in another case, a Michigan federal judge issued an opinion referring to the letters from Rannazzisis, stating that the DEA was seeking to expand the obligations of drug wholesalers through its policy changes, but that it did not there had never been any changes to the law or regulations.
The regulations state that an order is suspect if it is of an unusual size or frequency or if it has deviated from its normal course. Schmidt said there was no other language explaining how something could fit those criteria and the letters from Rannazzisis failed to do so. Schmidt said that prior to 2008 distributors shipped suspicious orders and reported them to the DEA and the DEA never took any action or attempted to change them until Rannazzisi took office.
Schmidt said the DEA had accepted reports of excessive orders for years before Rannazzisi took office. The drug diversion policy before Rannazzisi had explained that suppliers could determine if orders were excessive by checking their own sales and setting a cutoff. Anything beyond that was to be considered suspicious.
It was updated in 2009 to indicate that a suspicious order was an order that the registrant considered suspicious and had not fulfilled, but reported it to their local AED. He added that excessive purchase reports were no longer acceptable.
Between October 10 and October 21, 2005, McKesson shipped over 1.5 million dosage units of hydrocodone to six pharmacies, which Rannazzisi denounced on Tuesday. Rannazzisi was informed by McKesson that his system for monitoring suspicious orders had not recovered any generic drugs of the hydrocodone class. Rannazzisi called this a systemic failure.
Schmidt said they were flagged through over-ordering reports, but Rannazzisi said the over-ordering reports that defendants sent to DEA field officers each month contained hundreds of lines of reports. transaction and were confused and vague. They were also sent a month after this happened.
While Rannazzisi said he never knew what the over-ordering reports were supposed to say, Schmidt mentioned one that said it was sent because it reflected transactions crossing the threshold.
This is not a suspicious order, he said. You need a summary of how suspicious that is, not that it was just above the threshold. We need more details.
Rannazzisi said the DEA is investigating the facts, not the quantities.
Schmidt said it was never clear from the letters that the DEA wanted accounts or a description of what was suspicious. He said a letter from 2007 said they had to say an order qualified as suspicious, but not why.
In 2011 and 2013, the defendants’ trade association contacted the DEA seeking advice and information to help build their relationship, but their efforts were ignored. Rannazzisi said individual distributors have the right to seek advice, but not its advocacy group, the Healthcare Distributor Alliance.
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