The Justice Department is urging Congress to rewrite legislation, passed at the pharmaceutical industry’s behest, that has undermined the Drug Enforcement Administration’s efforts against companies suspected of violating the law.
Assistant Attorney General Stephen E. Boyd wrote in a letter Wednesday that the Justice Department seeks to bring the law “more in line with the original intent of Congress,” according to a copy obtained by The Washington Post.
Boyd was responding to Rep. Greg Walden, (R-Ore.), chairman of the House Energy and Commerce Committee, which is investigating the opioid industry.
“We believe the changes will make it easier to fight the opioid epidemic consistent with President Trump’s priorities to end this crisis,” said Justice Department spokeswoman Sarah Isgur Flores. The bill was approved by Congress and signed into law by President Barack Obama.
Walden, who asked for the agency’s input last year, said Friday that he would consider amending the legislation.
“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,” the chairman said. “We appreciate their guidance and are actively working with DOJ and stakeholders to address their concerns.”
Walden has sponsored several measures to address the opioid epidemic, and he plans to hold a hearing this month about the DEA’s enforcement efforts against the industry.
The Ensuring Patient Access and Effective Drug Enforcement Act was pushed through Congress in 2016 by a small band of lawmakers backed by a powerful array of drug companies. The legislation was the subject of a joint investigation by The Post and “60 Minutes” in October.
The initial version was written by a drug industry attorney who once worked for the DEA. It was sponsored by Rep. Tom Marino (R-Pa.). Sen. Orrin G. Hatch (R-Utah) negotiated a final version of the bill in the Senate, and it was signed by Obama in April 2016.
“While it would have been easier if the department had made these suggestions when I was working with them on the bill, before it sailed through Congress without objection and was signed into law by President Obama, I plan to study the department’s proposal closely,” Hatch said Friday. “It’s important for policy in this area to properly balance law enforcement and patient needs.”
In a statement Friday night, Marino said: “DOJ and DEA have finally articulated what changes they would like to see in regards to the Ensuring Patient Access and Effective Drug Enforcement Act. While I still stand by my legislation that was supported by every senator, congressman, the DEA, the DOJ, and signed into law by President Obama, I look forward to working with DOJ and my colleagues to improve the law to ensure the DEA has every tool at their disposal to put an end to the opioid epidemic.”
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 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, have called for its repeal.
Boyd, the assistant attorney general, sent his letter to Congress the day after Sessions announced 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 has filed 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, saying that the federal government has borne substantial costs.
Since the passage of the law, DEA agents and investigators have said it neutered their most potent weapons against drug companies that fail to report suspicious orders of prescription painkillers from pharmacies. The DEA’s chief administrative law judge, John J. Mulrooney II, also wrote in a law review article that the law crippled the agency’s enforcement efforts.
By amending the Controlled Substances Act of 1970, the law made it almost impossible for the DEA to use immediate suspension orders against drug distributors, according to the judge’s law review article. Those orders allowed the DEA to instantly stop shipments of controlled substances to drugstores suspected of diverting prescription narcotics to the black market.
Rather than show that those shipments posed an imminent danger to a community, the new law required proof that the shipments posed a “substantial likelihood” of an “immediate threat” of death or bodily harm. The judge and others said it would be impossible to prove that standard against large drug manufacturers and distributors.
Boyd called for changing that standard to “probable cause”— a threshold that is “relatively immune from varying court interpretations.”
Industry officials defended the 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. The industry also complained that the DEA communicated poorly with companies and was too punitive when narcotics were diverted from the legal distribution chain to users and dealers.
Another provision allows companies to submit “corrective action plans” that the DEA must consider before bringing sanctions. The DEA judge equated this to allowing bank robbers to return stolen cash after being caught.
Boyd said the corrective action plans should be stricken, saying the DEA has a process that permits companies to present their cases as part of administrative proceedings.
Since 2000, more than 200,000 people have died of prescription drug overdoses — more than three times the number of American lives lost during the Vietnam War.
Lenny Bernstein contributed to this report.