Legislators have mixed views on whether to classify fentanyl as a schedule I substance

Regulatory NewsRegulatory News | 06 December 2021 |  By 

Members of the House Energy and Commerce’s Subcommittee on Health heard testimony 2 December from a US Food and Drug Administration (FDA) official urging congressional support of an administration plan to permanently place fentanyl in the most restrictive category allowed under the Controlled Substances Act (CSA). 
The plan addresses the “pressing need” of the public health crisis posed by fentanyl and its related compounds by placing them by default into schedule I, though lawmakers also recognize the therapeutic value of the potent opioids and the need for ongoing research into fentanyl and related compounds.
Fentanyl and its related compounds have been temporarily classified as schedule I substances under the CSA, and a stopgap funding bill approved by Congress on 2 December to avert a shutdown includes an order that would leave them in that category until 18 February 2022.
Other schedule I substances, such as heroin, lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (also known as ecstasy), have no currently accepted medical use and are unsafe with a high potential for abuse. When injected, fentanyl is approximately 300 times more potent than oral morphine, meaning that very small fentanyl doses can result in fatal respiratory depression. Its lethality, combined with its high abuse potential, have made fentanyl and related compounds serious contributors to opioid-related deaths in the US.
Legislators noted the devastating impact that fentanyl is having on their communities. “More than 100,000 Americans have died of drug overdoses since the COVID pandemic began,” said subcommittee chair Anna Eshoo (D-CA). “The grim record shows no sign of abating. The vast cause of the overdose deaths is due to synthetic opioids such as fentanyl.”
“It is hard to find anyone who has not been impacted by this,” concurred Rep. John Curtis (R-UT).
The Biden Administration in early September proposed that Congress permanently place fentanyl and its related substances in the schedule I category.  The proposal would establish a streamlined process to align research for all schedule I substances, including fentanyl related substances (FRS), more closely with the research registration process for schedule II substances. Under the proposal, the Department of Health and Human Services would also oversee a streamlined process to identify and remove or reschedule from schedule I any individual FRS that is found not to have a high potential for abuse.
The proposal was drafted with the input of FDA, the Drug Enforcement Administration, the National Institutes of Health, and the Office of National Drug Control Policy, who all voiced their support for the proposal, saying that permanently placing fentanyl on the schedule I list would combat the opioid epidemic by providing law enforcement with the tools they need to rapidly respond to the threat posed by illicit fentanyl products. Representatives of these agencies testified in support of the plan at the hearing.
Why research?
After hearing prepared testimony, Eshoo questioned the witnesses on why there is a need to conduct research on fentanyl. “I don’t quite understand the need to study fentanyl, we already know what it does. It is not clear to me. Everyone has stated how devastating fentanyl is… what is it that we don’t know about this?” she asked.
FDA’s Douglas Throckmorton, deputy director for regulatory programs at the Center for Drug Evaluation and Research, told Eshoo there are some clinical benefits associated with some fentanyl compounds that have been studied. “The DEA shares the data that they collect on the FRS class with FDA. We have looked at a group of over 25 FRSs and we have studied their pharmacology,” said Throckmorton.
For example, he said, one compound has been found to have “no activity to turn on the opioid receptor,” meaning that this FRS may be able to reverse the overdose effects of fentanyl. “This substance would have the potential to treat fentanyl-use disorders or reversing overdoses. That is what we learn as we will study these individual compounds.”
The proposal “would appropriately balance the pressing need to address the public health risk posed by the illicit use of some of these compounds and the similarly important need to support scientific research into these substances to develop new therapies and improved scientific understanding,” added Throckmorton. “We feel the interagency proposal strikes an appropriate balance between these two priorities and is deserving of your consideration.”
Mixed views expressed about proposals
Some legislators expressed caution about placing fentanyl in schedule I as some of these compounds are routinely used for pain management in hospitals.
Rep. Kim Schrier (D-WA) said that while fentanyl has had a “profound impact on our community” she added that in her experience as a physician, these compounds are also used in hospitals as treatments for pain management and for other uses.
Nora Volkow, the director of NIH’s National Institute on Drug Abuse, said that “fentanyl, if used as an anesthesia, has many advantages when used properly. It is when it is illicitly manufactured that it is a problem.”
Rep. Tony Cardenas (D-Calif) said that he is opposed to placing fentanyl permanently into schedule I.  “It takes the approach that you are guilty until proven innocent. Banning these compounds based on their chemical structure could have an effect on biomedical research.”
Volkow responded that “we are not in an ideal world. We are in an emergency situation.”
Yet other legislators, including Rep. Neal Dunn (R-FL) and Rep. John Joyce (R-PA), supported the proposal to place fentanyl into Schedule I. “This is a grave and important matter … Congress cannot allow this life saving order to expire,” said Joyce.
House Subcommittee hearing on fentanyl
Administration proposal on fentanyl


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you