Tag: FDA

Current Kratom and Psilocybin Legislative Action in Iowa

I just saw an excellent post from Dr. George Dawson, MD, DFAPA on Kratom. His emphasis that the risk for harm from this substance should be “…remembered at every policy debate.” I agree. This reminds me of what happened in the Iowa Legislature this term at the second funnel regarding substances with the potential for harms to users. Two drugs survived the second funnel: the Kratom bill House File 2133 and the Psilocybin bill House File 978, copied from the Iowa Capital Dispatch story published by Robin Opsahl, Brooklyn Draisey, and Cami Koons on March 20, 2026:

“Kratom:House File 2133 would designate kratom products – a substance currently legal for sale and possession in Iowa which produces a stimulant effect at low doses, and acts as a sedative at high doses – as a Schedule I hallucinogenic substance. People found in possession of kratom would be subject to a serious misdemeanor charge for their first offense, an aggravated misdemeanor for their second and a Class D felony charge for subsequent offenses. The bill passed the House and was placed on the unfinished business calendar in the Senate.

Psilocybin: The Senate Health and Human Services Committee amended and passed House File 978  Thursday, a bill that would allow for the legal, medical use of psilocybin in clinical environments with psychiatric support that have been approved by the state. Products with psilocybin, the psychoactive compound in “magic mushrooms,” and operators providing treatment involving psilocybin, would be regulated by the state through the Medical Cannabidiol Advisory Board, which would be expanded to include four members with expertise in psilocybin treatment. The program created through this legislation would be limited to individuals seeking treatment for post-traumatic stress disorder, but the board could seek legislative approval for using psilocybin in treatment for other mental health issues as more research becomes available.

I don’t know exactly what “unfinished business” means with respect to the Kratom bill. All I know at this stage is that it has not yet been signed into law by Governor Reynolds. I’ll have a couple of remarks about the Psilocybin bill later.

Kratom is currently legal in Iowa. A couple of years ago while we were driving on Highway 1 through Iowa City, I saw a big sign on a small store saying it was for sale. As of 12/02/2025, the FDA has issued an opinion:

“There are no prescription or over-the-counter drug products containing kratom or its known alkaloids that are legally on the market in the U.S. If a new drug application (NDA) is submitted for kratom (or one of its components) to treat a specific medical condition, FDA will review the scientific data to determine if a drug product containing kratom (or its components) is safe and effective to treat that specific medical condition. Consistent with FDA’s practice with unapproved substances, until the agency scientists can evaluate the safety and effectiveness of kratom (or its components) in the treatment of any medical conditions, FDA will continue to warn the public against the use of kratom for medical treatment. The agency will also continue to monitor emerging data trends to better understand the substance and its components.”

The web articles I found on Kratom indicate that it’s not controlled under the Controlled Substances Act, but the DEA says it’s a “drug of concern” and warns against its use according to a web article posted on March 11, 2026 by the National Institute on Drug Abuse (NIDA).

When I posted on my blog about Kratom after I saw the road sign advertising its sale at what appeared to be what we used to call a “head shop.” I tried to find more information about the substance. At that time, I found an article that saying when the DEA tried to place it on Schedule I in 2016, the American Kratom Association prevented it simply by protesting it (which may or may not be true). An historical overview of Kratom’s legal status in Iowa is here.

Kratom: Summary of State Laws

Kratom 101: What You Need to Know

As for the Iowa bill on Psilocybin, this post is getting a little long and I’ll try to keep my remarks brief. There was a news story about the bill which identified psilocybin as also being known as “magic mushrooms.” It also mentioned that it might be helpful for some people who struggle with PTSD and that last year, Governor Reynolds vetoed a bill that would have allowed distribution of the drug.

I found one of my old blog posts (“Maybe We Need a Dose of Humor) which was partly about psilocybin. I mentioned Dr. Henry Nasrallah’s article on how it might reduce the “visceral hatred” that is prominent in American politics:

In the current political zeitgeist, could psychedelics such as psilocybin reduce or even eliminate political extremism and visceral hatred on all sides? It would be remarkable research to carry out to heal a politically divided populace. The dogma of untreatable personality disorders or hopelessly entrenched political extremism is on the chopping block, and psychedelics offer hope to splinter those beliefs by concurrently remodeling brain tissue (neuroplasticity) and rectifying the mindset (psychoplasticity); September issue of Current Psychiatry, by the journal’s editor, Henry A. Nasrallah, MD (From neuroplasticity to psychoplasticity: Psilocybin may reverse personality disorders and political fanaticism. Current Psychiatry. 2022 September, 21(9): 4-6 | doi: 10.12788/cp.0283).

