Investigative journalists at the Washington Post reported that there was a sharp drop in the number of federal enforcement actions against large pharmaceutical distributors and others involved with prescription opioids, during a time when deaths from prescription opioids were continuing to rise in number.1

The articles, by a reporting team that includes Pulitzer Prize-winner Scott Higham and medical reporter Lenny Bernstein, led to an inquiry by US Senators Patrick J. Leahy (D-Vermont) and Ron Wyden (D-Oregon). Leahy and Wyden requested information about cases investigated by the US Drug Enforcement Agency (DEA) Diversion Control Division since 2011, when enforcement actions were carried out in 131 cases. By 2014, the number of enforcement actions plummeted to 40 cases.2

The newspaper's sources included 5 former DEA supervisors who said they were "alarmed and frustrated by the sharp drop in enforcement actions. The supervisors' concerns were echoed in reports filed by the DEA's chief administrative law judge that were obtained by the Post under the Freedom of Information Act."2

The DEA is part of the Department of Justice (DOJ), which has been led by US Attorney General Loretta Lynch since 2015. The slowdown in enforcement began before she was appointed. In a letter to Attorney General Lynch, available on the Washington Post website, the senators wrote:

"According to the Post, the judge who reviewed the diversion office's administrative caseload noted that civil case filings against distributors, manufacturers, pharmacies, and doctors plummeted from 131 in fiscal year 2011 to 40 in fiscal year 2014. The number of immediate suspension orders (ISOs) during the same period dropped from 65 to 9."3

The letter continued, "The Post also reported a troubling allegation that wholesale drug distributors were going around the Office of Diversion Control and pressing higher level officials within the Justice Department in an effort to reach favorable resolutions to pending investigations."

The letter in particular names and asks for information about cases involving Cardinal Health, Gulf Coast Medical Pharmacy, McKesson Corporation, Amerisource-Bergen, and Cardinal Health.

The senators requested documents and specific questions about a $150 million settlement between the Department of Justice and McKesson, which was reported in the Post articles.

Among the other direct questions in the letter are:

* "What factors have led to the decline in the use of orders to show cause and ISOs? Please describe any changes in policy or guidance that may have affected the use of these authorities."

* A request for an accounting for each year since 2011 of criminal enforcement actions, orders to show cause and ISOs that resulted in the suspension of registration.

* All investigations opened and closed by the Office of Diversion Control.3

"This startling decrease in enforcement activity occurred just as our nation began to confront the scope of the opioid epidemic - and just as the over-prescription of powerful opioid painkillers was recognized as a major driver of the crisis," the senators wrote.

In putting the opioid crisis in context, the senators wrote, "According to the Centers for Disease Control and Prevention, sales of opioid painkillers nearly quadrupled between 1999 and 2014, despite Americans not reporting an overall increase in their amount of pain. Nearly 250 million prescriptions are now written for opioid painkillers each year, more than one for every adult in the country. The National Institute on Drug Abuse reports that nearly 80 percent of heroin users reported using prescription painkillers before they began using heroin."

The series by the Post writers also included a piece on how opioid prescription drugs have been diverted. The article described how the intermediaries-wholesale drug distributors-include companies that followed the rules, as well as some that did not.

An excerpt from the Post article4 follows:

Collectively, 13 companies identified by The Washington Post knew or should have known that hundreds of millions of pills were ending up on the black market, according to court records, DEA documents and legal settlements in administrative cases, many of which are being reported here for the first time. Even when they were alerted to suspicious pain clinics or pharmacies by the DEA and their own employees, some distributors ignored the warnings and continued to send drugs.

"Through the whole supply chain, I would venture to say no one was doing their job," said Joseph T. Rannazzisi, former head of the DEA's Office of Diversion Control, who led the effort against distributors from 2005 until shortly before his retirement in 2015. "And because no one was doing their job, it just perpetuated the problem. Corporate America let their profits get in the way of public health."4

In addition to the companies named in the Leahy-Wyden letter, the 13 companies named by the Post series included Miami-Luken, KeySource Medical, and Walgreens.

The Post reported that although most of the wholesalers involved declined to be interviewed, court filings and congressional testimony from these companies in the past included complaints that it is difficult for them to police drug dispensers; and that "drugs could not be sold to illegal users without prescriptions written by corrupt doctors."

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