The new law supported by opioid makers that Jeff Sessions, 44 states and a top DEA official want changed

Washington Post

A new law supported by opioid distributors and manufacturers is making it increasingly difficult to hold companies accountable when they run afoul of the nation's drug laws, according to recently retired Drug Enforcement Administration investigators on the front lines of the war against opioids.

They join a chorus of voices calling for changes to the law that includes Attorney General Jeff Sessions, 44 state attorneys general and the head of the DEA office that regulates pharmaceuticals.

The field investigators said the new law is hurting efforts to halt suspicious shipments of prescription pain pills and slowing the agency's investigative efforts. Morale within the ranks of the DEA's field divisions has plummeted, they said in interviews with The Washington Post and "60 Minutes" for a joint investigation that will be published and broadcast Sunday.

"The law makes it much harder for us to do our jobs," said James Rafalski, a DEA investigator who retired in June after a 39-year career in law enforcement, the last 13 years with the agency.

The Ensuring Patient Access and Effective Drug Enforcement Act of 2016 was pushed through Congress by a small band of lawmakers backed by a powerful array of drug companies. The law has undermined the DEA's most potent tools in the war against the opioid epidemic, according to agency investigators, agents, lawyers and the DEA's chief administrative law judge.

The legislation was the subject of a joint investigation by The Post and "60 Minutes" in October. On Sunday, a follow-up investigation will examine the obstacles investigators encountered during the biggest case the DEA has ever pursued against a drug distributor.

The law was sponsored by Rep. Tom Marino, R-Pa., in the House. Sen. Orrin G. Hatch, R-Utah, negotiated a final version with the DEA in the Senate.

After the October report, Marino withdrew his nomination to become drug czar, which would have put him in charge of the White House Office of National Drug Control Policy. Attorney General Sessions said that he was "dubious" about the law when he was a senator and has since come the conclusion that it should be changed. Forty-four state attorneys general, as well as Democratic lawmakers in Congress, have called for its repeal.

During a Senate Judiciary Committee hearing Tuesday, the head of the DEA office that regulates the pharmaceutical industry said the law has made enforcement more difficult in urgent circumstances and should be revised.

"The DEA, along with the Department of Justice, believes that has to change," said Demetra Ashley, acting assistant administrator in charge of the agency's Diversion Control Division.

John Parker, a spokesman for the Healthcare Distribution Alliance, the leading industry group for drug distributors, said the law has not hampered DEA's enforcement actions, which he pointed out had fallen before the law was enacted. Parker said the DEA has other tools to combat the epidemic, including controlling quotas for opioid production, punishing pharmacists and doctors, and tracking drug distribution data.

"The DEA is the only entity that has the full picture and scope of controlled substances across the supply chain," Parker said.

The Post has previously reported that DEA enforcement actions began dropping in 2013 after agency attorneys began requiring higher standards of proof to bring cases, as the DEA pursued a path of greater cooperation with industry.

DEA investigators and agents said in recent interviews with The Post and "60 Minutes" that the law has further hobbled their efforts at the height of the prescription opioid epidemic, which claimed nearly 200,000 lives between 2000 and 2016.

Previously, the agency had broad authority to freeze drug shipments that posed an "imminent danger" to the community in an action called an immediate suspension. Under the new law, the DEA must demonstrate that a company's actions represent "a substantial likelihood of an immediate threat," a much higher bar. The law also allows companies to submit "corrective action plans" before the DEA can sanction them.

"This Marino-Hatch bill is outrageous," said Jim Geldhof, a DEA program manager who retired in 2015 after 43 years with the DEA. "It basically takes any kind of action DEA was going to do with a distributor or manufacturer as far as an immediate suspension off the table. And then the other part of that really infuriates me is that corrective action plan."

Geldhof now works as a consultant to lawyers suing drug companies over the opioid crisis.

Supporters of the new law defend it as a means of protecting patients while not damaging the DEA.

"This was an effort to ensure that DEA's praiseworthy efforts to stem abuse don't end up hurting legitimate patients," Hatch said during Tuesday's Senate hearing. He noted that the law was an effort "to provide clearer guidance to supply chain members and to encourage greater cooperation between DEA and the registrant community."

Marino defended the law in a statement issued Tuesday.

"Throughout the entire process my office and Senator Hatch's office worked closely with the Department of Justice and the Drug Enforcement [Administration] to find acceptable language," he wrote. "When the legislation was finalized in the Senate, both the DOJ and the DEA had signed off on the final language. After the legislation was passed, there was no objection by the White House or any Agency and the bill was signed into law."

DEA investigators and agents said Hatch is misinformed.

