U.S. Sen. Claire McCaskill said Wednesday that a new report shows that the U.S. Drug Enforcement Administration failed to hold major drug distributors accountable as prescription opioids poured into Missouri from 2012 to 2017.
McCaskill’s office compiled the report because she is the top Democrat on the U.S. Senate Homeland Security and Governmental Affairs Committee. The report shows that the three top opioid distributors reported wildly different numbers of suspicious shipments to the DEA, and the federal agency didn’t use its most potent enforcement tool — the immediate suspension order — to stop distributors from making questionable shipments.
“What the report finds very clearly is something is wrong with the application of the law as it relates to reporting potential problematic distributions,” said McCaskill. “Because clearly the law is not being applied the same way among these three major distributors, and it calls into question how effective the DEA is being in terms of overseeing the distribution of opioids in this country. ”
DEA spokesman Rusty Payne said the agency has initiated about 1,500 cases and made about 2,000 arrests a year over the last seven years. It also ramped up its drug diversion squads from 46 in 2012 to 77 today to address the opioid crisis.
“This is a huge part of what we’re doing right now,” Payne said.
But McCaskill’s report suggests the agency has come down harder on smaller players like doctors and pharmacies than it did on the major drug distributors that shipped them prescription opioids.
The report says McKesson, Cardinal Health and AmerisourceBergen, the three giants of the pharmaceutical drug distribution industry, shipped 1.6 billion doses of opioids to Missouri from 2012 to 2017. That works out to 260 doses for each person in the state.
Some of those drugs were stolen, diverted or sold to people who weren’t medically supposed to be using them, helping fuel an opioid epidemic that causes hundreds of deaths a year and has increased overdose-related trips to Missouri emergency rooms by more than 20 percent.
Disciplinary orders from the Missouri Board of Pharmacy show that employees at Walgreens and CVS locations in Kansas City and Independence were caught stealing tens of thousands of opioid pills for personal use or to sell on the black market.
Under federal law, drug distributors are required to report to the DEA orders of controlled substances that are suspicious because of their size or frequency, or just because they’re out of the ordinary for that particular pharmacy. But the three biggest distributors had very different records of doing that in Missouri during those years.
AmerisourceBergen and McKesson shipped about the same number of opioid dosage units to Missouri during those years, but AmerisourceBergen told the committee it made 224 suspicious order reports related to those shipments to the DEA, while McKesson made 16,714 reports. Cardinal Health, which shipped about half as many units to Missouri as the other two, made 5,125 reports.
“Someone is doing this wrong,” McCaskill said, “and the fact that we had to uncover this as part of an investigation and the DEA is not on top of this and doesn’t have a good explanation for it is really concerning.”
Payne said he wouldn’t want to speculate on the reasons for the discrepancies but noted that the DEA has sanctioned all three distributors in the past for failing to stem suspicious opioid shipments, including a record $150 million settlement with McKesson last year.
McCaskill’s report stresses that the disparities in reporting don’t necessarily mean that any of the companies are breaking the law.
An AmerisourceBergen representative released a statement that says the company uses a more targeted, two-step process that includes having humans investigate all potentially suspicious orders that are flagged by a computer program.
“We believe this process makes our suspicious order reports to the DEA highly precise and actionable,” the statement said. “Other distributors may take a different approach — for example, simply reporting as suspicious all orders flagged by the system.”
The Healthcare Distribution Alliance, a trade association for drug distributors, told the Senate committee that the DEA had not provided clear enough information about what constituted a suspicious order to get consistent reporting across companies.
But Joseph Rannazzisi, the former head of the DEA Office of Diversion Control, disputed that, telling McCaskill’s office that since 2006, the agency had gone to great lengths to explain to drug distributors what their reporting obligations were under the law.
“We showed them what a suspicious order is,” the committee report quotes Rannazzisi as saying. “We showed them why it was suspicious. We showed ordering patterns that showed that they were doing something that they probably should not be doing.”
McCaskill’s report cites a 2016 Washington Post investigation that quoted Rannazzisi and other former DEA officials saying that drug distributors knew or should have known that some of the opioids they were shipping were being diverted for nefarious purposes.
The report says the DEA has focused on using fines and investigations that lead distributors to voluntarily agree to surrender their controlled substance licenses.
But even the biggest fines are a small fraction of the annual revenue for a company like McKesson, which took in almost $200 billion last year, and the 22 voluntary surrenders the agency secured against drug distributors from 2012 to 2017 were all from smaller, regional companies.
McCaskill said issuing immediate suspension orders would be a more effective deterrent.
Payne said those orders are rare because they have “a much higher bar to clear” than other enforcement actions.
But McCaskill’s report cites former DEA officials who gave other reasons. They said the “revolving door” of employees moving back and forth between the agency and the drug distribution industry produced conflicting loyalties, and the prospect of going up against well-heeled corporate law firms intimidated DEA lawyers.
“According to a former assistant special agent in charge of the DEA Denver field division,” the report says, “DEA attorneys would frequently ask, ‘Why would you go after a Fortune 50 company that’s going to cause all these problems with Ivy League attorneys, when we can go after other (DEA registrants) that are much lower, that are going to put up no fight?’ ”