Health

ED Docs Split Over Fentanyl Analogue Schedule 1 Extension

Emergency physicians clashed over lawmakers’ decision to extend the classification of all fentanyl-like drugs as Schedule 1 controlled substances.

President Biden on Tuesday signed legislation to temporarily extend the Trump-era order until Oct. 22, 2021. (The order was slated to expire on May 6.)

Proponents say the order helped law enforcement prosecute drug traffickers, but criminal justice reform advocates oppose the extension, because Schedule 1 drugs require mandatory minimum sentences, which would lead to more incarcerations and exacerbate racial disparities in prison.

Public health opponents of the measure argue that it is overly broad, and that substances with no psychoactive effects could be placed on Schedule 1 by mistake without any input from HHS experts, including researchers at the National Institute on Drug Abuse and the FDA.

More than 100 stakeholder groups, including AIDS United, the Drug Policy Alliance, Human Rights Watch, and the National Health Care for the Homeless Council, sent a letter to lawmakers in early April urging them not to pass the extension.

The Senate passed the extension unanimously on Thursday and the House passed it by a voice vote last month.

In 2018, the Drug Enforcement Administration (DEA) enacted a temporary scheduling order that classified all fentanyl-like substances as Schedule 1 drugs, grouping them with other drugs like heroin and LSD, which have a high potential for abuse and “no currently accepted medical use.”

In a speech prior to the House vote, Chairman of the House Energy and Commerce Committee Frank Pallone (D-N.J.), called the scheduling of fentanyl-related substances “an important deterrent to traffickers, manufacturers, and those distributing this substance.”

Regina LaBelle, JD, acting director for the White House Office of National Drug Control Policy (ONDCP), clarified the Biden administration’s position during an April 14 hearing of a health subcommittee for the House Energy and Commerce Committee.

LaBelle said the administration was calling on Congress to extend scheduling for “a short period of time.”

At the same hearing, Rep. Cathy McMorris Rodgers (R-Wash.) said that without the order, every new fentanyl analogue triggered a “game of whack-a-mole for drug control efforts,” forcing the DEA to individually schedule each variant. Extending the order, she said, would allow the DEA to place “any dangerous variant” under Schedule 1.

When Rodgers pressed LaBelle about whether her office would seek a more permanent solution, LaBelle said the ONDCP would review a recent Government Accountability Office (GAO) report on the policy, required by prior legislation, and then work with HHS, DEA, and the Department of Justice on a “whole-of-government approach” to the issue.

In a speech on the House floor prior to the chamber’s vote, Rodgers begrudgingly agreed to support the bill, saying she was “gravely disappointed” that the extension would last only a few months; she urged both Republicans and Democrats “to begin working immediately on a longer-term solution.”

Public Health Impacts

The American College of Emergency Physicians applauded the bill.

“ACEP appreciates that the temporary extension will give Congress time to thoughtfully consider measures that impact access to controlled substances such as fentanyl and its analogues. Emergency physicians welcome a chance to inform policies that strive for balance between appropriate pain management strategies and necessary patient and public health protections,” an ACEP spokesperson wrote in an email.

Tim Westlake, MD, an emergency physician in Oconomowoc, Wisconsin, and the immediate past chair of the state’s Medical Examining Board, who also testified before the House Energy and Commerce Committee Health subcommittee, on April 14, also supported the extension.

Westlake noted that he had helped develop and implement language for the fentanyl scheduling reform policy in Wisconsin in 2017, which was later adopted by the DEA in 2018. He argued that the scheduling reforms closed a loophole that drug cartels used to create and illegally distribute fentanyl analogues.

After a friend’s son, Archie Badura, died of an overdose at age 19 in May 2014, Westlake called for implementing the scheduling reforms.

Westlake, who was working on the Controlled Substances Board in Wisconsin at the time, said he found many different fentanyl variants that were legal.

“So we came up with this idea that if you make targeted fentanyl-related substances reform, those chemical companies and those drug companies will stop making those, which is exactly what happened,” Westlake told MedPage Today, in a phone call.

“Now is not the time to eliminate a proven harm-reduction and overdose prevention strategy,” he said at the hearing.

More than 87,000 people died from drug overdoses in the 12 months ending in September 2020, according to the CDC’s preliminary data.

Scheduling a ‘Distraction’

But others working in emergency medicine and working for criminal justice reform opposed the measure.

“Since this bill was first introduced under the Trump administration … we have only seen deaths from fentanyl increase, and what’s more troubling is that we’ve seen harsher penalties on … low-level drug dealers who are either selling or using drugs,” said Ryan Marino, MD, an emergency physician and a medical toxicologist at Case Western Reserve University School of Medicine in Cleveland.

