INV-OXY

For years, Joe Rannazzisi led the government’s war against opioid abuse at the DEA. He says he was pushed out by members of Congress amid a drug industry campaign to weaken enforcement.

Newly unsealed documents in a landmark civil case in Cleveland provide clues to one of the most enduring mysteries of the opioid epidemic: How were drug companies able to weaken the federal government’s most powerful enforcement weapon at the height of the crisis?

The industry enlisted members of Congress to limit the powers of the Drug Enforcement Administration. It devised “tactics” to push back against the agency. And it commissioned a “Crisis Playbook” to burnish its image and blame the federal government for not doing enough to stop the epidemic.

The new information is emerging through the efforts of lawyers in the massive federal lawsuit against two dozen drug companies in Cleveland who have obtained depositions from high-ranking company officials, internal company emails and confidential memos. The documents were unsealed in July after a year-long legal fight by The Washington Post and the owner of the Charleston Gazette-Mail in West Virginia.

In 2016, the drug companies convinced members of Congress and Obama administration officials to rein in the DEA and force the agency to treat them as “partners” in efforts to solve the crisis. The crowning achievement of the companies was a piece of legislation known as the “Marino bill,” named after its original sponsor, which curbed the DEA’s ability to immediately suspend the operations of drug companies that failed to follow the law.

OPIOIDS

Attorney General Loretta Lynch’s Justice Department did not stand in the way of the Marino bill.

The full story has never been told because so few of the people involved will talk about it. The list of people who have declined to be interviewed includes former congressman Tom Marino, R-Pa., who first proposed the bill; former acting DEA administrator Chuck Rosenberg, whose agency surrendered to the pressure; former Attorney General Loretta Lynch, whose department did not stand in the way of the legislation; and, finally, then-President Barack Obama, who signed it into law.

The lawsuit, filed on behalf of more than 2,000 cities, towns and counties in federal court in Cleveland, seeks to hold the industry accountable for the opioid epidemic. The plaintiffs’ lawyers are pursuing their civil case under the Racketeer Influenced and Corrupt Organizations (RICO) Act, a law crafted to attack criminal organizations.

“Defendants carried out their coordinated strategy to weaken the DEA’s enforcement capabilities in part through the Marino Bill,” states a filing by the plaintiffs’ lawyers in the case.

Lawyers for the drug companies have ridiculed the RICO argument and asked U.S. District Judge Dan Polster to toss out the case before it heads to trial, which is scheduled to begin Oct. 21.

“Plaintiffs have no evidence that Distributors associated with Manufacturers or one another, as part of a continuing unit, for the ‘common purpose of engaging in a course of unlawful conduct,’ ” drug company lawyers wrote in their motion to dismiss, which was denied by Judge Dan Polster on Sept. 10.

In a statement, the Healthcare Distribution Alliance, the association that represents drug distributors, defended its support of the Marino bill, formally known as the Ensuring Patient Access and Effective Drug Enforcement Act.

“The intent of the law was not to decrease the DEA’s enforcement against distributors,” the alliance said in a statement. “HDA believed that the legislation would help provide greater clarity to one element of DEA’s enforcement standards and encourage communication and coordination that was much-needed between the DEA and the industry.”

The alliance also noted that the bill was approved by both houses of Congress and signed by Obama.

Beginning in 2006, the DEA went after drug distributors and pharmacies for failing to report suspicious orders of millions of opioid pills that spilled into the black market. Over the next decade, the DEA brought two dozen enforcement cases and forced the companies to pay $500 million in fines.

Executives of the nation’s largest drug manufacturers and distributors were alarmed.

“The DEA is now hammering all of us,” Ann Berkey, then a senior vice president of McKesson Corp., wrote in a 2014 email to another senior McKesson officer, according to a deposition in the Cleveland case.

During meetings at resorts in places like Pebble Beach, Calif., and Palm Beach, Fla., the industry alliance charted a way to respond. They implemented a political strategy that they knew the DEA believed would result in “tying the agencies [sic] hands to actively and aggressively address diversion and compliance,” according to an internal alliance memo that is now part of the case.

