In two separate hearings, lawmakers heard testimony from the acting DEA Administrator Robert Patterson and the heads of the country’s largest opioid manufacturers as they assessed the failures that led to the drug crisis and what is being done to stop it.
Prescription opioid abuse is currently the most common form of drug abuse in the country, with the exception of marijuana. The DEA reported nearly 3.4 million Americans had abused prescription pain pills in 2016.
In recent years, the number of deaths associated with prescription drugs has declined as a percentage of the more than 40,000 opioid-related overdose deaths. In part, the decline is related to stricter DEA quotas on manufacturers, the Justice Department crackdown on so-called pill mills and improved methods of tracking drug by the companies themselves.
Despite some gains, Patterson argued companies must be held “more accountable” for failing to stop the illegal diversion of prescription drugs.
“They’re aware of the problems. They’ve been aware of the problems,” he said, noting some companies have evaded DEA regulations for more than a decade. “Frankly, we have done a lot of civil fines, but when you look at major businesses, civil fines seem to have little impact. I think that’s part of the frustration.”
Under the law, companies have a duty to investigate, report and in some cases stop the shipment of suspiciously large or frequent drug orders. For years, top opioid manufacturers and distributors neglected obvious red flags and faced minimal consequences, including letters from DEA and fines.
In the case of McKesson Corp., the countries largest drug distributor, they paid a $13.25 million fine in 2008 for failing to detect and report suspicious orders for opioids. In 2017, they faced similar allegations and $150 million in fines. The company earned more than $48 billion that year.
Similarly, Cardinal Health paid out a $44 million settlement in 2017 for failing to notify the DEA of suspicious orders. The company paid $34 million in 2008 in a nearly identical settlement.
For the large drug companies, civil fines have “unfortunately become the price of doing business,” Patterson said.
The Department of Justice may soon shift away from the slap on the wrist approach, the administrator continued, saying there is a “change in the philosophy in the prosecutors’ offices and with DEA that we need to hold people more accountable than just a civil fine.”
DRUG EXECS DENY FUELING OPIOID CRISIS
As Patterson called for a tougher approach to drug companies, members of a House Energy and Commerce subcommittee pressed current and former executives for McKesson, Cardinal Health, AmerisourceBergen, Miami-Luken and H.D. Smith, asking them to account for their role in the opioid epidemic.
The five companies are responsible for the majority of prescription opioid manufacturing and distribution in the United States. Together, they have paid billions of dollars in fines and legal settlements and continue to face questions about their responsibility for an epidemic that has killed tens of thousands of people.
On Tuesday, Rep. Gregg Harper, R-Miss., chairman of the subcommittee, asked each CEO whether his company contributed to the country’s opioid epidemic. All said no, with the exception of Dr. Joseph Mastandrea, CEO of the regional distributor Miami-Luken.
Asked if their companies failed to maintain “effective controls to prevent the diversion of opioids” in the past, only Mastandrea answered in the affirmative. The other executives effectively claimed they acted “effectively and responsibly” and “satisfied” their duties to control the drug supply and report suspicious orders.
The CEOs were brought before the committee on the one-year anniversary of an investigation of prescription pain pill “dumping” in small towns in West Virginia, the state with the highest rate of opioid overdose deaths.
In Kermit, a town of 400 people, one pharmacy received more than 9 million pills in the span of two years. In Williamson, with a population of approximately 3,200, two pharmacies less than four blocks apart distributed a shocking 20.8 million painkillers over 10 years.
The heads of McKesson and Cardinal Health, who facilitated the shipment of tens of millions of pills to West Virginia, apologized for failing to take action sooner, though they did eventually cut off shipments to pill mill pharmacies.
West Virginia Republican Rep. David McKinley lashed out at the pharmaceutical executives blaming them for “the scourge” of the opioid epidemic.
“What’s the punishment that fits this crime when 900 people in West Virginia lose their life…just a slap on the wrists, a financial penalty, or should there be time spent for participating in this?” the congressman asked.
Filled with emotion, McKinley told the CEOs, “I just want you to feel shame about your roles respectively in all of this.”
Each of the companies present at the Tuesday hearing is currently a defendant in at least one lawsuit related to the opioid crisis. Many of the suits allege the companies not only bear responsibility for the opioid epidemic but profited from it.
States, cities and the federal government have brought hundreds of lawsuits against drug manufacturers and distributors seeking compensation for the costly and deadly drug crisis. Cardinal Health alone was named in more than 350 lawsuits.
TACKLING THE PROBLEM
Congress, individual states and the Department of Justice are clearly setting their sites on the drug companies, looking back at the role they played in driving the epidemic. DEA administrator Patterson said his agency is looking ahead at ways to combat the crisis, starting by reducing demand for the drugs by doctors and pharmacies.
“We have to change the culture in this country,” Patterson told lawmakers. “Where this has to change is in the prescribing practices… This is really where the rubber meets the road.”
In recent months, the DEA and Department of Justice surged enforcement resources to crack down on doctors, pharmacies and distributors illegally diverting opioids. At the beginning of April, the effort led to the arrests of 28 drug prescribers and pharmacists and 147 people lost their licenses to handle controlled substances.
The DEA also hopes to curb prescription opioid abuse by linking up statewide prescription drug monitoring programs. These state-run electronic databases are used by doctors, pharmacists and law enforcement to track controlled substances, prevent dangerous overprescribing and stop patients from “doctor shopping.”
All 50 states have prescription monitoring programs, but they generally don’t coordinate across state lines. This is a “highly problematic” issue in stopping illicit diversions of prescription opioids, Patterson warned.
He suggested Congress draft legislation creating a national database where doctors, pharmacists and law enforcement officials can view information from other states. “It shouldn’t be too complicated and it’s absolutely necessary,” he said.
In its findings, the White House opioid commission explained how America’s current drug problem started not on street corners, but in doctors’ offices. One of the challenges the DEA is facing is the transition from licit drugs, like hydrocodone, OxyContin and others to increasingly potent and deadly street drugs, like heroin and fentanyl.
“This trend has changed over the last couple of years,” Patterson said. “As we see the licit market, the pharmaceutical market continues to come down, it creates a natural void.” That void is being filled criminal organizations trafficking heroin and synthetic opioids like fentanyl.
That transition away from pharmaceuticals to highly potent fentanyl, sometimes pressed into pills that resemble prescription drugs, has contributed to the continuing rise in opioid overdose deaths. In 2016, nearly 20,000 deaths were linked to fentanyl and other synthetic opioids.
DEA and its partners across the government are working to stop the shipment of fentanyl and chemical precursors into the United States through the postal service and across the southern and northern borders.
While the agency coordinates enforcement efforts and tackles the downstream effects of the opioid epidemic, Patterson emphasized that addressing demand is the critical component to tackling America’s addiction crisis.
“Ultimately, to fundamentally change this epidemic, we must decrease demand for these substances working collaboratively on all fronts,” he said.
