Rep. Tom Marino (R-PA), President Donald Trump’s pick for drug czar, hadn’t gotten a single hearing from the Senate yet. But Trump had already hinted on Monday that he would consider taking Marino out of the running if he thought Marino’s role in a law’s passage was “1 percent negative to doing what we want to do.”
Then, on Tuesday, Trump made it official: He tweeted, “Marino has informed me that he is withdrawing his name from consideration as drug czar. Tom is a fine man and a great Congressman!”
The news came after a bombshell report from the Washington Post and 60 Minutes that looked at Marino’s involvement in a law passed in 2016: the so-called Ensuring Patient Access and Effective Drug Enforcement Act.
The law made it very difficult, if not impossible, for the US Drug Enforcement Administration (DEA) to stop suspicious shipments of opioid painkillers by drug distributors, according to an upcoming law review article by DEA Chief Administrative Law Judge John Mulrooney.
Under federal law, distributors must report and stop suspicious orders of some drugs, including opioids. In the past, the DEA has fined companies for not doing so and, in some cases, frozen shipments, leveraging a section of the Controlled Substances Act that let the agency stop orders that it believed posed an “imminent danger.”
But Marino’s law changed this. It raised the bar to require that shipments pose “a substantial likelihood of an immediate threat” to be stopped. Joe Rannazzisi, former head of the DEA’s Office of Diversion Control, argued that this has essentially created an impossible standard — a claim backed by Mulrooney’s upcoming law review article.
“There’s no way that we could meet that burden, the determination that those drugs are going to be an immediate threat, because immediate, by definition, means right now,” Rannazzisi told the Post.
The law also requires the DEA to give drug companies a chance to submit “corrective action” plans and take those plans into account before the agency can sanction them. Mulrooney wrote that this is akin to a law that requires police to “allow bank robbers to round up and return inkstained money and agree not to rob any more banks — all before any of those wrongdoers actually admit fault and without any consequence that might deter such behavior in the future.”
This hindered the DEA’s ability to go after irresponsible opioid distributors — even as the drugs they helped spread across the US caused a drug overdose epidemic that kills tens of thousands of Americans every year and that Marino would have been in charge of combating as drug czar.
Marino’s law stifled DEA attempts to go after opioid distributors
The House backed Marino’s bill in 2015, but it didn’t become law until 2016. The final version came after Sen. Orrin Hatch (R-UT) worked with the Department of Justice and DEA, which opposed the original bill, to get to language that they could sign on to. After some language tweaks and leadership changes at both the Justice Department and the DEA, the revised bill passed both houses of Congress through “unanimous consent” — not even a formal vote tally — and President Barack Obama signed it into law.
Marino took credit after the final measure’s passage. In a press release, he said the law will ensure “our drug enforcement agencies will have the necessary tools to address the issue of prescription drug abuse across the country.” (Marino’s office did not return my request for comment. His office also did not return requests for comment by the Post or 60 Minutes, and called Capitol Police when reporters from the outlets showed up at his office to ask about the law.)
As Marino and other supporters of the law put it, the measure was necessary to stop the DEA from taking overly punitive actions that made it difficult for patients to get drugs, such as opioids, that they needed.
“We had a situation where it was just out of control because of [Rannazzisi],” Marino told the Post last year, referencing the head of the DEA’s Office of Diversion Control at the time. “His only mission was to get big fines. He didn’t want to [do] anything but put another notch in his belt.”
Supporters of the law say the DEA had been so aggressive that it had scared drug companies away from cooperating with the agency. Instead of letting the DEA take immediate action against companies, the new law — through the higher burden of proof and requirement for “corrective action” plans — forces a slower process that gives companies a greater chance to respond. And that might make companies more proactive in reporting and stopping bad shipments, since they’ll know that it won’t necessarily get them into trouble.
Supporters also argue that the law helped settle legal uncertainty that could have blown up the DEA’s efforts. The Controlled Substances Act didn’t define “imminent danger.” D. Linden Barber, a former DEA lawyer who now works for the drug distributor Cardinal Health, argued to Congress that drug companies could take advantage of the previous law’s vagueness to halt the DEA’s mission.
“Indeed, many of my colleagues believe that the [Walgreens] case would have resulted in a narrowing of DEA’s authority if the agency had not settled its dispute,” Barber said, referring to a case in which Walgreens argued in federal appeals court that the law was too vague (but later settled with the federal government, agreeing to an $80 million fine). “As a supporter of DEA’s mission, I urge this committee to take legislative action that clarifies the meaning of ‘imminent danger.’”
Critics, meanwhile, argue that Marino’s law makes it impossible for the DEA to stop irresponsible distributors’ shipments. Mulrooney wrote, “If it had been the intent of Congress to completely eliminate the DEA’s ability to ever impose an immediate suspension on distributors or manufacturers, it would be difficult to conceive of a more effective vehicle for achieving that goal.” (Even before the law, however, the Post reported that outside pressure from drug companies on the Justice Department had already led such orders to drop: from 65 in fiscal year 2011 to eight in fiscal year 2016.)
