-- WaPo’s Scott Higham and Lenny Bernstein partnered with "60 Minutes” to investigate how Congress in 2016 weakened the DEA’s ability to go after drug distributors — thanks largely to a massive targeted lobbying effort at the peak of America’s opioid crisis.
“A handful of members of Congress, allied with the nation’s major drug distributors, prevailed upon the DEA and the Justice Department to agree to a more industry-friendly law, undermining efforts to stanch the flow of pain pills …
The DEA had opposed the effort for years. The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.
The chief advocate of the law that hobbled the DEA was Rep. Tom Marino, a Pennsylvania Republican who is now [Trump’s] nominee to become the nation’s next drug czar.” [Marino withdrew his name for the post the day after this article was published.]
In April 2016, at the height of the deadliest drug epidemic in U.S. history, Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets.
By then, the opioid war had claimed 200,000 lives, more than three times the number of U.S. military deaths in the Vietnam War. Overdose deaths continue to rise. There is no end in sight.
A handful of members of Congress, allied with the nation’s major drug distributors, prevailed upon the DEA and the Justice Department to agree to a more industry-friendly law.
The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.
The chief advocate of the law that hobbled the DEA was Rep. Tom Marino,a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar. Marino spent years trying to move the law through Congress.
The chief advocate of the law that hobbled the DEA was Rep. Tom Marino,a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar. Marino spent years trying to move the law through Congress.
It passed after Sen. Orrin G. Hatch (R-Utah) negotiated a final version with the DEA.
The new law makes it virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies, according to internal agency and Justice Department documents and an independent assessment by the DEA’s chief administrative law judge in a soon-to-be-published law review article. That powerful tool had allowed the agency to immediately prevent drugs from reaching the street.
Political action committees representing the industry contributed at least $1.5 million to the 23 lawmakers who sponsored or co-sponsored four versions of the bill, including nearly $100,000 to Marino and $177,000 to Hatch. Overall, the drug industry spent $102 million lobbying Congress on the bill and other legislation between 2014 and 2016, according to lobbying reports.
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| Joseph T. Rannazzisi, seen here in September, ran the DEA’s division responsible for regulating the drug industry and led a decade-long campaign of aggressive enforcement until he was forced out of the agency in 2015. (Jahi Chikwendiu/The Washington Post) |
“The drug industry, the manufacturers, wholesalers, distributors and chain drugstores, have an influence over Congress that has never been seen before,” said Joseph T. Rannazzisi, who ran the DEA’s division responsible for regulating the drug industry and led a decade-long campaign of aggressive enforcement until he was forced out of the agency in 2015. “I mean, to get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows me how much influence they have.”
Besides the sponsors and co-sponsors of the bill, few lawmakers knew the true impact the law would have. It sailed through Congress and was passed by unanimous consent, a parliamentary procedure reserved for bills considered to be noncontroversial. The White House was equally unaware of the bill’s import when President Barack Obama signed it into law, according to interviews with former senior administration officials.
Top officials at the White House and the Justice Department have declined to discuss how the bill came to pass.
Michael Botticelli, who led the White House Office of National Drug Control Policy at the time, said neither Justice nor the DEA objected to the bill, removing a major obstacle to the president’s approval.
“We deferred to DEA, as is common practice,” he said.
The bill also was reviewed by the White House Office of Management and Budget.
“Neither the DEA nor the Justice Department informed OMB about the policy change in the bill,” a former senior OMB official with knowledge of the issue said recently. The official spoke on the condition of anonymity because of the sensitivity of internal White House deliberations.
The DEA’s top official at the time, acting administrator Chuck Rosenberg, declined repeated requests for interviews. A senior DEA official said the agency fought the bill for years in the face of growing pressure from key members of Congress and industry lobbyists. But the DEA lost the battle and eventually was forced to accept a deal it did not want.
“They would have passed this with us or without us,” said the official, who spoke on the condition of anonymity. “Our point was that this law was completely unnecessary.”
Loretta E. Lynch, who was attorney general at the time, declined a recent interview request.
Obama also declined to discuss the law. His spokeswoman, Katie Hill, referred reporters to Botticelli’s statement.
The DEA and Justice Department have denied or delayed more than a dozen requests filed by The Post and “60 Minutes” under the Freedom of Information Act for public records that might shed additional light on the matter. Some of those requests have been pending for nearly 18 months. The Post is now suing the Justice Department in federal court for some of those records.
Hatch’s spokesman, Matt Whitlock, said the DEA, which had undergone a leadership change, did not oppose the bill in the end.
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Industry officials defended the new law as an effort to ensure that legitimate pain patients receive their medication without disruption. The industry had long complained that federal prescription drug laws were too vague about the responsibility of companies to report suspicious orders of narcotics. The industry also complained that the DEA communicated poorly with companies — citing a 2015 report by the Government Accountability Office — and was too punitive when narcotics were diverted out of the legal drug distribution chain.