“Fentanyl and fentanyl analogues are already illegal,” which makes the bill “a distraction” as well as a “policy failure,” he said.

Grant Smith, deputy director of national affairs for the Drug Policy Alliance, argued that the extension doesn’t reduce overdose deaths, but instead undermines public health.

People who are using drugs are less likely to call for help when they’re witnessing an overdose if they are worried about being arrested, Smith said.

In addition, knowing that trace amounts of fentanyl could lead to a long prison term might discourage people using or selling drugs to remain ignorant of a substance’s fentanyl content, believing that will make them “less culpable,” Smith added. “The bottom line is that the same penalty applies across the board,” and as more people using and selling drugs begin to understand that, the more harmful the public health impacts will be.

Smith also argued that because fentanyl-related substances can be more potent than fentanyl, “it’s even more important that we have a health-based approach, that we not stigmatize people by criminalizing them.”

Alternative Strategies

Another witness at the April 14 House hearing, Patricia Richman, JD, national sentencing and resource counsel for the Federal Public Defender’s Office for the District of Arizona, said she disagreed with the “key purported benefit” of advocates of the legislation — i.e., stopping novel fentanyl-like substances from entering the community.

What’s clear, said Richman, is that bans don’t decrease supply.

Methamphetamine has been illegal since the ’70s, and today “it’s coming into the country in greater quantities and purity than ever before,” she said. Decades of an “enforcement-first approach” have shown that such strategies don’t promote public health nor do they reduce overdose deaths, Richman added.

Smith said that instead of escalating enforcement, the Biden administration should be focusing on efforts to close the treatment gap, and to increase harm-reduction strategies, “giving people tools to stay alive” and connecting them with those who can help them make positive changes in their lives.

Marino also argued that Congress should focus instead on changes supported by the science and the evidence, including decriminalization and legalization, while acknowledging, however, that his views are “several steps ahead” of others on this issue.

Other less controversial strategies and more “meaningful” changes would include expanding access to naloxone, by making it available over-the-counter, and expanding recovery resources, he said.

“At the end of the day, if people want to make drugs on the street … as safe as possible, then decriminalization and having a standard supply or a regulated supply would be the end game,” Marino said.

Criticism Off-Base

Westlake told MedPage Today in a phone call that it was “disingenuous” for critics of the legislation to say it isn’t working; overdose deaths continue to rise “because deaths are going up from other substances, from other opioids,” he said.

In 2016 and 2017 in Florida, 2,500 people died from fentanyl-related substances, and in one district of New York City there were 900 deaths from fentanyl-related substances in 2 years “and now that’s not happening any more,” Westlake said. But “if you look at the overdose statistics on new fentanyl-related substances, there’s essentially zero now.”

The legislation doesn’t stop the flow of fentanyl from Mexico, but it does stop chemical companies and cartels from developing new variants, he noted. “There are all these specific structural pathways that are known, and what they would do is just take one little chemical modification on that molecule … and they would switch it and then it would be legal, and then they could sell it. So what this [bill] did, was … stopped those companies from making that.”

In other words, “the specific targeted purpose of the fentanyl-related scheduling language has worked,” Westlake said, noting that overdoses on new fentanyl-related substances have “ground to a halt.”

And while the legislation is being portrayed as a “failed Trump policy,” it has strong bipartisan support, Westlake added. “In 2018 and 2019, every single Democrat attorney general [signed it], including [now HHS Secretary] Xavier Becerra twice — he signed a letter asking Congress to enact this legislation permanently.”

Implications for Research

Another criticism of the legislation is that extending class-wide scheduling would prevent meaningful research.

One point Richman tried to emphasize is that fentanyl and fentanyl analogues are different substances and that not all fentanyl analogues are harmful. “Fentanyl analogues can be potentially thousands of substances,” she explained. “Some of those might be more harmful than fentanyl. Some of those might have no impact in the human body at all.”

Some may even be helpful, she added.

The GAO report on fentanyl analogues acknowledges that some fentanyl-related substances “may include medically useful substances or ones with low abuse potential.” The report highlighted how remifentanil, a Schedule II opioid painkiller used in surgeries would have been swept up under the temporary scheduling order.

Researchers are beginning to find analogues that could have the potential to treat opioid use disorder, “which deserve investigation,” and the extension would hamper that kind of research, Richman said.

Westlake, however, panned that argument: “The fact is that in the extensive research that’s been done in 60 years, not one antagonist that has a fentanyl class structure has ever been found, nor has one medication-assisted treatment ever been found,” he said.

  • Shannon Firth has been reporting on health policy as MedPage Today’s Washington correspondent since 2014. She is also a member of the site’s Enterprise & Investigative Reporting team. Follow

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