Little-noticed law drug companies fought for: How it passed amid opioid crisis, what it does

The decision by Rep. Tom Marino, R-Pa., to withdraw as President Trump’s drug czar nominee followed exposure of one of his signature bills that, when enacted, severely handicapped drug enforcement efforts in three critical ways.

Those handicaps contributed significantly to the nation’s current epidemic of opioid addiction.

The measure, called the Ensuring Patient Access and Effective Drug Enforcement Act, passed with little debate or dissent in the spring of 2016, even as Congress and then-President Barack Obama declared opioid addiction a national crisis.

Just months before the now-notorious bill became law, Obama unveiled a federal initiative to combat the opioid crisis, saying: “This crisis is taking lives, it’s destroying families, it’s shattering communities all across the country. And that’s the thing about substance abuse – it doesn’t discriminate.”

Marino, a former county and federal prosecutor, in 2014 introduced the bill, which some federal and local officials saw as a gift to big drug distributors like Cardinal Health, McKesson and AmerisourceBergen. Many DEA officials vehemently fought the bill, according to a CBS News-Washington Post investigation. Major pharmaceutical companies campaigned for it.

Marino, who ironically represents a district that was especially hard hit by opioid overdoses, at one point argued in a House Judiciary Committee hearing that the DEA was wrong to go after drug companies as it they were “illicit narcotics cartels.”

“The mindset – it’s extremely dangerous to legitimate business,” Marino said.

On Tuesday evening, Marino issued a statement saying he withdrew because he did not want to be a distraction in the fight against the national opioid epidemic. He said the characterization of his actions regarding drug companies, and the controversial 2016 law, were distortions.

“I’m proud of my work on the Ensuring Patient Access and Effective Drug Enforcement Act of 2016, which passed with unanimous consent in the House and Senate, unopposed by the DEA and was signed into law by President Obama,” Marino said in the statement. “This landmark legislation will help to facilitate a balanced solution for ensuring those who genuinely needed access to certain medications were able to do so, while also empowering the Drug Enforcement Agency (DEA) to enforce the law and prevent the sale and abuse of prescription drugs.”

The bill – cosponsored by more than a dozen Republicans — took aim at some of the DEA’s most potent tools in going after opioid distributors shoveling vast quantities of opioid pills to sleazy pain clinics.

The final version of the bill was in large part shaped by a former DEA lawyer, D. Linden Barber, who at the time was an advocate on behalf of the drug industry. The measure rendered it virtually impossible for the government to freeze suspicious drug shipments from major pharmaceutical companies; allowed drug companies to delay or avoid enforcement action by submitting a corrective plan if the DEA finds it has acted with misconduct; and raised the bar for suspending a drug company’s license if the agency believes there is an imminent danger to the public.

At the time, the most often cited statistic reflecting the crisis was that more than 37,000 Americans died of a drug overdose in 2013, and 16,000 of them were traced to prescription painkillers.

In a Los Angeles Times interview on the bill last year, Barber said: “The fact that someone did something wrong, realized it was wrong, took action to correct it – that doesn’t give the agency the right to come in four to six months later and seek a suspension.”

The Post-CBS report said that political action committees representing the industry gave more than $1.5 million to the 23 members of Congress — Republicans and Democrats — who sponsored or co-sponsored various versions of the bill. Marino received about $100,000, the reports said.

In addition, the industry spent $106 million in efforts to lobby Congress.

The industry also recruited people who worked for the DEA and knew how to navigate the agency, the Post said. After the agency stepped up its crackdown on the industry, drug companies and law firms working for them hired at least 46 DEA officials.

DEA Chief Administrative Law Judge John J. Mulrooney II wrote in an article for a law review that the Post obtained a draft “At a time when, by all account, opioid abuse, addiction and deaths were increasing markedly,” and the new law “imposed a dramatic diminution of the agency’s authority.”

Mulrooney said the law made it impossible to shut down a drug company that was violating federal rules regarding opioids.

On Monday, a day after the Post published its story and CBS’s “60 Minutes” aired its part, Marino sent out a statement saying he had asked the Trump administration to withdraw his name for the drug czar nomination, citing an illness in his family. 

On Tuesday, Sen. Claire McCaskill, a Missouri Democrat, introduced legislation seeking to repeal Marino’s bill.

Elizabeth Llorente is Senior Reporter for, and can be reached at Follow her on Twitter @Liz_Llorente.

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