“To be clear — this law does not ‘decrease’ DEA’s enforcement against distributors,” said John Parker, a spokesman for the Healthcare Distribution Alliance, which represents drug distributors. “It supports real-time communication between all parties in order to counter the constantly evolving methods of drug diversion.”
But DEA Chief Administrative Law Judge John J. Mulrooney II has reached the opposite conclusion.
“At a time when, by all accounts, opioid abuse, addiction and deaths were increasing markedly” the new law “imposed a dramatic diminution of the agency’s authority,” Mulrooney wrote in a draft 115-page article provided by the Marquette Law Review editorial board. He wrote that it is now “all but logically impossible” for the DEA to suspend a drug company’s operations for failing to comply with federal law. The agency declined to make Mulrooney available for an interview.
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| D. Linden Barber helped design the DEA’s aggressive enforcement campaign. When he left to work for the drug industry in 2011, he brought knowledge of the DEA’s strategy and how it could be attacked to protect the companies. (U.S. Senate) |
Deeply involved in the effort to help the industry was the DEA’s former associate chief counsel, D. Linden Barber.While at the DEA, he helped design and carry out the early stages of the agency’s tough enforcement campaign, which targeted drug companies that were failing to report suspicious orders of narcotics.
When Barber went to work for the drug industry in 2011, he brought an intimate knowledge of the DEA’s strategy and how it could be attacked to protect the companies. He was one of dozens of DEA officials recruited by the drug industry during the past decade.
Barber played a key role in crafting an early version of the legislation that would eventually curtail the DEA’s power, according to an internal email written by a Justice Department official to a colleague. “He wrote the Marino bill,” the official wrote in 2014.
Barber declined repeated requests for an interview.
With a few words, the new law changed four decades of DEA practice. Previously, the DEA could freeze drug shipments that posed an “imminent danger” to the community, giving the agency broad authority. Now, the DEA must demonstrate that a company’s actions represent “a substantial likelihood of an immediate threat,” a much higher bar.
“There’s no way that we could meet that burden, the determination that those drugs are going to be an immediate threat, because immediate, by definition, means right now,” Rannazzisi said.
Today, Rannazzisi is a consultant for a team of lawyers suing the opioid industry. Separately, 41 state attorneys general have banded together to investigate the industry. Hundreds of counties, cities and towns also are suing.
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Joe Rannazzisi came to DEA headquarters as an outsider with an attitude. He worked as an agent in Detroit, where he watched prescription drugs flood small towns and cities in the Midwest.
Hundreds of millions of pain pills, such as Vicodin and oxycodone, ended up in the hands of dealers and illegal users.
Rogue doctors wrote fraudulent prescriptions for enormous numbers of pills, and complicit pharmacists filled them without question, often for cash. Internet pharmacies, supplied by drug distribution companies, allowed users to obtain drugs without seeing a doctor.
“There were just too many bad practitioners, too many bad pharmacies, and too many bad wholesalers and distributors,” Rannazzisi recalled.
Rannazzisi, a burly, tough-talking Long Islander, was assigned to head the DEA’s Office of Diversion Control. He had a law degree, a pharmacy degree and had spent years navigating the DEA’s bureaucracy.
The office was seen as a backwater operation whose 600 investigators had toiled for years over prescription drug cases with little or none of the recognition that went to those who investigated illegal street drugs like heroin or cocaine.
Rannazzisi brought an aggressive approach to the diversion control office.
The year he took over, Linden Barber was promoted to run diversion control’s litigation office, which crafted the legal arguments that supported the team. He was a former Army lawyer who served in Iraq. The cadre of attorneys who worked for him saw him as a tough litigator unafraid of an influential industry.
Barber and Rannazzisi formed a powerful combination that the drug companies would learn to fear. “Early on he did really good work,” Rannazzisi said. “He jumped into the Internet cases when he first came here.”
After shutting down the Internet pharmacies, Rannazzisi and Barber pursued the pain management clinics that replaced them and soon became as ubiquitous in South Florida as the golden arches of McDonald’s. To get there, drug dealers and users would take the “Oxy Express” down Interstate 75.
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| Matthew Murphy, formerly of the DEA, recalls a meeting with the president of a drug company who put his hands up and said, “ ‘You got us. What can we do to make this right?’ ” Murphy said he had heard the same thing from drug dealers, but “the heroin and cocaine traffickers didn’t have a class ring on their finger from a prestigious university.” (Katye Martens Brier/For The Washington Post) |
“Lines of customers coming in and going out,” said Matthew Murphy, a veteran DEA supervisor in Boston whom Rannazzisi hired to be chief of pharmaceutical investigations. “Armed guards. Vanloads of people from the Appalachia region driving down to Florida to get a prescription from a pain clinic and then get the prescription filled, going back to wherever they’re from.”
