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Justice Dept. to target opioid manufacturers, distributors in new push to curb deadly epidemic

In an effort to combat the opioid crisis, Attorney General Jeff Sessions announces a new task force targeting opioid distributors and manufacturers. (Video: The Washington Post)

Attorney General Jeff Sessions announced Tuesday that a new task force would target drug manufacturers and distributors for their roles in the opioid epidemic, raising the possibility of filing criminal charges against them.

The Justice Department also said it would file a statement of interest in hundreds of lawsuits against drug companies brought by cities, counties and medical institutions seeking reimbursement for the cost of the drug crisis. Sessions said the Justice Department would seek repayment as well, arguing that the federal government has borne substantial costs.

“We will use criminal penalties. We will use civil penalties. We will use whatever laws and tools we have to hold people accountable if they break our laws,” Sessions said at a news conference attended by several state attorneys general.

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Sessions’s announcement was part of a flurry of activity this week at the White House, on Capitol Hill and elsewhere that may mark the beginning of an intensified federal effort to address the deadly drug epidemic sweeping the country.

The White House is holding a drug crisis summit Thursday with Cabinet secretaries. Hearings on eight anti-drug bills in the House will begin Wednesday before the Energy and Commerce Committee. And the new secretary of health and human services, Alex Azar, has embraced the expansion of medically assisted drug treatment.

John M. Gray, president and chief executive of the Healthcare Distribution Alliance, which represents drug distributors, said in a statement Tuesday that “distributors share the common goal with Attorney General Sessions of ending this opioid epidemic. In support of that goal, we have put forth a number of practical solutions and policy proposals that would meaningfully reduce misuse and abuse of prescription opioids.

“At the same time,” he added, “we know that we cannot do this alone.”

Arkansas Attorney General Leslie Rutledge (R) discussed initiatives to combat the growing opioid crisis. (Video: The Washington Post)

The association that represents pharmaceutical manufacturers declined to comment.

States and cities have absorbed most of the cost and carnage of the drug crisis, which killed nearly 64,000 people in 2016 and is straining local emergency and health services. About two-thirds of the overdose deaths were caused by opioids, led by illicit fentanyl.

The failure of drug manufacturers and distributors to report diversion of narcotic painkillers from pharmacies to the black market, coupled with widespread over-prescription by doctors, allowed hundreds of millions of pills such as oxycodone and hydrocodone to spill onto the street in recent years. Those legal drugs, intended to treat moderate to severe pain, are widely blamed for starting the epidemic.

The House Energy and Commerce Committee, which is investigating pill dumping in West Virginia, reported this month, for example, that McKesson and Cardinal Health — two of the three largest opioid distributors — shipped 12.3 million pills to a single pharmacy in a tiny West Virginia town from 2006 to 2014.

The Drug Enforcement Administration has battled those companies with administrative and civil court actions that resulted in fines, but it has never brought a criminal charge against a company for failing to report suspicious orders of legal drugs. In 2007, Purdue Pharma and three of its executives pleaded guilty to criminal charges of misleading doctors and the public about the addiction risk of OxyContin and paid more than $600 million in fines.

Many of the hundreds of lawsuits against drug companies have been consolidated before U.S. District Judge Dan Polster in Ohio for settlement talks. Purdue said in a statement Tuesday that “we are fully engaged in the process that Judge Polster has set in action to explore meaningful solutions to the crisis of prescription and illicit opioid abuse addressed in the Attorney General’s statement.”

President Trump declared the opioid epidemic a “health emergency” in October, but cities overwhelmed by the crisis have complained that there has been little action or money from Washington in the months since.

White House senior adviser Kellyanne Conway, who is leading the administration’s drug efforts, noted that funding for opioid programs was boosted by $6 billion in a budget deal passed this month and that rule changes made by HHS will make it easier for people to access treatment. But many experts, including the president’s commission on the opioid crisis, have called for a much wider range of responses and vastly more money to combat the crisis.

The administration also plans to roll out a messaging campaign on opioids that will include advertisements, marketing and educational components, Conway said. She said it is intended to “break through the stigma and silence” surrounding addiction.

“People should feel free to come forward and say, ‘I think my colleague has a problem’ or ‘I’m worried about my mother,’ ” she said.

That includes a White House project encouraging Americans to tell their personal stories about what the administration is calling “the crisis next door.” Conway wants people who have used drugs, the loved ones of opioid addicts, first responders and anyone else touched by the crisis to share their stories with the White House.

Conway said Trump started the project in October, when he spoke about his brother’s battle with alcoholism.

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Conway said she expects Thursday’s event to function as a “progress report” for Cabinet secretaries, who will explain how they are working to combat opioid addiction.

The administration also is looking at strengthening penalties for fentanyl dealing and criminal trafficking. Conway said the administration is considering whether to make trafficking large quantities of fentanyl a capital crime because of its potential to kill so many.

Sessions said the newly created “Prescription Interdiction & Litigation Task Force” will use civil and criminal enforcement methods to ensure distributors and pharmacies are obeying laws on diversion and improper dispensing of drugs. The task force also plans to use the False Claims Act and other tools to crack down on pain management clinics, drug-testing facilities and physicians who write bogus opioid prescriptions.

“We will seek to hold accountable those whose illegality has cost us billions of taxpayer dollars,” Sessions said.

Other parts of the administration are turning their focus toward treatment. In comments to the nation’s governors over the weekend, Azar stressed the need to expand the number and types of medications available for treatment of opioid addiction — and the number of people who have access to them.

Azar noted that medication-assisted treatment is available only in about a third of treatment programs. Unless many more people receive such medications, he said, “it will be nigh impossible to turn the tide on this epidemic.”

There are three drugs approved by the Food and Drug Administration for opioid addiction: buprenorphine, methadone and naltrexone. To increase the number and type of treatments, the FDA has prepared two draft guidelines that may be issued as soon as next month. One, Azar said, will “correct a misconception” that patients must completely abstain from drugs for treatment to be effective, and the other will spell out how manufacturers can more easily win approval for extended-release buprenorphine.

In May, former HHS secretary Tom Price outraged addiction experts when he said that using medication-assisted treatments was “substituting one opioid for another.”

Joshua Sharfstein, an associate dean at the Johns Hopkins Bloomberg School of Public Health, said the embrace of medication-assisted treatment is in conflict with the administration’s moves to undermine the Affordable Care Act and Medicaid, which provide insurance to millions of Americans and help people gain access to that treatment.

“I think that it really is about prioritizing the opioid epidemic over whatever ideology is underlying the rollbacks on insurance coverage,” said Sharfstein, who was the deputy commissioner of the FDA in the Obama administration.

Amy Goldstein, Laurie McGinley and Josh Dawsey contributed to this report.

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