This could not only stop the DEA from blocking dangerous shipments but also remove a deterrent that may have stopped drug companies from acting irresponsibly before.
There’s also the question of Marino’s motives. According to the Post, Marino has received nearly $100,000 in donations from political action committees tied to the drug industry. And last December, Marino’s chief of staff and “point man” on the law, Bill Tighe, became a lobbyist for the National Association of Chain Drug Stores.
Tighe’s career move represents the kind of revolving door from Congress and the DEA to opioid distributors that helped shepherd Marino’s bill into law. In emails obtained by the Post, Barber was credited with writing the measure. He was the former associate chief counsel for the DEA before he became a lawyer at law firm Quarles & Brady, where he represented drug companies, and then an executive at Cardinal Health.
Following the report by the Post and 60 Minutes, some members of Congress have moved to repeal Marino’s law. Sen. Claire McCaskill (D-MO) introduced legislation that would do just that. But Sen. Orrin Hatch, at least, has stood by the law, arguing that the report was an attempt “to derail the president’s nominee to be head of the Office of National Drug Control Policy, Rep. Tom Marino, by mischaracterizing and trying to rewrite the history of a bill that he championed.”
There’s a reason the DEA targeted drug companies in the first place: These companies really were doing some suspicious things. For example, a previous investigation by the Charleston Gazette-Mail in West Virginia found that from 2007 to 2012, drug firms poured a total of 780 million painkillers into the state — which had a total population of about 1.8 million. The small town of Kermit, West Virginia, had a population of 392, but a single pharmacy there received nearly 9 million hydrocodone pills over two years from out-of-state drug companies.
Critics of opioid companies argue that these kinds of shipments were obviously suspicious and should have been stopped. They’re a key explanation for why West Virginia now leads the country in drug overdose deaths: The proliferation of opioid painkillers got people addicted to the drugs, in some cases putting them on a path to other opioids like heroin and fentanyl. And critics like Rannazzisi argue that drug companies let this all continue as they pursued higher profits.
“This is an industry that’s out of control,” Rannazzisi told 60 Minutes. “What they wanna do is do what they wanna do, and not worry about what the law is. And if they don’t follow the law in drug supply, people die. That’s just it: People die.”
As drug czar, Marino could have played a major role in addressing the epidemic
As drug czar, Marino would not have overseen the DEA. He would have been in charge of the White House’s Office of National Drug Control Policy (ONDCP), which tries to coordinate and guide the many federal agencies and programs that are involved in the war on drugs. In this role, he would have served as a top adviser to Trump on drug policy and related issues — particularly the opioid epidemic.
In the past, the office has been highly focused on illegal drugs, like cocaine and heroin; the position of drug czar was created by President Richard Nixon during a past heroin epidemic in the 1970s, and it was made permanent and official through the Anti-Drug Abuse Act of 1988, during the crack cocaine epidemic. The focus has changed in recent years as the country deals with an opioid epidemic that began with the proliferation of legal painkillers.
Typically, the office sets the tone of the federal drug war. In ONDCP’s first national drug control strategy, President George H.W. Bush and drug czar Bill Bennett drew a clear set of priorities: In the table of contents, the first item for “National Priorities” is “The Criminal Justice System,” not treatment or prevention.
“It was a culture war document,” David Courtwright, a drug policy historian at the University of North Florida, previously told me. “It’s very much a statement about personal responsibility, zero tolerance, directed law enforcement to crack. It was very much a drug war document.” He added, “In terms of actual impact on policy [and] media coverage, it’s a very big deal in the late ’80s.”
The office also advises the White House and Congress on drug policy, particularly in setting priorities for the many federal programs addressing drugs and addiction.
Whether that leads to actual policy changes, though, depends wholly on whether the president and Congress actually accept the drug czar’s advice — since the office itself does not have much direct power in terms of changing policy.
ONDCP “is in an advisory capacity,” Courtwright said. “If you go back and look at the national drug control strategy documents, they make suggestions. They prioritize programs. … But do they actually set policy? I guess they do if the president and Congress say it’s a good plan and do it.”
The history suggests that Congress and the president do tend to follow what the drug czar says on drug policy. Based on Marino’s record, that could have led to a federal government that adopted a softer approach toward opioid companies, despite the harm they caused in the past.
The federal government has a big role to play in tackling the opioid crisis. Congress could dedicate a lot more money to drug addiction treatment and harm reduction strategies, such as making the overdose antidote naloxone more accessible. The Food and Drug Administration could impose stricter regulations and oversight on opioid painkillers. Public health agencies could help train doctors to adopt better practices in prescribing opioids. (Read much more on these potential moves in Vox’s in-depth explainer.)
Marino could have advised the president on all of this and more.
This is particularly important to Trump, because his base has been hit hard by the opioid crisis. A previous analysis of the election, for example, found that most Ohio and Pennsylvania counties that flipped from Obama in 2012 to Trump in 2016 had some of the highest opioid overdose death rates. It’s statistics like these that put pressure on Trump to get this issue in particular right.
So after the Washington Post and 60 Minutes raised new questions about Marino’s credibility on opioids, he apparently became too much of a liability for Trump. And now Marino is out.