I found another one of my blog posts about psychedelic-assisted therapy from a couple of years ago.

The remarks from a former colleague were politely negative about the quality of the research in question in the Lykos study mentioned in my post which cited the Psychiatric Times article about the study. Dr. Jess G. Fiedorowicz, MD, PhD formerly was formerly on staff at University of Iowa Health Care. He’s now the Chief of Mental Health at The Ottawa Hospital where he’s also Professor and Senior Research Chair in Adult Psychiatry, Department of Psychiatry, University of Ottawa, Ontario. His remarks in the transcript are typical for his erudition and expertise as a clinician scientist.

And that segues into the University of Iowa Dept. of Psychiatry study on psilocybin for alcohol use disorder. There’s a podcast that mentions it with a link to an article. The department is currently recruiting according to clinicaltrials.gov:

“Psilocybin vs Ketamine for Alcohol Use Disorder: This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of ketamine.”

However, the Iowa legislature’s bill supporting psilocybin is, for now, geared toward treatment of PTSD.

I think the Kratom bill goes in the right direction and I’m not so sure about the psilocybin bill.

Update to the Iowa Legislature Bill to Make Ivermectin Available Over the Counter

Pursuant to my previous post about the debate in the Iowa Legislature over a proposed bill to make Ivermectin available over-the-counter (OTC) in Iowa, it looks as though hydroxychloroquine was recently dropped from the bill. Although few people say it out loud, in my opinion, it’s no secret that the main reason for the bill is to make ivermectin available to those who want to use it to treat Covid-19, despite there being no convincing evidence that it’s effective for that.

However, yet another bill was introduced by the governor which has its own ivermectin promotion section; so, there are now two ivermectin bills. They look the same.

The Iowa Board of Pharmacy is opposed to them because the language obliges them to comply with dispensing ivermectin to patients even if it might potentially harm them.

Although the bill removes penalties for dispensing ivermectin, there seem to be no specific penalties to pharmacists for refusing to do so. About 3 years ago, a pharmacist refused to fill a prescription for ivermectin that was intended for treatment of Covid-19.

A similar bill in Utah was not passed about 4 days ago. Supporters of the bill appeared to be engaging in passing misinformation about ivermectin for Covid-19, claiming there was “plenty of data” supporting its effectiveness for it. In fact, the FDA has not approved its use for treatment of Covid-19.

I wonder if there might be a justification for a kind of civil disobedience by pharmacists by refusing to give OTC ivermectin to patients. The other question is what does the Iowa Board of Medicine think about this? Is it right to leave physicians out of the loop in this situation?

It seems ironic that a legislator who is an internist, Dr. Austin Baeth, is on the right side of this debate by opposing the bills, yet the state medical board seems to be silent. Would it be appropriate for the state medical board to take a public position about this issue as the pharmacy board has?

CDC Advisory Committee Meeting on Vaccines Starts Tomorrow

The CDC ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) is scheduled to begin their meeting tomorrow at 10:00 AM ET despite US Senator Bill Cassidy’s recommendation that it be postponed due to concerns about the lack of experience of the committee members and because there is not yet confirmation of a new CDC Director.

In fact, the CDC Director nominee, Dr. Susan Monarez, of Wisconsin, is scheduled for her confirmation hearing at the same time as the start of the CDC ACIP meeting tomorrow morning at 10:00 AM ET. Dr. Monarez would be the first CDC director “…in decades…” (according to a report posted in The Hill in May) who has neither previously worked at the CDC “…nor obtained a Doctor of Medicine degree…”

As of this morning around 10:00 AM, the meeting agenda has not yet been finalized. So far, it looks like there will be no vote on the Covid-19 vaccine update, although there will be a vote on Thimerosal in flu vaccines about which the FDA has previously published an extensive summary.  

FDA Vaccines and Related Biological Products Advisory Committee Meeting May 22, 2025

The meeting of the FDA VRBPAC on the composition of Covid-19 vaccines will be tomorrow, May 22, 2025 at 8:30 am-4:30 pm EST. Some materials have recently become available on the FDA website.

