U.S. lawmakers and prosecutors unveiled new actions aimed at holding drug manufacturers and distributors accountable for their role in fueling the opioid epidemic — a crisis responsible for killing more than 100 Americans each day.
U.S. Attorney General Jeff Sessions said the federal Justice Department would bring all of its efforts intended to curb the opioid crisis under one banner through the creation of a new task force, dubbed PIL — Prescription Interdiction and Litigation.
Sessions said the PIL task force, which consists of senior Justice Department officials, is charged with aggressively deploying and coordinating all of the agency's available criminal and civil law enforcement capabilities to stem the tide of opioid overdoses in the U.S., with a particular focus on holding drug manufacturers and distributors responsible for any unlawful practices.
The task force is responsible for ensuring that opioid makers are following Food and Drug Administration rules and regulations in marketing their products. Those caught violating the rules will be punished, Sessions said.
"We will use criminal penalties. We will use civil penalties. We will use whatever tools we have to hold people accountable for breaking our laws," the attorney general told reporters during a Feb. 27 briefing.
Sessions said the task force would work closely with Health and Human Services, or HHS, and law enforcement and also examine existing state and local government lawsuits against opioid manufacturers to determine if the Justice Department could help.
He revealed that the department plans to file a so-called statement of interest in a lawsuit against a number of opioid manufacturers and distributors accused of using false, deceptive and unfair marketing practices.
The plaintiffs, which include a number of cities, municipalities and medical institutions, are seeking to recover costs associated with providing treatment and public safety measures relating to the epidemic from the accused companies, the Justice Department said in a statement.
"We will seek to hold accountable those whose illegality has cost us billions of taxpayer dollars," Sessions said.
Legal game changer
Having the Justice Department file as a party of interest is a "game changer," said Ohio Attorney General Mike DeWine.
"It is very, very significant," he told reporters.
DeWine noted that Ohio is one of 14 states that have filed lawsuits against opioid makers.
"The facts are that about 20 years ago, drug manufacturers decided that they wanted a much bigger market, and they went to the primary care physicians and spent hundreds of millions of dollars in advertising and focused on them to convince them that these were wonder drugs and told them at the time of that these drugs were, quote, 'not very addictive,'" DeWine said.
Pennsylvania Attorney General Josh Shapiro said law enforcement "must focus on the supply chain."
"When four out of every five heroin users start with a legal prescription drug, the supply chain runs directly to these opioid manufacturers. It runs directly to the opioid distributors," Shapiro told reporters.
Shapiro said his office was one of a coalition of 41 state attorneys general in a bipartisan effort to "make sure that we investigate the manufacturers and distributors for their role in fueling this crisis."
"I believe that these opioid painkillers have been the jet fuel to this crisis, and we have got to step up together in order to best address that," Shapiro declared.
Meanwhile, on Capitol Hill a group of eight Republican and Democratic senators unveiled new legislation to authorize an additional $1 billion in new funds to battle the epidemic. It also would increase civil and criminal penalties for drugmakers that fail to report suspicious orders of opioids or maintain effective controls against diversion of the products.
The bipartisan legislation, which would expand a 2016 law — the Comprehensive Addiction and Recovery Act, or CARA — would also impose a three-day limit on initial opioid prescriptions for acute pain.
The CARA 2.0 bill would let states waive the 100-patients-per-physician limit on using medication-assisted therapies, or MATs, such as buprenorphine, to treat opioid addiction. It would also permanently allow physician assistants and nurse practitioners to prescribe MATs under the direction of a qualified doctor.
Of the $1 billion, $300 million would go toward expanding MATs — significantly boosting the $25 million in funding allotted under the original CARA legislation.
Another $300 million would be dedicated to expanding first-responder training and access to naloxone, an opioid-overdose reversal agent.
Opioid monitoring systems
The CARA 2.0 legislation would also require physicians and pharmacists to use their state prescription drug monitoring programs, or PDMPs, when prescribing or dispensing opioids.
In addition, the PDMP measure is intended to incentivize states to provide the information from the databases to law enforcement agencies and prescriber licensing boards to better identify and cut down on hazardous prescribing habits.
The PDMP systems were the focus of a Feb. 27 Senate Health, Education, Labor and Pensions Committee hearing.
States and local governments must have reliable PDMPs to track prescriptions of opioids and other controlled substance so officials can see what is happening at the community level and doctors and pharmacists can check a patient's history with the drugs before writing or filling orders, insisted Sen. Lamar Alexander, R-Tenn., chairman of the committee.
"Data can paint a more complete picture of the opioid crisis, revealing which communities are seeing a spike in prescriptions, helping doctors avoid prescribing opioids to someone recovering from addiction, and recording the last time someone who overdosed had filled a prescription," he said.
But Alexander argued that the federal government should remain on the sidelines when it comes to building and overseeing those systems, with it playing only a supportive role.
"The federal government lacks capacity in many cases to do things well," he said.
The Tennessee Republican noted that he also co-sponsored a separate bipartisan bill earlier in February aimed at giving the National Institutes of Health a mechanism known as "other transaction authority," which would allow it to have more flexibility in researching treatments aimed at addressing the opioid crisis, like nonaddictive painkillers.
National Institutes of Health Director Francis Collins, who is expected to be among the officials at a March 1 White House opioid summit, along with HHS Secretary Alex Azar, has long asked for that authority.
Alexander said his committee was expected to consider the Senate opioid bills "as soon as the end of March."
The House is considering its own set of eight bills targeting the opioid epidemic, with lawmakers at the Energy and Commerce Health Subcommittee slated to discuss some of those measures at a Feb. 28 hearing.