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 epidemic 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.
A handful of members of Congress, allied with the nation's major drug distributors, pushed for 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 chief advocate of the law was Rep. Tom Marino, a Pennsylvania Republican who is now President Donald Trump's nominee to become the nation's next Director of the Office of National Drug Control Policy. Marino spent years trying to move the law through Congress. It passed after Sen. Orrin 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 shut down suspicious sales of hundreds of millions of pills.
The new law makes it nearly 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 $106 million lobbying Congress on the bill and other legislation between 2014 and 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 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. "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."
NO OBJECTIONS
The legislation was passed by unanimous consent in Congress, 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 the Justice Department 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 [the Office of Management and Budget] about the policy change in the bill," a former senior Office of Management and Budget official with knowledge of the issue said recently. The official spoke on the condition of anonymity.
The DEA's top official at the time, acting administrator Charles Rosenberg, declined 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 Lynch, who was attorney general at the time, declined a recent interview request.
Obama also declined to discuss the law. His spokesman, 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.
"We worked collaboratively with DEA and DOJ ... and they contributed significantly to the language of the bill," Whitlock wrote in an email. "DEA had plenty of opportunities to stop the bill and they did not do so."
Marino declined requests for comment. 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."
But DEA Chief Administrative Law Judge John 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.
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.
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 requests for an interview.
A HIGHER BAR
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.
"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.'"
Mulrooney has been documenting the falling number of immediate suspension orders against doctors, pharmacies and drug companies. That number dropped from 65 in fiscal 2011 to eight in fiscal 2016, according to the DEA. Not a single order has targeted a distributor or manufacturer since late 2015, according to Mulrooney's reports, which were obtained under the Freedom of Information Act.
The DEA said in a statement last week that it is still pursuing reckless doctors and rogue businesses with a wide variety of tools.
"We will continue fighting the opioid crisis and continue to use all the tools at our disposal to combat this epidemic," the statement said.
Marsha Blackburn, who co-sponsored the House version of the bill, 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 re-election.
In addition to Blackburn, Marino and Hatch, The Post sought comment from the other nine co-sponsors of the 2016 bill. Only four responded.
A spokesman for Sen. Sheldon Whitehouse, D-R.I., said the DEA could have expressed its opposition at any time.
"The fact that it passed the entire Senate without hearing any sort of communication that would have triggered concern of at least one senator doesn't really pass the smell test," the spokesman said.
Marino declined to be interviewed for this story, but last year he 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 to [do] anything but put another notch in his belt."
Since 2014, the year Marino first introduced his bill, 106 people have died of opioid overdoses in his district, Lycoming County, Pa. Over six days this summer, 53 people in the county overdosed on opioids. Three of them died.
Information for this article was contributed by Steven Rich, Alice Li, Alice Crites, Reis Thebault and Sarah Bowman of The Washington Post.
A Section on 10/16/2017