The strategy worked.

Cracking down

By 2005, the opioid crisis was claiming 10,000 lives a year.

The DEA mounted a crusade against internet pharmacies and corrupt doctors and then took on the companies making and distributing the opioids to prevent drugs from being diverted to the black market.

The effort was led by Joe Rannazzisi, a hard-charging DEA agent from New York who worked the streets of Detroit before being promoted to lead the DEA’s Office of Diversion Control, a small unit that was seen at the time as something of a backwater in an agency devoted to pursuing high-profile heroin, cocaine and marijuana cases.

Working on the honor system

The DEA had always relied on drug manufacturers, distributors and pharmacies to police themselves by monitoring suspicious orders and reporting them to the agency. It was essentially an honor system. The flow of pharmaceuticals was simply too immense for the DEA to monitor on its own.

Rannazzisi and his DEA legal counsel, D. Linden Barber, wrote to drug distributors and manufacturers, warning them to more closely track their painkillers and stop suspiciously large shipments to pharmacies.

The warnings didn’t work. The DEA decided to get tougher. It had several tools at its disposal, in ascending order of severity: It could send a company a “letter of admonition” warning it to follow the law; it could send an “order to show cause” demanding to know why operations should not be shut down for failing to report suspicious orders; it could issue “an immediate suspension order” instantly halting operations; or it could bring a civil or criminal enforcement case with heavy fines.

But cases against big companies were difficult to make, requiring on-the-ground investigations involving numerous interviews and thousands of pages of documents. They could take years to complete.

In 2013, Marino, a U.S. attorney from Pennsylvania, was a second-term Republican congressman from Williamsport, a community that had been ravaged by the opioid epidemic. Representatives from the industry enlisted Marino and then-Rep. Marsha Blackburn, R-Tenn., whose state also was hard hit by opioids, to their cause.

Both lawmakers told industry lobbyists that they would be willing to work with the drug companies and had expressed interest in introducing legislation on their behalf, according to an email unsealed in the Cleveland case.

“Rep. Marino’s office is very open to feedback and additional ideas,” Jewelyn Cosgrove, a lobbyist for the alliance, wrote to her colleagues on June 12, 2013.

Six months later, drug company representatives gathered at the alliance’s headquarters in northern Virginia for a “DEA Strategy Task Force Meeting.” The companies included McKesson, Cardinal and AmerisourceBergen, along with several other distributors, including H.D. Smith.

The representatives identified “three areas of attack,” according to an email written by H.D. Smith Senior Vice President Tom Twitty on Dec. 12, 2013, and recently unsealed in the case.

Twitty told his bosses that the industry representatives had agreed to work together and discussed ways to “prepare for blowback” on the “Marino/Blackburn bill,” which was about to be introduced on Capitol Hill. They also decided to use material from APCO Worldwide, the company that created the “Crisis Playbook,” to conduct a “targeted media outreach” campaign. They agreed it was time to craft industry responses to push back against negative news stories.

“My sense was that all were pretty passionate about going after this, except Cardinal,” Twitty wrote in the email. “More to come.”

Twitty declined to comment about the meeting. So did Cardinal. H.D. Smith has since been acquired by AmerisourceBergen.

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An email from Jack Crowley of Purdue Pharma to a counterpart at Cardinal Health.

Two months later, on Feb. 18, 2014, Marino and Blackburn introduced legislation on Capitol Hill that would redefine the law regulating suspicious orders filled by drug companies.The initial version of the legislation was written by Barber, according to an internal Justice Department document. Barber, the onetime DEA legal counsel who had worked alongside Rannazzisi, was representing some of the biggest names in the drug business, including Cardinal. He gave the industry intimate knowledge of the DEA’s strategy.

Barber, now a senior vice president at Cardinal, did not respond to requests for comment.

