Public Comments Sought on Marijuana Rescheduling

By Pat Anson, PNN Editor

The U.S. public is finally getting a chance to comment on the federal government’s historic decision to reclassify marijuana from a Schedule I substance with a “high potential for abuse” to a less restrictive Schedule III drug with “moderate to low potential for physical and psychological dependence.”

After months of foot dragging, the Justice Department published a notice in the Federal Register today giving the public 60 days to comment on the proposed rescheduling. Written comments must be submitted or postmarked on or before July 22. Online comments can be made here.

Every step in this process has been fraught with delays. And there may be more.

The Food and Drug Administration completed a review last August – nearly a year after it was requested by President Biden -- finding “credible scientific support” for marijuana’s rescheduling. But the FDA report was not made public until January, after a lawsuit was filed by two pro-cannabis lawyers seeking its release when the agency didn’t respond to requests under the Freedom of Information Act (FOIA).

Another four months passed before the Justice Department, which oversees the Drug Enforcement Administration, submitted to the Federal Register a notice about the proposed rescheduling. Since the DEA is charged with enforcing the Controlled Substances Act (CSA) and determines how drugs are scheduled, public notices involving the CSA are almost always signed by the DEA administrator.

This one, however, is signed by Attorney General Merrick Garland, not DEA Administrator Anne Milgram – a sign that her agency is not yet on board with marijuana’s rescheduling.

“DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” Garland wrote. “The CSA vests the Attorney General with the authority to schedule, reschedule, or decontrol drugs… The Attorney General has delegated that authority to the DEA Administrator, but also retains the authority to schedule drugs under the CSA in the first instance.”

According to an Associated Press report, Milgram told her staff in March that marijuana’s rescheduling “had been taken over” by Garland and the DOJ. The DEA wanted more time for studies to determine whether marijuana has an accepted medical use, a request that was rejected.

Former DEA Administrator Tim Shea believes the rescheduling process was hijacked by DOJ for political reasons.

“If she (Milgram) had supported it she would have signed it and sent it in,” Shea told the AP. “DEA was opposed to this and the politics entered and overruled them. It’s demoralizing. Everybody from the agents in the streets to the leadership in DEA knows the dangers this brings.”   

Asked recently during a congressional hearing what her views are on marijuana. Milgram ducked the question.

“Since DEA is ultimately the decider of scheduling and rescheduling, and the DEA administrator is in that role, it would be inappropriate for me to make comments about this process or parts of that process,” Milgram said.

‘Evidence Supports Marijuana for Pain’

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – may be historic, but it’s not the full “legalization” that many cannabis supporters have been calling for.  

Under the CSA, legal access to Schedule III substances requires a prescription from a licensed doctor that is filled at a licensed pharmacy. Any new medical marijuana products would also have to go through a lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would likely only be approved by FDA for certain conditions.  

Garland’s notice in the Federal Register is largely based on the FDA’s 2023 review, which states there is good evidence that marijuana is helpful in treating chronic pain and mixed evidence it could be useful in relieving nausea, anxiety, epilepsy and PTSD.

“FDA’s review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source. The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain). Numerous systematic reviews concluded that there exists some level of evidence supporting the use of marijuana for chronic pain,” Garland wrote.

As for marijuana’s potential for abuse, Garland cited findings that marijuana poses less of a health risk than illicit drugs and even some legal medications such as oxycodone and benzodiazepines.

“The rank order of the comparators in terms of greatest adverse consequences typically ranked heroin, benzodiazepines, and cocaine first or in immediately subsequent positions, with marijuana in a lower place in the ranking,” Garland wrote.

“For overdose deaths, marijuana is always in the lowest ranking among comparator drugs. These evaluations demonstrate that there is consistency across databases, across substances, and over time. HHS thus concluded that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The opening of a public comment period does not mark the end of the rescheduling process. The DEA/DOJ will need time to review and evaluate thousands of comments, which will be followed by an administrative hearing and a final ruling that is subject to presidential review. Even then, the final rule has to be published in the Federal Register, followed by a 30 or 60-day wait period before the rule takes effect. 

During that process, and until a final rule is published, marijuana remains a schedule I controlled substance that is illegal under federal law. About three-quarters of states have already legalized marijuana for medical or recreational purposes.

Rescheduling Won’t End Conflict Between Federal and State Marijuana Laws

By Paul Armentano, Guest Columnist 

Ten months after the Biden administration requested the Department of Health and Human Services (HHS) “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law,” Secretary Xavier Becerra confirmed that the agency has recommended cannabis be removed from its Schedule I classification and placed in a lower schedule.

