On Tuesday, senators raised their concerns at a hearing with a representative from the Drug Enforcement Administration (DEA), arguing that the agency has been “hamstrung” by a law passed in 2016. At the same time, lawmakers warned that the lax enforcement by the DEA has allowed the pharmaceutical industry to profit from the deadliest drug addiction crisis in the nation’s history.
“I’m convinced pretty much that this bill is not the right thing to do, that it has hamstrung the DEA,” Sen. Diane Feinstein (D-Calif.) said of the 2016 law imposing new limits on the DEA’s ability to suspend suspicious drug shipments.
“I believe it’s well enough known that there’s an overabundance of opiates, it’s well enough known that the companies are making a lot of money from opiates, and the DEA ought to take a most conservative position now and really go after people who abuse or violate the law,” Feinstein continued.
At issue is the 2016 Ensuring Patient Access and Effective Drug Enforcement Act (EPAEDEA), a bill passed unanimously in the House and Senate and then signed into law by President Barack Obama. At the time, the bill was aimed at improving patients’ legitimate access to drugs, like opiates, that are carefully monitored under the Controlled Substances Act. Prior to the passage of the law, thousands of pharmacies and drug manufacturers were complaining about stopped drug shipments, which inconvenienced patients and business.
However, months after the bill’s passage, the DEA’s chief administrative law judge, John Mulrooney II, wrote in a Marquette Law Review that the new EPAEDEA imposed a new, heavy burden on drug enforcement, making it more difficult for the agency to suspend suspicious drug shipments and prevent drugs from pouring into America’s streets.
“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,” Judge Mulrooney wrote.
Both The Washington Post and “60 Minutes” picked up on the new legislative impediment to combating the overprescription crisis. In October, The Washington Post reported that under the new law, “Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets.”
Moreover, the Post asserted that the law made it “virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies,” a standard that ensured the pharmaceutical industry could continue selling billions of dollars worth of prescription drugs without the threat of law enforcement disrupting their supply lines.
In testimony on Tuesday, the DEA’s Acting Assistant Administrator for the Diversion Control Division, Demetra Ashley, affirmed Mulrooney’s concerns, telling lawmakers that “the DEA along with the Department of Justice supports a change in the legislation.”
Prior to the passage of the law, the DEA was able to preemptive stop the shipment or distribution of prescription opiates that they believed would be diverted into unlawful channels and abused, she explained. Under the current law, they essentially have to wait until an individual has been hurt or killed to stop the drug companies from making a suspicious shipment.
“Prior to the legislation we were in the preventive mode,” she said. “The current legislation requires that we establish a ‘substantial likelihood’ of immediate death, bodily harm and abuse.”
While she was reluctant to discuss the exact changes DEA wanted to see, Ashley told lawmakers that the agency would like to “continue using the legislation as it previously was, to prevent” the diversion of drugs.
Lawmakers on both sides of the aisle were open to legislative changes that would better allow DEA to prevent drug abuse, but others were outraged at the failure of U.S. drug enforcement to staunch the flow of drugs into communities across the country.
According to Sen. John Kennedy (R-La.), the problem is much bigger than fixing a statute. “When 14 billion pills are being distributed and we only have 323 million Americans, that tells me that’s 41 pills per person for every man, woman and child in America. And that is absurd,” Kennedy stated.
As the opioid epidemic was reaching its height, the DEA was allowing pharmaceutical companies to produce a record number of pills. In 2014, the agency was allowing manufacturers to produce nearly 160,000 kilograms of Oxycodone and over 80,000 kilograms of Hydrocodone, or approximately 14 billion pills. In recent years, the DEA has significantly lowered its production quota for prescription opiates. In 2017 and 2018, the DEA cut prescription drug quotas by more than 40 percent from their peak and expects the cuts to continue in 2019.
Despite the DEA cutting back on the number of pills prescribed to Americans, Kennedy is not convinced that the DEA has the tools it needs, nor is it using the tools it has to effectively combat the opioid epidemic. “I don’t know what the problem is with DEA, except I know they’re not succeeding. That’s clear.”
Sen. Amy Klobuchar (R-Minn.) is among the Democrats calling for a complete repeal of the statute so the DEA can preemptively block drug diversions and impose real costs on drug manufacturers.
“This is the tobacco issue of our time,” Klobuchar said. “You have a situation where a number of these manufacturers have literally gotten people hooked … and that companies were not being straight with doctors, with hospitals and mostly with regular citizens about the incredibly addictive nature of these products.”
That issue has prompted 41 state attorneys general to band together to investigate how the drug industry promoted the use of prescription opiates. It has also prompted hundreds of drug-ravaged counties, cities and towns to file lawsuits against drug manufacturers.
Sen. Claire McCaskill (D-Mo.) insisted that drug enforcement officials “don’t have the tools they need,” and argued that her bill to repeal the statute and allow the DEA to preemptively stop suspicious drug shipments will help empower the agency and fight the drug scourge.
“There’s a lot of lip service about opioids around this building,” she said, “but now is an opportunity for us to give the DEA the tool it really needs.”
The opioid epidemic was responsible for the deaths of more than 33,000 Americans in 2015. More than 15,000 Americans died from an overdose of prescription opiates. In recent months, the presidential commission on opioid abuse reported that this addiction crisis did not start in the streets, but in doctor’s offices and hospitals around the country.
One of the most egregious cases of drug overprescription occurred in Kermit, West Virginia, a town of fewer than 400 residents. Over the course of two years, a single pharmacy in that town received 9 million prescription pain pills, enough drugs for every man, woman and child to have 31 pills every day for two years, or approximately 22,500 pills per person.
“Nobody can look at those numbers without realizing there’s a problem there,” said Sen. Patrick Leahy (D-Vt.). “The manufacturers are making a huge amount of money, but people are dying.”
Leahy further expressed concern that the DEA either lacks the tools to combat the opioid epidemic or it has failed to effectively use the tools it has available.
A number of lawmakers stood behind the decision to pass the bill, including its chief author in the Senate, Orrin Hatch (R-Utah), and in the House, Rep. Tom Marino (R-Penn.).
Back in October, Marino was under consideration to become President Trump’s Drug Czar and serve as the head of the White House Office of National Drug Control Policy. However, Marino withdrew his nomination after The Washington Post and “60 Minutes” reported on his central role in crafting the Ensuring Patient Access and Effective Drug Enforcement Act.
In a statement issued on Tuesday, the congressman argued against the veracity of the media reports which claimed Marino, Hatch and the bill’s other sponsors were receiving large campaign contributions from the pharmaceutical industry. “I have been involved with and supported law enforcement throughout my life. I would never introduce or support legislation that would make it easier for dangerous drugs to proliferate,” Marino said.
Hatch argued that the criticism of the bill has been “deeply frustrating,” saying the reports failed to take into account the problem of supply chain disruptions reported by a large number of legitimate patients and providers.
“This wasn’t some effort to help drug companies kill people,” Hatch asserted. “This was an effort to ensure DEA’s praiseworthy effort to stem abuse don’t end up hurting legitimate patients.”