“The professional credentials and personal character of the Cardinal executives named in the reporting are unassailable and the company stands behind both their service to our country, and to Cardinal Health’s commitment to work hard every day to be part of the solution,” a Cardinal spokeswoman said in a statement to The Post.

The unsealed court records show Marino reached out to Cardinal, which was in the process of pushing for the legislation.

“One of our member companies had been contacted by Mr. Marino,” said Kelly, the top lobbyist for the alliance, which by then had changed its name to the Healthcare Distribution Alliance (HDA).

“Do you know which member company it was?” Kelly was asked during his deposition.

“It was Cardinal.”

“Then they reached out to you and asked HDA to participate?”

“They did.”

“Did HDA end up providing any drafting on the bill?”

“We did participate in that process,” Kelly said.The bill would create a high standard for the DEA to meet in order to immediately suspend a drug company’s operations, former DEA officials said. Previously, the DEA had to show only that a company’s actions were posing an “imminent danger to public health or safety.” The new bill defined “imminent danger” to mean that a company was creating “a significant and present risk of death or serious bodily harm.”

Former DEA agents and agency lawyers have told The Post it would be virtually impossible to show that a drug company thousands of miles from a particular community was posing a “present” risk.

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An email from a Purdue Pharma executive to colleagues that described the company’s role in the bill’s development.

Marino bill

In the spring of 2014, the alliance finalized preparations for an upcoming congressional hearing on the Marino bill. Scheduled to testify: Rannazzisi, Barber and John Gray, the president of the alliance.

On April 3, a Washington lobbying firm provided the alliance with questions for members of Congress to ask during the hearing, a common practice on Capitol Hill but not widely known outside Washington.

Kristen Freitas, the associate director of federal government affairs for the alliance, was concerned that the questions could be traced back to the outside lobbying firm, co-founded by Carlyle P. Thorsen, according to emails unsealed in the Cleveland case.

“This is all so sensitive and anxiety levels are high so we need to have some control over how these questions are shared,” Freitas wrote to Thorsen that day.

Thorsen, who runs Thorsen French Advocacy, also preferred to remain behind the scenes.

“Pls scrub my name and source info before they are forwarded,” he replied.

The alliance would go on to pay his firm $140,000 in lobbying fees that year, records show.

Thorsen declined to comment.

The suggested questions for lawmakers to ask included:

“What efforts is DEA engaged in to promulgate clear standards for prescribers, pharmacies, and distributors?”

“What are you doing [to] help well-intentioned registrants determine who they can do business with?”

On April 7, a House Energy and Commerce subcommittee held its hearing.

Among the questions that Blackburn asked Rannazzisi:

“Articulate what the efforts are that the DEA is engaged in to promulgate some clear standards for the prescribers, for the pharmacies, for the distributors?”

“What are you doing to help well-intentioned registrants to determine who they can do business with?”

Third time’s a charm

An internal email written in 2014 by Berkey, the then-McKesson senior vice president for public affairs, shows how the company’s lobbyists were also working with Rep. Michael C. Burgess, R-Texas, then vice chairman of a House Energy and Commerce subcommittee.

“Per our discussion with Rep. Burgess on Saturday, his office called me this afternoon before the hearing and asked me for questions he could ask DEA,” Berkey wrote in the email disclosed in an unsealed deposition.

Berkey and Burgess declined to comment.

The DEA and the Justice Department opposed the measure.

Gray, the president of the alliance, wrote a memo saying he had conversations with numerous members of his group, along with “select Hill staff.” Members of the alliance noted that the DEA believed the bill would be “tying the agencies (sic) hands,” according to the memo disclosed in an unsealed deposition.

Within a few months, the first bill died in a House committee.

Soon after, Marino and Blackburn introduced a second version, along with 11 co-sponsors.

This version also would have made proving cases more difficult for the DEA, according to former federal officials. It defined “imminent danger” as a case in which a company “intentionally distributed or dispensed” drugs “in a manner that poses a present or foreseeable risk of serious adverse health consequences or death.”

