While law enforcement officials are making progress reining in the misuse and abuse of legitimately marketed prescription opioids, illicit synthetic forms of those drugs, such as fentanyl and its analogues, and new psychoactive substances have been proliferating — fueling the increase in U.S. overdose deaths, a Drug Enforcement Administration official told lawmakers.
"I fear that we are witnessing a fundamental shift towards cheaper, easier-to-obtain illicit fentanyl produced in foreign countries," said Susan Gibson, deputy assistant attorney at the DEA's Diversion Control Division. "This is where the opioid epidemic converges with the synthetic drug threat."
She echoed statements recently made by Food and Drug Administration Commissioner Scott Gottlieb.
Rogue chemists creating synthetic opioids, cannabinoids and cathinone products with unknown pharmacological effects are able to stay one step ahead of law enforcement by making small tweaks in the molecular structures of their products, Gibson told members of the House Energy and Commerce Health Subcommittee at a Feb. 28 hearing.
When the DEA tries to use its emergency authority to temporarily list a product as a Schedule I controlled substance — a designation for agents with no currently accepted medical use and a high potential for abuse — drug traffickers simply slightly alter their products and sell those newer versions, stumping law enforcement, she said.
"The questionable legal status and their ever-changing chemical composition makes it difficult for federal, state and their local law enforcement counterparts to intercept these deadly substances before they hit our streets," Gibson said.
She said 1 kilogram of illicit fentanyl purchased in China for $5,000 could generate up to $1.5 million in drug proceeds in the U.S., while the "unsuspecting users of those synthetic drugs are playing Russian roulette every time they use these deadly substances."
More than 100 countries have reported the presence of synthetic drugs, and as of March 2017, about 750 substances have been reported to the United Nation's early warning advisory, Gibson said.
"This is not a U.S. problem. This is an international problem that is growing in scope," she said.
The DEA has used its emergency authority to place 56 of those 750 "designer" drugs, including 17 fentanyl analogues, temporarily on the Schedule I list.
On Feb. 6, the DEA temporarily placed Schedule I controls on the entire class of fentanyl-related substances "in an unprecedented effort to curb the disturbing trend in fentanyl-related overdose deaths," Gibson said.
"DEA believes all fentanyl analogues belong in Schedule I," she said.
Not legal alternatives
While fentanyl and its analogues are scheduled substances under the Controlled Substances Act, the man-made, new psychoactive substances generally are not.
"It is a massive problem," Gibson said.
She said many people, particularly teenagers, believe those designer agents are legal alternatives to controlled substances. But, Gibson said, they are like taking methamphetamine and phencyclidine, or PCP, at the same time.
"These products are killing our kids," Gibson declared. "These people are peddling death."
She said a bill sponsored by Rep. John Katko, R-N.Y. — the Stop the Importation and Trafficking of Synthetic Analogues Act, or SITSA — may help the DEA get a better grasp on the situation.
The SITSA legislation is aimed at modernizing the Controlled Substances Act by creating a mechanism by which synthetic analogues could be temporarily or permanently added to a new schedule in as little as 30 days after the chemical composition is determined.
It also would ban 13 synthetic fentanyl products identified by the DEA as an immediate threat to the nation's public health.
In addition, the bill would impose steep penalties on foreign manufacturing and importation and would add to the current law an offense for falsely labeling controlled substance analogues.
Gibson noted that many of the illicit synthetic products that make their way into the U.S. are produced in China, with much of them coming in directly through private couriers or mail carriers or alternatively shipped to transnational criminal organizations in Mexico, Canada and the Caribbean using mail carriers or parcel delivery services.
But she praised the Chinese government for scheduling 138 of the new psychoactive substances, which she said helps U.S. law enforcement efforts.
"China has been a good friend to us," Gibson said. "We are really appreciative for anything the Chinese government can do in regulating substances."
Drugmakers' role in the epidemic
But Rep. Kathy Castor, D-Fla., among other lawmakers, emphasized that legitimate drugmakers have played a large role in driving the opioid crisis through their marketing practices.
Castor asked if the DEA planned to comply with a federal judge's recent request to release certain government-collected transaction data in an Ohio lawsuit filed against manufacturers and distributors.
She noted that under the Controlled Substances Act, manufacturers and distributors must report their controlled substances transactions to the Automation of Reports and Consolidated Order System, or ARCOS.
The ARCOS database shows how many pills were sold, where in the U.S. they were shipped and what pharmacies bought the products, Castor noted.
But Gibson said her office was under a statutory obligation to "protect business proprietary information."
She said the DEA was trying to work something out with the parties in the Ohio suit but could not say if the agency would comply.
Castor noted the DEA had until next week to comply with court or face the judge's threat of releasing all of the ARCOS data about the companies involved in the lawsuit rather than a limited amount.
The DEA has opposed making the data public for fear it could jeopardize a number of other U.S. government lawsuits and investigations involving opioid makers.
As part of its effort to curb the opioid epidemic, the U.S. Department of Justice on Feb. 27 revealed it planned to file a so-called statement of interest in a lawsuit against a number of drug manufacturers and distributors accused of using false, deceptive and unfair marketing practices.