Thursday, October 24

Drugs flowed for years as DEA dragged ft on disciplining opioid distributor

SHREVEPORT, La. (AP) — The U.S. Drug Enforcement Administration has allowed one of many nation’s largest wholesale drug distributors to maintain delivery extremely addictive painkillers for almost 4 years after a choose really useful it’s stripped of its license for its “cavalier disregard” of hundreds of suspicious orders fueling the opioid disaster.

The DEA didn’t reply to repeated questions from The Associated Press about its dealing with of the case in opposition to Morris & Dickson Co. or the involvement of a high-profile marketing consultant the corporate had employed to stave off punishment and who’s now DEA Administrator Anne Milgram’s prime deputy.

But the delay has raised issues about how the revolving door between authorities and trade could also be impacting the DEA’s mission to police drug corporations blamed for tens of hundreds 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,” stated Craig Holman, an ethics skilled on 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 remark, the company broke its silence on the difficulty and abruptly notified Morris & Dickson that it has determined to revoke its registration to distribute managed substances, in keeping with two folks accustomed to the event who spoke on the situation of anonymity to debate the trade. However, no last order has but been revealed. The firm has described revocation as a “virtual death sentence” and is sort of sure to problem the choice in federal courtroom.

Louis Milione, who was named DEA’s principal deputy administrator in 2021, didn’t reply to requests for remark. He retired from the DEA in 2017 after a storied 21-year profession that included two years main the division that controls the sale of extremely addictive narcotics. Like dozens of colleagues within the DEA’s powerful-but-little-known Office of Diversion Control, he shortly went to work as a marketing consultant for a few of the identical corporations he had been tasked with regulating, together with Morris & Dickson.

Milione was introduced in by Morris & Dickson as a part of a $3 million contract to save lots of its registration to provide painkillers after the DEA accused the corporate in 2018 of failing to flag hundreds of suspicious, high-volume orders.

Testifying in 2019 earlier than federal Administrative Law Judge Charles W. Dorman, Milione argued that Morris & Dickson “spared no expense” to overtake its compliance methods, cancel suspicious orders and ship day by day emails to the DEA spelling out its actions.

But these efforts have been too little, too late, the choose wrote in a 159-page suggestion which has not been beforehand reported and was lately obtained by the AP. Anything lower than probably the most extreme punishment, he stated, “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 yr in income and almost 600 workers, didn’t reply to requests for remark. But the corporate repeatedly stated in courtroom filings that shedding its license would successfully shut it down and have a “catastrophic” impact on sufferers in 29 states.

Neither Milgram nor two DEA directors who preceded her have taken any enforcement motion since Dorman’s 2019 suggestion, permitting Morris & Dickson to proceed working even because it pursued a possible settlement. Former DEA officers informed AP an almost four-year wait in such a case is very uncommon, noting it not often takes the company greater than two years to problem a last order.

Milgram’s administration of DEA has been referred to as into query on one other entrance. AP reported final month {that a} federal watchdog is investigating whether or not the company improperly awarded tens of millions of {dollars} in no-bid contracts to rent Milgram’s previous associates.

As for Milione, federal ethics guidelines bar authorities workers from collaborating in selections that would profit corporations the place they beforehand labored, however DEA didn’t reply to questions on whether or not Milione recused himself from the matter. He would have additionally confronted restrictions on his interactions with the DEA when he left authorities as a senior official – a problem the company’s personal attorneys raised in an try to disqualify his testimony in help of Morris & Dickson.

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

But after taking up as the top of Diversion Control in 2015, he ended his predecessor’s refusal to satisfy with drug producers and distributors and opened the DEA’s doorways to the trade it was charged with regulating.

Among these Milione met with on no less than two events was Paul Dickson Sr. – then-president of Morris & Dickson. That included a 2016 go to to the Louisiana headquarters with DEA investigators to debate the corporate’s compliance program.

John Gray, the top of the Healthcare Distributors Alliance, a lobbying group that features Morris & Dickson, recounted in a 2015 e-mail how Milione, below orders from then-incoming DEA Administrator Chuck Rosenberg, wished to “reset” relations with the drug trade. And Milione even delivered the keynote speech on the group’s annual assembly.

“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 medicine earlier than. In 2019, earlier than Dorman issued his suggestion, the corporate 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 firm additionally agreed to multimillion-dollar upgrades of its compliance program to make sure it stories suspicious orders transferring ahead.

The case drew far much less consideration than the enforcement actions DEA took lately in opposition to Morris & Dickson’s bigger opponents, a trio of pharmaceutical distributors who’ve agreed to pay the federal authorities greater than $1 billion in fines and penalties for comparable violations. Cardinal Health, AmerisourceBergen and McKesson additionally agreed to pay $21 billion over 18 years to resolve claims as a part of a nationwide settlement.

Among the greater than 12,000 suspicious orders that Dorman stated Morris & Dickson ought to have reported to the DEA have been 51 unusually giant orders of opioids made by Wilkinson Family Pharmacy in suburban New Orleans.

Wilkinson bought greater than 4.5 million drugs of oxycodone and hydrocodone from Morris & Dickson between 2014 and 2017, and federal prosecutors say throughout that point proprietor Keith Wilkinson laundered greater than $345,000 from unlawful gross sales made with cast prescriptions or written by “pill mill” docs.

In one month, as many as 42% of all prescriptions crammed by Wilkinson have been for painkillers and 38% of these have been paid for in money. The DEA considers a pharmacy’s gross sales of managed substances suspicious every time they surpass 15% or money transactions exceed 9%.

Yet Morris & Dickson by no means suspended any shipments to the pharmacy. Over three years, it filed simply three suspicious order stories to the DEA – none of which resulted in shipments being suspended.

“Anybody with half a brain could’ve seen something wasn’t right,” stated Dan Schneider, a retired pharmacist close to New Orleans whose struggle to carry drug corporations accountable for the opioid epidemic was featured in a Netflix documentary sequence. “They were way out of line.”

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Goodman reported from Miami.

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