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, undermining efforts to stanch the flow of pain pills, according to an investigation by The Washington Post and “60 Minutes.” 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 and President Trump’s nominee to become the nation’s 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.
For years, some drug distributors were fined for repeatedly ignoring warnings from the DEA to stop suspicious sales of millions of pills, while they racked up billions of dollars in sales.
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 tool had allowed the agency to prevent drugs from reaching the street.
Political action committees representing the industry contributed at least $1.5 million to 23 lawmakers who sponsored or co-sponsored versions of the bill, including nearly $100,000 to Marino and $177,000 to Hatch. The industry spent $106 million lobbying Congress on legislation from 2014 to 2016, according to lobbying reports.
“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 enforcement until he was forced out of the agency in 2015. “To get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows 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 DEA objected to the bill, removing a major obstacle to presidential 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.
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 light on the matter. Some requests have been pending for nearly 18 months. The Post is now suing the Justice Department in federal court for some of those records.
Marino declined repeated requests for comment. Marino’s staff called U.S. Capitol Police when The Post and “60 Minutes” tried to interview the congressman at his office Sept. 12. In the past, the congressman has said the DEA was too aggressive and needed to work more collaboratively with drug companies.
Drug industry officials and experts blame the origins of the opioid crisis on the overprescribing of pain pills by doctors. The industry notes that the DEA approves the total amount of opioids produced each year.
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.”
DEA Chief Administrative Law Judge John J. Mulrooney II reached the opposite conclusion. “At a time when, by all accounts, opioid abuse, addiction and deaths were increasing” the new law “imposed a dramatic diminution of the agency’s authority,” Mulrooney wrote in a draft of an article provided by the Marquette Law Review editorial board. He wrote 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.
Deeply involved in the effort to help the industry was the DEA former associate chief counsel, D. Linden Barber. While at the DEA, he helped design the early stages of the agency’s enforcement campaign, which targeted drug companies failing to report suspicious narcotic orders. When Barber went to work for the drug industry in 2011, he brought a knowledge of 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 in 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, DEA must demonstrate a company’s actions represent “substantial likelihood of an immediate threat,” a 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 and towns also are suing.
“This is an industry that’s out of control. If they don’t follow the law in drug supply, and diversion occurs, people die. That’s just it, people die,” he said. “And what they’re saying is, ‘The heck with your compliance. We’ll just get the law changed.’ ”
Under the Controlled Substances Act of 1970, drug companies are required to report unusually large or 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.
Major drug companies also brought their campaign to Capitol Hill. One key ally was Tom Marino, then a two-term Republican congressman from Williamsport.
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.”
On July 29, the Marino bill passed the House and went to the Senate. The Justice Department was so concerned that it took the unusual step of having Attorney General Holder publicly oppose the bill.
The bill stalled in the Senate. On April 21, 2015, the House took up Marino’s bill.
On the floor of Congress, Marino said: “This bill will bring much-needed clarity to critical provisions of the Controlled Substances Act. In doing so, we will ensure that the DEA’s authorities are not abused and threatened by future legal challenges; foster greater collaboration, communication and transparency between the DEA and the supply chain; create more opportunities to identify bad actors at the end of the supply chain; and, most importantly, be certain that prescriptions are accessible to patients in need.”
The House passed the bill by unanimous consent. On March 17, 2016, the Senate passed the bill by unanimous consent. On April 12, the House approved the Senate version by unanimous consent. On April 19, Obama signed the bill.
Marino, now in his fourth term, continues to represent northeastern Pennsylvania and Lycoming County. His nomination as drug czar, which would put him in charge of the White House Office of National Drug Control Policy, is pending.
He declined to be interviewed, but last year told The Post: “We had a situation where it was just out of control because of (Rannazzisi),” Marino said. “His only mission was to get big fines. He didn’t want anything but another notch in his belt.”
Since 2014, the year Marino first introduced his bill, 106 people have died of opioid overdoses in Lycoming County.