While the explicit details of HHS’ recommendation are not public, Bloomberg reports that the agency seeks to have cannabis moved to the less restrictive Schedule III of the federal Controlled Substances Act. 

The HHS recommendation now goes to the Drug Enforcement Administration, which will conduct its own scientific review. In the past, the DEA has employed its own five-factor test (which differs from HHS’ criteria) to determine whether or not cannabis ought to be rescheduled. On four prior occasions, most recently in 2016, the agency determined that cannabis failed to meet any of its five criteria.  

While it remains unknown at this time how the DEA will ultimately respond to HHS’ request, many are already speculating about the potential implications of such a policy change. And while some entities, particularly those involved in the commercial cannabis industry, have lauded the proposed change as a “giant” step forward, others – like myself – have been far more restrained.

That’s because reclassifying cannabis from Schedule I to Schedule III is neither intellectually honest, nor does it sufficiently address the widening chasm between state and federal marijuana laws. 

Specifically, reclassifying cannabis to a lower schedule within the CSA continues to misrepresent the plant’s safety relative to other controlled substances such as oxycodone and hydrocodone (Schedule II), codeine and ketamine (Schedule III), benzodiazepines (Schedule IV), or alcohol (unscheduled). More importantly, rescheduling marijuana fails to provide states with the explicit legal authority to regulate it within their borders as best they see fit, free from federal interference.  

To date, 38 states regulate the production and distribution of cannabis products for medical purposes. Twenty-three of these states regulate the possession and use of marijuana for adults. All of the state laws are currently in conflict with federal marijuana laws. Rescheduling cannabis to Schedule III will not change this reality. 

That’s because Schedule III substances are regulated only for prescription use by the federal government. That means legal access to these substances is limited to patients who possess a prescription from a licensed physician and who have obtained the product from a licensed pharmacy.

Currently, no state government regulates cannabis in such a manner – nor is it likely that any state will reconstruct their existing laws and regulations to do so in the future. 

Simply put, if marijuana is rescheduled, state laws authorizing citizens to possess cannabis for either medical or social purposes will continue be in violation of the federal law, as would the thousands of state-licensed dispensaries that currently serve these markets. And the DEA would still possess the same authority it has now under federal law to crack down on these state-regulated markets should it elect to do so. 

Some have suggested that rescheduling the cannabis plant may provide greater opportunities for investigators to conduct clinical research into its eventual drug development, but this result is also unlikely. That is because many of the existing hurdles to clinical cannabis research, such as the limits placed upon scientists’ access to source materials, are marijuana-specific regulations and predate cannabis’ Schedule I classification.

Other impediments, such as requiring the US Attorney General to approve marijuana-specific research protocols are statutory and are not specific to marijuana’s scheduling in the CSA. 

For these reasons, the National Organization for the Reform of Marijuana Laws (NORML) holds the position that the only productive outcome of the current scheduling review would be a recommendation to deschedule cannabis – thereby removing it from the Controlled Substances Act altogether and providing states with greater discretion to establish their own distinct marijuana policies. (A case in point: In 2018 Congress removed from the CSA hemp plants containing no more than 0.3 percent THC, as well as certain cannabinoids derived from them.)

Descheduling would remove the threat of undue federal intrusion in existing state marijuana programs and would respect America’s longstanding federalist principles allowing states to serve as “laboratories of democracy.”

By contrast, rescheduling simply perpetuates the existing contradictions between state and federal cannabis laws, and it fails to provide any necessary legal recognition from the federal government to either the state-licensed cannabis industry or those adults who use the plant responsibly in compliance with state laws.

Paul Armentano is the Deputy Director for NORML, the National Organization for the Reform of Marijuana Laws.

HHS to DEA: Marijuana Is Not Heroin

By Pat Anson, PNN Editor

The top U.S. health agency is asking the Drug Enforcement Administration to reclassify marijuana as a Schedule III drug under the Controlled Substances Act, putting cannabis in the same risk category as codeine, ketamine and steroids. Marijuana is currently classified as a Schedule I substance, the same as heroin and LSD.  

Bloomberg News was first to report that a top administrator in the Department of Health and Human Services (HHS) wrote a letter to DEA Administrator Anne Milgram asking for the change. Although 38 states and the District of Columbia have legalized recreational or medical marijuana, it remains illegal under federal law.

