DEA’s failure to punish distributor blamed in opioid crisis raises revolving door questions

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This article was published 24/05/2023 (1247 days ago), so information in it may no longer be current.

SHREVEPORT, La. (AP) — The U.S. Drug Enforcement Administration has allowed one of the nation’s largest wholesale drug distributors to keep shipping highly addictive painkillers for nearly four years after a judge recommended it be stripped of its license for its “cavalier disregard” of thousands of suspicious orders fueling the opioid crisis.

The DEA did not respond to repeated questions from The Associated Press about its handling of the case against Morris & Dickson Co. or the involvement of a high-profile consultant the company had hired to stave off punishment and who is now DEA Administrator Anne Milgram’s top deputy.

But the delay has raised concerns about how the revolving door between government and industry may be impacting the DEA’s mission to police drug companies blamed for tens of thousands of American overdose deaths.

“If the DEA had issued its order in a timely manner, one could then credibly believe that its second-in-command was not involved despite an obvious conflict of interest,” said Craig Holman, an ethics expert at the watchdog group Public Citizen in Washington. “The mere fact that its action has been delayed four years just raises red flags. It casts the entire process under grave suspicion.”

Last week, after the AP reached out to the DEA for comment, the agency broke its silence on the issue and abruptly notified Morris & Dickson that it has decided to revoke its registration to distribute controlled substances, according to two people familiar with the development who spoke on the condition of anonymity to discuss the exchange. However, no final order has yet been published. The company has described revocation as a “virtual death sentence” and is almost certain to challenge the decision in federal court.

Louis Milione, who was named DEA’s principal deputy administrator in 2021, did not respond to requests for comment. He retired from the DEA in 2017 after a storied 21-year career that included two years leading the division that controls the sale of highly addictive narcotics. Like dozens of colleagues in the DEA’s powerful-but-little-known Office of Diversion Control, he quickly went to work as a consultant for some of the same companies he had been tasked with regulating, including Morris & Dickson.

Milione was brought in by Morris & Dickson as part of a $3 million contract to save its registration to supply painkillers after the DEA accused the company in 2018 of failing to flag thousands of suspicious, high-volume orders.

Testifying in 2019 before federal Administrative Law Judge Charles W. Dorman, Milione argued that Morris & Dickson “spared no expense” to overhaul its compliance systems, cancel suspicious orders and send daily emails to the DEA spelling out its actions.

But those efforts were too little, too late, the judge wrote in a 159-page recommendation which has not been previously reported and was recently obtained by the AP. Anything less than the most severe punishment, he said, “would communicate to DEA registrants that despite their transgressions, no matter how egregious, they will get a mere slap on the wrist and a second chance so long as they acknowledge their sins and vow to sin no more.”

“Acceptance of responsibility and evidence of remediation are not get-out-of-jail-free cards that erase the harm caused by years of cavalier disregard,” Dorman wrote. “Allowing the respondent to keep its registration would tell distributors that it is acceptable to take a relaxed approach to DEA regulations until they are caught, at which point they only need to throw millions of dollars at the problem to make the DEA go away.”

Shreveport, Louisiana-based Morris & Dickson, the nation’s fourth-largest wholesale drug distributor with $4 billion a year in revenue and nearly 600 employees, has said losing its license would effectively shut it down and have a “catastrophic” effect on patients in 29 states.

In a statement to AP, the company said it has invested millions of dollars in compliance systems, executives and advisors. “If DEA attempts to revoke our license for previous actions, the company will vigorously appeal and seek a stay in federal court,” it said. “We are confident we will achieve an outcome that safeguards the supply chain for all of our healthcare partners and the communities they serve.”

Neither Milgram nor two DEA administrators who preceded her have taken any enforcement action since Dorman’s 2019 recommendation, allowing Morris & Dickson to continue operating even as it pursued a potential settlement. Former DEA officials told AP a nearly four-year wait in such a case is highly unusual, noting it rarely takes the agency more than two years to issue a final order.

Milgram’s management of DEA since the Biden nominee came into office nearly two years ago has been called into question on another front. AP reported last month that a federal watchdog is investigating whether the agency improperly awarded millions of dollars in no-bid contracts to hire Milgram’s past associates.

As for Milione, federal ethics rules bar government employees from taking part in decisions that could benefit companies where they previously worked. DEA spokesperson Christina Pryor declined to comment, but a person familiar with Milione’s work said he recused himself from issues related to Morris & Dickson after returning to the DEA in 2021. The person spoke on condition of anonymity because they were not authorized to speak publicly about DEA officials’ recusals.

Milione, a lawyer and former bit Hollywood actor, impressed fellow DEA agents for his risk taking and toughness. Among his achievements was running the overseas sting that in 2008 nabbed Russia’s notorious arms trafficker Viktor Bout, aka “The Merchant of Death.”

But after taking over as the head of Diversion Control in 2015, he ended his predecessor’s refusal to meet with drug manufacturers and distributors and opened the DEA’s doors to the industry it was charged with regulating.

Among those Milione met with on at least two occasions was Paul Dickson Sr. — then-president of Morris & Dickson. That included a 2016 visit to the Louisiana headquarters with DEA investigators to discuss the company’s compliance program.

John Gray, the head of the Healthcare Distributors Alliance, a lobbying group that includes Morris & Dickson, recounted in a 2015 email how Milione, under orders from then-incoming DEA Administrator Chuck Rosenberg, wanted to “reset” relations with the drug industry. And Milione even delivered the keynote speech at the group’s annual meeting.

“Overall, he was engaging, exceedingly pleasant and seemed genuinely concerned that we had lost touch with each other,” Gray wrote. “It is a very different tone and approach than we have all seen in the past 8-10 years.”

Morris & Dickson had been punished for its mishandling of addictive drugs before. In 2019, before Dorman issued his recommendation, the company agreed to pay $22 million in civil penalties to resolve federal prosecutors’ claims that it violated the Controlled Substances Act by failing to report suspicious orders of hydrocodone and oxycodone. The company also agreed to multimillion-dollar upgrades of its compliance program to ensure it reports suspicious orders moving forward.

The case drew far less attention than the enforcement actions DEA took in recent years against Morris & Dickson’s larger competitors, a trio of pharmaceutical distributors who have agreed to pay the federal government more than $1 billion in fines and penalties for similar violations. Cardinal Health, AmerisourceBergen and McKesson also agreed to pay $21 billion over 18 years to resolve claims as part of a nationwide settlement.

Among the more than 12,000 suspicious orders that Dorman said Morris & Dickson should have reported to the DEA were 51 unusually large orders of opioids made by Wilkinson Family Pharmacy in suburban New Orleans.

Wilkinson purchased more than 4.5 million pills of oxycodone and hydrocodone from Morris & Dickson between 2014 and 2017, and federal prosecutors say during that time owner Keith Wilkinson laundered more than $345,000 from illegal sales made with forged prescriptions or written by “pill mill” doctors.

In one month, as many as 42% of all prescriptions filled by Wilkinson were for painkillers and 38% of those were paid for in cash. The DEA considers a pharmacy’s sales of controlled substances suspicious whenever they surpass 15% or cash transactions exceed 9%.

Yet Morris & Dickson never suspended any shipments to the pharmacy. Over three years, it filed just three suspicious order reports to the DEA – none of which resulted in shipments being suspended.

“Anybody with half a brain could’ve seen something wasn’t right,” said Dan Schneider, a retired pharmacist near New Orleans whose fight to hold drug companies accountable for the opioid epidemic was featured in a Netflix documentary series. “They were way out of line.”

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Goodman reported from Miami. Contact AP’s global investigative team at Investigative@ap.org.