The briefing document indicates that there will be a discussion of the most recent Covid-19 variants and whether the current vaccine needs to be modified as the viral antigenic strain has mutated.

The World Health Organization has formed a new technical advisory group: “Technical Advisory Group on COVID19 Vaccine Composition (TAG-CO-VAC) to review and assess the public health implications of emerging SARS-CoV-2 variants of concern (VOCs) on the performance of COVID-19 vaccines and to provide recommendations to WHO on proposed modifications to COVID-19 vaccine antigen composition. Recently, the TAG-CO-VAC advised that a monovalent JN.1 or KP.2 vaccines remain as appropriate vaccine antigen, while a monovalent LP.8.1 is a suitable alternative vaccine antigen (Ref: https://www.who.int/news/item/15-05-2025-statement-on-the-antigen-composition-of-covid-19-vaccines) to be included in the composition of COVID-19 vaccines (2025-2026 Formula).”

The VRBPAC meeting topics:

“On May 22, 2025, VRBPAC will meet in open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the U.S. The committee will be asked to discuss available evidence on recent and currently circulating SARS-CoV-2 variants, including data from virus surveillance and genomic analyses, antigenic characterization analyses, vaccine effectiveness and clinical immunogenicity studies of current U.S.- authorized/approved COVID-19 vaccines and nonclinical immunogenicity studies of candidate vaccines expressing or containing updated Spike antigens.”

The attendees include:

The TAG-CO-VAC presenter:

Kanta Subbarao, M.B.B.S., M.P.H. Professor Department of Microbiology and Immunology Faculty of Medicine Laval University (Laval University is in Quebec City, Quebec, Canada).

There’s an Iowa City member on the committee roster:

Stanley M. Perlman, M.D., Ph.D. Expertise: Pediatrics, Infectious Diseases Term: 08/23/2022 – 01/31/2026 Professor University of Iowa Distinguished Chair Department of Microbiology and Immunology Carver College of Medicine University of Iowa, Iowa City, IA 52242.

And the acting chair of the meeting will once again be: Arnold Monto, M.D. Expertise: Epidemiology Term: 02/01/2022 – 01/31/2026 Thomas Francis Jr. Collegiate Professor Emeritus of Public Health and Epidemiology School of Public Health University of Michigan Ann Arbor, MI 48109.

Vaccine manufacturer presentations will be from Moderna, Pfizer, Novavax, and Sanofi.

FDA Has Yet to Decide on What to Do About the Clozapine REMS Program

I checked on what the FDA is doing about changing or closing down the Clozapine REMS program. It doesn’t look like they’ve taken any action yet. Recall there was a Clozapine REMS Advisory Committee meeting about this on November 19, 2024 that I posted about recently. The upshot was that the committee voted overwhelmingly (14 yes to 1 No) to get rid of the Clozapine REMS program.

What I didn’t realize until today was that a former colleague of mine was a member of the committee. Dr. Jess Fiedorowicz, MD, PhD was on staff at The University of Iowa Health Care in the past and is now head of the Dept of Mental Health at The Ottawa Hospital in Ottawa, Ontario in Canada. I’ve included the YouTube video below of the meeting and you can find Dr. Fiedorowicz’s remarks via Zoom video at around the 8:05 or so mark into the meeting. You can view his vote to shut down the REMS program at around 8:33.

I also found out about a group called The Angry Moms (those who care for family members on clozapine) who are focused on stopping the Clozapine REMS program and one of their web pages makes it pretty clear they’re not happy that the FDA has not made a decision about REMS yet.

They mention Dr. Gil Honigfeld, PhD who I’d never heard of until now. You can tell from his T-shirt how he feels about clozapine. He has been called the “Godfather of Clozapine” and his opinion about the REMS program along with a short history of clozapine can be found at this link.

I don’t know what the FDA will do about the Advisory Committee’s recommendation, but I hope they do it soon.

Clozapine REMS Program May Go Away

The Psychiatric Times published an article about the large majority of FDA committee members recently voting to dismiss the Risk Evaluation and Mitigation Strategy (REMS) for clozapine.

That reminded me of my short post about Cobenfy, a new drug for schizophrenia. It has side effects but none of which necessitate the need for a REMS program. If you do a web search for information on Cobenfy and REMS, you can ignore the Artificial Intelligence (AI) Gemini notification at the top of the Google Chrome search page saying that “Cobenfy…is subject to a REMS (Risk Evaluation and Mitigation Strategy) due to potential side effects like urinary retention.” That’s not true.