President Biden asked HHS Secretary Xavier Becerra nearly a year ago to review marijuana’s legal status, saying the classification of marijuana on the same level as heroin “makes no sense” and that people shouldn’t go to jail for marijuana possession.

“I can now share that, following the data and science, @HHSGov has responded to @POTUS’ directive to me for the Department to provide a scheduling recommendation for marijuana to the DEA. We’ve worked to ensure that a scientific evaluation be completed and shared expeditiously,” Becerra posted on Twitter Wednesday.

Although the Biden administration favors the move, rescheduling will not be a slam dunk. Marijuana falls under the jurisdiction of the Department of Justice, not HHS, and Milgram reports to Attorney General Merrick Garland, not Becerra. Conservative states where marijuana remains illegal are also likely to oppose the move.

Rescheduling has long been the goal of marijuana advocates, but some are disappointed that HHS is recommending it be moved to Schedule III, where it will still be regulated as a controlled substance.

“The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of US states. Rescheduling the cannabis plant to Schedule III of the US Controlled Substances Act fails to adequately address this conflict,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids. The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether.”

The DEA will now conduct its own scientific review of marijuana. On at least four previous occasions, the DEA has refused to reschedule marijuana because there were inadequate safety studies and little scientific evidence supporting its use.

Another major hurdle under federal regulations is that before a substance can be used for a medical purpose, its “chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized.” That would imply that cannabis or pharmaceutical companies would need to produce marijuana medication in measured doses that are FDA approved and only available by prescription.

There is little consistency in labeling, regulating or testing of cannabis.products sold in states where it is legal. Many products are mislabeled, with concentrations of CBD (cannabinoids) and THC (tetrahydrocannabinol) that are well above or below their label claims.

“It will be very interesting to see how DEA responds to this (HHS) recommendation, given the agency’s historic opposition to any potential change in cannabis’ categorization under federal law,” said Armentano. “Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over.”

Although nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever, professional medical associations have been reluctant to endorse its use. In 2021, the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain, citing too many “uncertainties” about the clinical evidence.

Hydrocodone Rescheduling Fueled Online Drug Sales

By Pat Anson, Editor

Hydrocodone was once the most widely prescribed and one of the most abused drugs in the United States. Over 135 million prescriptions were filled in 2012 for hydrocodone combination products such as Vicodin, Lortab and Norco.

Then in 2014 the Drug Enforcement Administration rescheduled the opioid painkiller from a Schedule III controlled substance to the more restrictive category of Schedule II. The move was intended to reduce the prescribing of hydrocodone – and it quickly had the desired effect.  By 2017, only 81 million prescriptions for hydrocodone were filled.  

But while legal prescriptions for hydrocodone have gone down, the DEA’s 2014 rescheduling may have fueled a surge in illegal online sales of hydrocodone and other opioids, according to a new study in the British Medical Journal.    

“The scheduling change in hydrocodone combination products coincided with a statistically significant, sustained increase in illicit trading of opioids through online US cryptomarkets. These changes were not observed for other drug groups or in other countries,” wrote lead author Jack Cunliffe, PhD, a lecturer in data analysis and criminology at the University of Kent.

Cunliffe and his colleagues studied these online cryptomarkets – also known as the “dark web” – by using web crawling software that scans the internet looking for websites dedicated to online sales of illicit drugs. From October 2013 to July 2016, they found that sales of prescription opioids on the dark web nearly doubled, from 6.7% to 13.7% of all online drug sales.  

“Our results are consistent with the possibility that the schedule change might have directly contributed to the changes we observed in the supply of illicit opioids,” said Cunliffe. “One explanation is that cryptomarket vendors perceived an increase in demand and responded by placing more listings for prescription opioids and thereby increasing supply.”

‘Iron Law of Prohibition’

The increase in supply and demand wasn’t just for hydrocodone. The researchers also noted a growing number of online listings for more potent opioids, such as oxycodone and fentanyl. They attribute that to the “iron law of prohibition” – banning or reducing the supply of one drug encourages users to seek more potent drugs from new sources.

“We found that users were first buying oxycodone followed by fentanyl. Drug users adapt to their changing environment and are able to source drugs from new distribution channels if needed, even if that means by illegal means. In a context of high demand, supply side interventions are therefore likely to push opioid users towards illicit supplies, which may increase the harms associated with their drug use and make monitoring more difficult,” Cunliffe wrote.