"I could not disagree more," said David Schiller, who recently retired as the DEA's assistant special agent in charge of the Denver division after a 30-year career. "If somebody makes that statement, they don't have all the facts."

Helen Kaupang, who was a DEA investigator and supervisor for 29 years before she retired in September, said the law has made it more difficult to bring cases against companies suspected of violating the nation's drugs laws. She called the provision that permits companies to submit corrective plans a "get out of jail free card" because those plans delay the DEA from taking action against companies and allow them to continue to dispense drugs.

"I had young investigators that were enthusiastic. They were excited. They wanted to turn the world upside down," Kaupang said.

Since the passage of the law, she said, morale has plummeted.

"It's a very sad state of affairs," she said.

The October investigative report revealed that an early version of the law was written by a drug company lawyer who once worked at the DEA, according to a government email. The law was part of a multifaceted industry campaign to blunt enforcement efforts against drug companies.

Congress approved the bill by unanimous consent, a parliamentary procedure that does not require a recorded vote. President Barack Obama signed it into law in April 2016. Former administration officials said afterward that the White House was unaware of the bill's import. A senior DEA official said the bill was "completely unnecessary" and "would have passed with us or without us."

Rafalski, the recently retired DEA investigator, said he was particularly incensed by the provision of the law that allows a company suspected of wrongdoing to submit a corrective action plan before it can be sanctioned. He is now working as a consultant to lawyers suing drug companies.

In August 2016, after the law took effect, Rafalski was examining the documents of a drug company that was failing to properly monitor the controlled substances it handled.

On the third day of a scheduled three-week audit, the company notified Rafalski that it had filed a corrective action plan.

Rafalski said a less-experienced or aggressive investigator might have backed off at that point. But he said he persisted and demanded to see the company's records anyway. As he continued to conduct his audit, he said company officials realized that they would not be able to defend the number of violations he had found. The company voluntarily surrendered its DEA registration to handle controlled substances, he said.

"The attitude by investigators at the field level is there is no basis for this law," he said.

Democratic members of Congress, led by Sen. Claire McCaskill, D-Mo., have called for repealing the legislation. So far, no Republican senators have signed on.

Sen. Joe Manchin III, D-W. Va., who is co-sponsoring the repeal bill, said members of Congress were fooled by the legislation. He said it was "camouflaged" by carefully crafted legal language and carried a misleading title that promised access to drugs for patients who truly need them and tougher drug enforcement efforts against those who violate the law.

Manchin, whose state suffers from the highest prescription drug overdose rate in the nation, said he and his colleagues relied on the word of a handful of lawmakers that the legislation was noncontroversial and should be quickly passed by unanimous consent.

"When you get duped as we did, then it's our responsibility to fix it immediately," Manchin said. "We're going to overturn that bill. It has to be overturned. The power has to be back to the DEA. The DEA has to be held responsible for the job they're supposed to do, and we've got to make sure that's done and done immediately. There shouldn't be any hesitation."

Two days after The Post/"60 Minutes" report, Sen. Maggie Hassan, D-N.H., confronted Elizabeth Gallenagh, general counsel and senior vice president for government affairs at the Healthcare Distribution Alliance. The alliance has said the law does not undermine the DEA's enforcement powers.

Hassan questioned Gallenagh about a law review article written by Chief DEA Administrative Law Judge John J. Mulrooney II that was sharply critical of the Marino-Hatch bill.

"The point is that your organization - which lobbied aggressively for this law last year - claimed that it does not decrease the DEA's enforcement against distributors," she told Gallenagh during an Oct. 17 congressional hearing. "The DEA chief administrative law judge says you're wrong - that the law completely eliminates the DEA's ability to take certain enforcement actions. It's his job to interpret the law. So is the judge wrong? Or was your organization's statement misleading?"

"I believe that the judge's statement was misleading," Gallenagh said. "And I stand behind our organization's statement."

Hassan said in a recent interview that she was stunned to hear one of the nation's most influential drug industry groups attack the integrity of the DEA's chief judge.

"She accused the administrative law judge of misleading the public, of misleading us. And I thought that was astounding," Hassan said. "What I am looking for from the pharmaceutical industry is a true recognition that their product has fueled an addiction that is killing people and that they have an actual responsibility to do something about it. And I'm not seeing it."

Responding on behalf of Gallenagh, Parker pointed to a recent comment by Ashley, the DEA diversion chief, that agency employees have not been "hamstrung in a manner that we cannot continue to do our jobs."

Parker added that the alliance "would welcome the opportunity to meet with Sen. Hassan to discuss the law and its effect on enforcement in greater detail."

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