It was yet another AI hallucination triggered by my internet search. I didn’t ask Gemini to stick its nose in my search, but it did anyway. Apparently, I don’t have a choice in the matter.

Anyway, the FDA vote to get rid of REMS for clozapine also rang a bell for me of the incredibly difficult and tedious process that the clozapine REMS registration process caused in 2015 when it was first initiated. I spent lot of time on hold with the REMS center (I think it was in Arizona) trying to get registered. A few people in my department seemed to have little problem with it, but it was an ongoing headache for many of us.

Then after getting registered, I started getting notified of outpatients on clozapine getting added to my own REMS registry list. The problem is that I was a general hospital consultation-liaison psychiatrist only—I didn’t have time see outpatients.

I think I called REMS on more than one occasion to have outpatients removed from my REMS list. I suspect they were added because their psychiatrists in the community were not registering with REMS. And then in 2021, the FDA required everyone to register again. By then, I was already retired.

Other challenges were occasional misunderstandings between the psychiatric consultant and med-surg doctors about how to manage medically hospitalized patients who were taking clozapine, or brainstorming about how to fix medical problems caused by clozapine itself. Sometimes it was connected to things like lab monitoring for absolute neutrophil counts or restarting clozapine in a timely fashion after admission or following surgeries, or trying to discharge them to facilities which lacked the resources for adequate monitoring of clozapine.

Arguably, these are probably not absolute reasons for shutting down the REMS registry. They’re more like problems with how the program is run, such as “with a punitive and technocratic approach” as expressed by one FDA committee member.

Committee members also thought psychiatrists should be allowed to be doctors, managing both the medical and psychiatric aspects of patient care.

On the other hand, some might argue that those are reasons why consultation-liaison psychiatry and medical-psychiatry training programs exist.

I’m not sure whether the clozapine registry will go away. I hope that it can be streamlined and made less “punitive and technocratic.”

FDA Approves Antipsychotic with New Mechanism of Action for Treatment of Schizophrenia

I just noticed the FDA announcment of the approval of an antipsychotic with a new mechanism of action for the treatment of schizophrenia.

The drug is Cobenfy and it interacts with cholinergic rather than dopaminergic receptors. It has a number of side effects which are anticholinergic. This could lead to psychotic symptoms that consultation-liaison psychiatrists might get called to evaluate due to the anticholinergic delirium that could occur, which can mimic psychosis.

It’s easy to get alarmed about the Cobenfy side effects. I just remember all of the side effects of the one antipsychotic that has sometimes been the only effective treatment for patients with treatment resistant schizophrenia-clozapine.

Clozapine has been associated with agranulocytosis, seizures, bowel obstruction, prolonged cardiac conduction time leading to arrhythmias, liver toxicity and more. In fact, clinicians are required to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program to prescribe it.

Patients who have schizophrenia and take clozapine are often admitted to general hospitals for treatment of medical problems which may or may not be directly related to clozapine itself. This requires close collaboration of internists and surgeons with consultation-liaison psychiatrists.

What do you do for patients who don’t respond to clozapine but are willing to take oral medication? There are augmenting strategies, some of which can be helpful although they could add to the side effect burden.

What do you do for a patient with treatment-resistant schizophrenia who refuses to take oral psychotropic medication? In some cases, it may be necessary to use injections of medications which also can have uncomfortable and even potentially life-threatening side effects. This difficult situation is complicated further by the lack of insight some patients have about their illness and the need for court orders to administer antipsychotics against their wishes.

I hope Cobenfy is a step forward for patients and their families.

Thoughts About Psychedelic Assisted Psychotherapy

I read the Psychiatric Times article “FDA Issues CRL to Lykos for MDMA-Assisted Therapy.” The short story is that the FDA essentially told the drug company Lykos that their study of the efficacy of MDMA-assisted treatment of PTSD needs more work.

I tried to wade through the on-line documents of the FDA’s meeting on June 4, 2024. There are hundreds of pages and I didn’t go through every page of the transcript. The minutes were succinct and much easier to digest.