As PNN has reported, business is booming for illegal online pharmacies. As many as 35,000 are in operation worldwide and about 20 new ones are launched every day. About half are selling counterfeit painkillers and other medications. Overdoses involving fentanyl and other synthetic opioids – most of them purchased on the black market – have also increased and now outnumber those linked to prescription opioids.

"The study’s findings are troubling but not surprising. As you’ve well reported, there are often unexpected and negative externalities resulting from well-intended anti-addiction interventions," Libby Baney, Principal, Faegre Baker Daniels Consulting and senior advisor to Alliance for Safe Online Pharmacies said in an email to PNN. 

"What’s worse still, when buying medicine online - whether from dark or surface web sellers - it is virtually impossible for the consumer to know if the product is what it claims (in this case, an opioid like oxycodone) or is a dangerous counterfeit laced with a deadly dose of elephant tranquilizer or poison. As too many victims have shown, even one pill can kill."

A recent study at the University of Texas Medical Branch also found an association between hydrocodone's rescheduling and increased opioid abuse.  Researchers found that hydrocodone prescriptions for Medicare patients declined after rescheduling, but opioid-related hospitalizations increased significantly for elderly patients who did not have a prescription for opioids.

Rescheduling Hydrocodone May Have Increased Abuse

By Pat Anson, Editor

Four years ago that the U.S. Drug Enforcement Administration ordered the rescheduling of hydrocodone from a Schedule III controlled substance to the more restrictive category of Schedule II.  The move was intended to reduce the diversion and abuse of hydrocodone, which at one time was the most widely prescribed drug in the United States.

It turns out the rescheduling may have had the unintended effect of increasing the diversion and abuse of opioid medication by elderly Americans.

According to a new study by researchers at the University of Texas Medical Branch (UTMB), hydrocodone prescriptions for Medicare beneficiaries declined after the rescheduling, but opioid-related hospitalization of elderly patients increased for those who did not have a prescription for opioids.

"The 2014 federal hydrocodone rescheduling policy was associated with decreased opiate use among the elderly," said lead author Yong-Fang Kuo, PhD, a professor of Preventive Medicine and Community Health at UTMB.

"However, we also observed a 24 percent increase in opioid-related hospitalizations in Medicare patients without documented opioid prescriptions, which may represent an increase in illegal use."

Kuo and her colleagues say Medicare beneficiaries are among the largest consumers of prescription opioids. They speculated that opioid abuse by the elderly may be a coping mechanism to deal with poor health and depression, and that opioid diversion may be a sign of drug dealing.

“An economic purpose may relate to monetary gains from the diversion and sale to others,” Kuo wrote. “It is important for prescribers to understand that their elderly Medicare beneficiaries might be obtaining opioids from sources that are not documented in their medical records. There is a need for additional research on why, where, and how these Medicare enrollees are obtaining opioids.”

The UTMB research team analyzed a large sample of Medicare Part D enrollment and claims data from 2012 through 2015. Their study was published in the Journal of the American Geriatrics Society.

The reclassification of hydrocodone to a Schedule II controlled substance limited patients to an initial 90-day supply and required them to see a doctor for a new prescription each time they need a 30-day refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

In 2012, over 135 million prescriptions were written in the U.S. for hydrocodone products such as Vicodin, Lortab and Norco.  That fell to 90 million prescriptions by 2016.

Overall Opioid Prescribing Down

Hydrocodone isn't the only opioid medication to see steep declines in prescribing. The volume of opioid prescriptions filled last year dropped by 12 percent, the largest decline in 25 years according to a new report by the IQVIA Institute.  Opioid prescriptions have been falling since 2011, while dispensing of addiction treatment drugs like buprenorphine (Suboxone) and methadone have risen sharply.

“The U.S. opioid epidemic is one of the most challenging public health crises we face as a nation," said Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science.

“Our research and analytics revealed that 2017 saw new therapy starts for prescription opioids in pain management decline nearly 8 percent, with a near doubling of medication-assisted therapies (MATs) for opioid use dependence to 82,000 prescriptions per month. This suggests that healthcare professionals are prescribing opioids less often for pain treatment, but they are actively prescribing MATs to address opioid addiction."

All 50 states and Washington DC had declines in opioid prescribing of 5 percent or more in 2017, with some of the states hardest hit by the opioid crisis -- like West Virginia and Pennsylvania --  showing declines of over 10 percent. Nevertheless, the number of Americans overdosing continues to rise due to increased use of black market drugs like illicit fentanyl, heroin and cocaine, which now account for about two-thirds of all drug deaths.