The bill also would require that drug companies be given an opportunity to file “corrective action” plans, which would delay any enforcement actions by the DEA.

In July 2014, after the House passed the bill, then-Attorney General Eric H. Holder Jr. publicly came out against it.

He said it “would severely undermine a critical component of our efforts to prevent communities and families from falling prey to dangerous drugs.” Michele Leonhart, then the DEA administrator, vehemently opposed the bill, according to Rannazzisi and other DEA officials.

The bill died in the Senate.

In September 2014, Marino and Blackburn accused Rannazzisi of trying to “intimidate the United States Congress” during a July 2 conference call with congressional staffers. They said Rannazzisi told them “you’ll be protecting criminals” with the bill.

The two lawmakers asked the Justice Department’s inspector general to investigate Rannazzisi, who denied their accusation. The investigation came to nothing, but Rannazzisi said it derailed his career.

In January 2015, Marino and Blackburn introduced a third version of the bill in the House. The next month, Sen. Orrin G. Hatch, R-Utah, the powerful chairman of the Finance Committee, introduced it in the Senate. The bill was called S.483.

On Sept. 28, 2015, Gray issued a directive to the members of the alliance during a board of directors meeting, according to the unsealed court records. “Item Number 1” on the agenda: “Exhaust all efforts to secure passage of S.483.”

Signed into law

This bill also created a high bar for action, according to a former senior Justice official who spoke on the condition of anonymity to discuss internal deliberations. The measure defined “imminent danger” as “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur.”

DEA officials still did not want the bill but felt there was “too much momentum” for it in Congress, the Justice official said. DEA officials said the bill, which removed the word “intentionally” and replaced “present” with “immediate,” was a less bad option, the Justice official said.

For those reasons, the DEA did not raise a red flag with Justice, the official said. The Post has previously reported that a White House official, speaking anonymously, said that neither the DEA nor the Justice Department raised objections to the bill.

On March 17, the Senate passed the measure by unanimous consent. The House followed weeks later. Not one lawmaker opposed it.

“The bill is one we have been working on with HDMA and [the National Association of Chain Drug Stores] for the past two years,” Burt Rosen, Purdue Pharma’s vice president for government affairs, wrote that evening in an email to his colleagues that was unsealed in the Cleveland case. “Purdue was very active in influencing the ultimate definition of an ‘imminent danger to the public health or safety.’ ”

Rosen declined an interview request. Josephine Martin, a spokeswoman for Purdue Pharma, declined to discuss Rosen’s email and said no one from the company would comment because of the pending litigation in Cleveland.

The change in position at Justice and DEA came after a change in leadership at the two agencies.

Holder’s successor, Loretta E. Lynch, has never publicly explained why the Justice Department switched its position.

Leonhart’s successor, Chuck Rosenberg, has never explained why he did not oppose the bill.

Obama signed the bill into law on April 19, 2016. He has never spoken publicly about it.

Lynch, Rosenberg and Obama all declined repeated interview requests from The Post. Marino did not return requests for an interview.Blackburn, now a U.S. senator, declined an interview request but provided a statement to The Postsaying she has worked to fight the opioid crisis.

“The Ensuring Patient Access and Effective Law Enforcement Act was passed unanimously by every Democrat and Republican in the United States House and Senate and signed into law by President Obama,” she said. “As a mom and a grandmom, my heart breaks for those touched by the opioid crisis.”

Since the first Marino bill was introduced, the sponsors and co-sponsors have received $1.4 million in campaign contributions from the industry and the alliance, according to campaign finance records.

Two months after Obama signed the bill, Rosenberg testified on Capitol Hill.

Hatch praised the DEA’s new chief.

“I’ve been told the DEA’s relationship with supply chain stakeholders has improved since you’ve taken the helm at DEA,” Hatch said. “I want to just say I applaud your efforts on this front.”

Hatch asked Rosenberg how he saw the “partnership” between the DEA and the industry “evolving.”