I’m going to simply admit that I’m biased against using psychedelics in psychiatry for personal and professional reasons. I’m not a research scientist. I’m a retired consultation-liaison psychiatrist. I saw many patients with a variety of psychiatric diagnoses including PTSD and substance use disorders. I’m not opposed to clinical research in this area, but I’m aware of the difficulty of conducting it.

In that regard, I want to also admit that I’m very susceptible to being influenced by a former colleague’s remarks about the quality of the research in question in the Lykos study. Dr. Jess G. Fiedorowicz, MD, PhD formerly was formerly on staff at University of Iowa Health Care. He’s now the Chief of Mental Health at The Ottawa Hospital where he’s also Professor and Senior Research Chair in Adult Psychiatry, Department of Psychiatry, University of Ottawa, Ontario. His remarks in the transcript are typical for his erudition and expertise as a clinician scientist.

It’s difficult to wade through the pages of the FDA transcript and I couldn’t digest all of it, by any means. But if you’re interested in reading both sides of this issue, it’s a good place to get the best idea of the committee members’ thinking about it. The minutes are much easier to read and provide a succinct summary.

I realize the Psychiatric Times article editor doesn’t agree with the FDA recommendations for further study of psychedelic-assisted psychotherapy for PTSD. It may or may not influence the University of Iowa’s study of psilocybin. In my opinion, the FDA did the right thing.

FDA VRBPAC Meeting on Covid Vaccine for Fall of 2024

The voting question for today’s FDA VRBPAC Meeting on the Covid Vaccine strain for this fall is:

“For the 2024-2025 Formula of COVID-19 vaccines in the U.S., does the
committee recommend a monovalent JN.1-lineage vaccine composition?
Please vote “Yes” or “No” or “Abstain.”

The FDA Selection of the 2024-2025 Formula for COVID-19 vaccines briefing document has a thorough review on the issue.

The FDA Did Send a 252 Page Recommendation to Reschedule Marijuana

Finally, I have found a copy of the FDA recommendation to the DEA to reschedule Marijuana from Schedule I to Schedule III. The whole document is in Dropbox and is 252 pages long. The actual recommendation starts on page 62. The basis for the recommendation is three-fold:

  • Marijuana has less abuse potential other drugs in Schedule I and II
  • Marijuana has a currently accepted medical use in treatment in the U.S.
  • Abuse of marijuana may lead to moderate or low physical dependence or high psychological dependence

The third one sounds like a reason not to reschedule marijuana until you read the clarifying text, which indicates low likelihood of serious outcomes.

On the other hand, the FDA did request feedback from professional organizations on the level of concern that might lead to not recommending marijuana. Only the American Psychiatric Association had reservations against it (pages 27-28):

“FDA also considered position statements from professional organizations relevant to the indications discussed. The vast majority of professional organizations did not recommend the use of marijuana in their respective specialty; however, none specifically recommended against it, with the exception of the American Psychiatric Association (APA), which stated that marijuana is known to worsen certain psychiatric conditions.”

Further, in Iowa which has passed restricted legislation since 2017, there is disagreement about a new bill, House Study Bill 665, which would add more regulation to the sale of some hemp products. Hemp product growers are less than pleased with it. It would restrict minors from access to all hemp products, even those not containing THC. Mental health advocates, while supporting medical marijuana, are understandably concerned about the psychiatric risks attributed to cannabis, especially in adolescents.

There is a recently published paper written by Canadian authors who raise concerns about the emergency room evaluations of children in the context of marijuana exposures. (Crocker CE, Emsley J, Tibbo PG. Mental health adverse events with cannabis use diagnosed in the Emergency Department: what are we finding now and are our findings accurate? Front Psychiatry. 2023 May 25;14:1093081. doi: 10.3389/fpsyt.2023.1093081. PMID: 37304435; PMCID: PMC10247977.):

“There are more studies on the impact of cannabis on mental health in the adolescent population since our last review. One recent study using sentinel surveillance of self-harm using the electronic Canadian Hospitals Injury Reporting and Prevention Program from 2011 to 2019 showed an increase of 15.9% per year in self harm with intentional substance-related injuries exceeding unintentional injury cases and 92.3% of the cannabis-related self-harm being in the 10–19 years of age group.”

I’m ambivalent about the FDA recommendation to reschedule marijuana. On the one hand, marijuana is probably less dangerous than alcohol. On the other hand, if it’s your child that has the bad outcome related to marijuana, you’d likely be opposed to making a change.