Back home, each 30-pill vial of oxycodone was worth $900.
DEA officials realized they needed a new strategy to confront this new kind of drug dealer.
“They weren’t slinging crack on the corner,” Rannazzisi said. “These were professionals who were doing it. They were just drug dealers in lab coats."
Rather than focusing on bad doctors and pharmacists, Rannazzisi and Barber decided to target the companies feeding the pill mills: the wholesale drug distributors, some of them massive multinational corporations.
“I developed the legal framework to pursue actions against distributors,” Barber would later say. “We initiated a record number of administrative actions; the government collected record-setting civil penalties.”
Under the Controlled Substances Act of 1970, drug companies are required to report unusually large or otherwise suspicious orders. Failure to do so can result in fines and the suspension or loss of DEA registrations to manufacture or distribute narcotics.
When the DEA suspected that a company was ignoring suspicious sales, the agency filed an “order to show cause.” That gave a company at least 30 days to explain why the agency should not revoke its registration.
In the most egregious cases, the DEA employed an “immediate suspension order,” allowing the agency to lock up a distributor’s drugs. The orders instantly halted all commerce in controlled substances on the grounds that the drugs constituted an “imminent danger” to the community.
Under Rannazzisi in the mid-2000s, the DEA repeatedly warned the companies that they were shipping unusually large volumes of opioids to customers around the country. Despite the warnings, some companies continued the shipments.
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| In 2007, the agency took action against McKesson, the nation’s largest drug distributor, for failure to report hundreds of suspicious orders. The company paid $13.2 million. (Justin Sullivan/Getty Images) |
The DEA soon began bringing enforcement actions against distributors. In 2007, the agency moved against McKesson, the nation’s largest drug distributor and the fifth-largest corporation in the nation, for failing to report hundreds of suspicious orders placed by Internet pharmacies. McKesson settled the case, paying a $13.2 million fine.
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| Cardinal Health Inc. paid a $34 million fine after the DEA brought a case in 2008 that claimed the company filled “blatantly suspicious” orders from online drugstores. (Gary Gardiner/Bloomberg News |
In 2008, Rannazzisi and Barber targeted Cardinal Health, another large drug distributor, for filling “blatantly suspicious” orders from online drugstores. Cardinal paid a $34 million fine.
The DEA would ultimately bring at least 17 cases against 13 drug distributors and one manufacturer. The government said it assessed nearly $425 million in fines over a decade. Those fines reflect only a small portion of the hundreds of billions of dollars in revenue the companies receive each year.
“It’s a cost of doing business,” Murphy said.
Along the way, Rannazzisi was making powerful enemies in the industry.
“They definitely didn’t like Joe Rannazzisi,” Murphy said. “Not at all. He wasn’t viewed as a person that they could work with. And maybe that was appropriate. He didn’t want to work with industry much.”
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| The departure of so many DEA employees for the drug industry gave the distributors an unfair advantage, said Jonathan P. Novak, formerly a DEA lawyer. “There was a fear,” he said. “It comes from seeing that some of the best and brightest former DEA attorneys are now on the other side and know all of the weak points.” (Bonnie Jo Mount/The Washington Post) |
Dozens of top officials from the DEA and Justice Department have stepped through Washington’s revolving door to work for drug companies.
Two former U.S. deputy attorneys general have defended Cardinal, one of the “Big Three” companies, along with McKesson and AmerisourceBergen, that together control 85 percent of drug distribution in the United States. Jamie Gorelick, an attorney for WilmerHale, was deputy attorney general under President Bill Clinton. Craig S. Morford, Cardinal’s chief legal and compliance officer, was acting deputy attorney general under President George W. Bush.
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The major drug companies brought their campaign to Capitol Hill. One of their key allies was Tom Marino, then a two-term Republican congressman from Williamsport, Pa.
Marino was a former county and federal prosecutor with deep hometown ties to a district that was reeling from the opioid epidemic.
On Feb. 18, 2014, Marino introduced the Ensuring Patient Access and Effective Drug Enforcement Act, making an effort to define what constitutes “imminent danger.” The proposal raised the DEA’s standard for suspending drug shipments by requiring that the agency establish “a significant and present risk of death or serious bodily harm that is more likely than not to occur.”
It attracted 14 Republican co-sponsors, chief among them Rep. Marsha Blackburn (R-Tenn.), also from a region in the grip of the epidemic....Ms. Blackburn received $120,000 in campaign contributions from the pharmaceutical industry. She did not respond to requests for an interview. She announced this month that she will run for the seat of Sen. Bob Corker (R-Tenn.), who is not seeking reelection.
Read more at Washington Post