“The overwhelming majority, 99 plus percent, are our allies in this thing,” Rosenberg testified. “What we need is them as partners.”

More than a year later, in October 2017, The Post and “60 Minutes” published and broadcast a joint investigation into the circumstances surrounding the passage of the Marino bill. Several DEA officials who spoke on the condition of anonymity said they had fought the bill for years but eventually yielded to industry pressure that had created a wave of support for it in Congress.

In addition, the news organizations cited a law review article by the DEA’s chief administrative law judge, John J. Mulrooney II, who wrote that the Marino bill “imposed a dramatic diminution of the agency’s authority.”

The reporting had an immediate impact. Marino, who had been nominated by President Donald Trump to become the nation’s drug czar, withdrew from consideration two days after stories appeared.

“They made it and camouflaged it so well all of us were fooled,” Sen. Joe Manchin III, D-W.Va., said. “All of us. Nobody knew. That bill has to be retracted, has to be repealed.”

A spokesperson for Blackburn, one of the authors of the bill, said at the time “if there are any unintended consequences from this bipartisan legislation . . . they should be addressed immediately.”

Then-Attorney General Jeff Sessions said he was “dubious” about the law when he was a senator and had concluded that it should be changed. Forty-four state attorneys general, as well as congressional Democrats, also called for repeal. Maryland Attorney General Brian E. Frosh said the new law “handcuffs” the DEA.

Hatch publicly attacked the reporting by The Post and “60 Minutes” in 2017.

“This wasn’t some effort to help drug companies kill people,” he said. “This was an effort to ensure that DEA’s efforts . . . didn’t end up hurting legitimate patients.”

The industry alliance told The Post recently that the law did not weaken the DEA’s ability to issue immediate suspension orders against drug companies and cited 2017 testimony from Demetra Ashley, then acting chief of the agency’s Diversion Control division.

Ashley testified that the law did not “hamstring” the DEA. But she also said she was concerned about the agency’s ability to use immediate suspension orders against drug distributors and manufacturers.

“DEA along with the Department of Justice supports a change in the legislation,” she testified.

Since the bill became law, the DEA has issued no immediate suspension orders against manufacturers and one against a distributor in May 2018. The Louisiana distributor, Morris & Dickson, denied the allegations, saying the DEA failed to show any evidence of an immediate threat of death, serious bodily harm or abuse — the new standard in the Marino bill that became law. Two weeks later, the Justice Department rescinded the order.

In February and March 2018, U.S. Assistant Attorney General Stephen E. Boyd wrote letters to Congress requesting that the legislation be rewritten.

“After four months of repeated requests, DOJ finally offered specific feedback to this committee’s questions, stating they believe the law does impede the DEA’s ability to do its job,” said Rep. Greg Walden, R-Ore., then chairman of the House Energy and Commerce Committee.

Walden said in a statement Thursday that he is still waiting for guidance on how to rewrite the law from the DEA.

The Justice Department, which oversees the DEA, declined to comment. The DEA also declined to comment.

Drug distributors defended their role in the law in recent statements to The Post.

“Our nation’s drug supply chain is highly complex, so we routinely engage with elected officials and regulators to share our knowledge, experience and occasionally, recommendations,” McKesson said. “There is nothing inappropriate about companies communicating with policymakers in a transparent, law-abiding way to foster a more effective working relationship with the government.”

A Cardinal spokeswoman said the company supported the legislation, “which was passed unanimously in both chambers of Congress and signed into law by Obama, because it brought greater clarity to the regulatory landscape.”

AmerisourceBergen said the new law sought to clarify the industry’s responsibilities for opioids.

“We worked in conjunction with DEA and other members of industry to support its passage while keeping the DEA fully empowered,” a company spokesman said. “To the extent it can be proven there were any unintended consequences of the legislation, including lessened enforcement authority by DEA, we support parts of the law being reevaluated.”

The Marino bill remains the law today.

The Washington Post’s Alice Crites contributed to this report.

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Monday, October 21, 2019