FDA-2023-D-1987

An Urgent Call To Action to Include Nurses in Psychedelic Therapy Research

You may have heard that the FDA has proposed guidance for future research studies in psychedelics and that these guidelines, if adopted as written, could have significant impact on the ability of nurses to participate in research studies. While these guidelines are nonbinding, they often create precedent that is carried forward in future rules and policies. As such, it’s important to act now to see that nurses are well represented in psychedelic treatments

We've created a Q&A and we encourage you to read the guidelines themselves here (click on the “Download the Draft Guideline Document, the parts most relevant to nurses are on pages 9-10).

So, what are they saying about nurses?

The FDA recommends that studies continue to use two monitors (they are not using the term “therapist”). They are recommending that the only kind of nurse who could be a lead monitor would be a graduate trained, psychiatric nurse practitioner (PMHNP). No other nurses could be lead monitors under this guidance.

They go on to say that the assistant monitor could be any person with a bachelors degree and 1 year of licensed mental health experience.

I have an ADN (Associates Degree in Nursing), what does that mean for me?

You would not be able to work on psychedelic studies as a bachelor’s degree is required to be an assistant monitor.

I’m not a psych nurse. I work in palliative care or in the ED. What does this mean for me?

You would not be able to work on psychedelic studies because the current guidance would require an assistant monitor to have 1 year of experience in a licensed mental health setting.

I’m an oncology NP or CRNA. What does this mean for me?

You would not be able to be the lead monitor on a psychedelic study. If you have 1 year of experience in a licensed mental health setting, you may be eligible to be an assistant monitor.

I’m not planning on working on a research study. I’m waiting for after FDA approval to start doing this work. Why should I care about this document?

Early guidance documents such as this often create precedent for future rules and regulations. Additionally, if a wider range of nurses is not allowed to work on studies now, it will be more difficult to argue that nurses have the experience and skills needed to provide this care when it is deployed in clinical settings, outside of research in the future.

In short, the psychedelic ship is getting ready to sail, and if nurses want to be on it, we need to act now.

That doesn’t seem right. What can we do?

The FDA has proposed this guidance. As a federal agency, they are tasked with making the rules and issuing guidelines. This is different from congress passing laws. The FDA has not yet issued this as final guidance.

Until August 25, 2023 they are welcoming comments from the public providing feedback about these rules. Comments from others are visible here if you want to get an idea of what others have already said.

I’ve never commented on a federal proposal. What should I say?

Consider sharing a little bit about your training and background and how these proposed rules would impact your ability to provide this care.

This will be especially important for those of you who do not work in mental health nursing, such as L&D nurses, heme-onc, and palliative care nurses, who would be excluded if this goes through. If you are a ASN trained nurse, point out that despite your experience, you would not be able to provide psychedelic care under these guidelines

Remember, these comments are public and will have your name attached to them, so it would be unwise to speak of personal experiences with psychedelics that are outside the law. You do have the ability to post anonymously. Keep the tone professional, so that it reflects favorably on the high status that nurses have in the public eye.

There may be other aspects of the guidelines that you wish to comment on. You are welcome to do that as well, in addition to sharing your concerns around the restrictions on nurses.

While it’s important to advocate for yourself, it’s often more powerful if you can frame your comments to discuss how these limitations will impact equitable patient access to psychedelic treatments. For example, if you are a palliative care nurse in a rural area, describe how if you are restricted from providing this care, your patients with life-threatening illnesses will not have access to an important treatment.

Your statement need not be long. It’s more important to post something, even if it’s short and thoughtful, than to let this opportunity pass by.

Won’t OPENurses be advocating for the inclusion of nurses in psychedelic studies?

Yes, but there is additional strength in numbers. If the FDA gets hundreds of comments from nurses, they will need to pay attention to this issue. You can see the OPENurses organizational response here, but we need a grassroots response from nurses across the country, as well.

Ok, I’m convinced. What do I need to do?

Go here - https://www.regulations.gov/document/FDA-2023-D-1987-0002 and click on the “comment” button. Select “an individual” and type in your comments. In your comments, reference “Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry – Docket: FDA-2023-D-1987”

When considering what to write, consider reflecting on these questions, as they apply to you:

a) What kind of work do you do, and how do you see psychedelic treatments potentially helping those patients?

b) If ASN nurses were excluded from psychedelic studies, how would that impact you and the patients you treat?

C) If non-psych nurses were excluded from psychedelic studies, how would that impact you and the patients you treat?

D) If only PMHNP's were allowed to be lead monitors on psychedelic studies, how would that impact you and the patients you treat?

E) If you are in one of the groups that would be excluded from providing psychedelic treatments, how would your inability to participate in psychedelic treatments negatively impact your patients and your community?

If you wish, you can mail your comments instead (otherwise, web submission is fine):

Dockets Management Staff (HFA–305),

Food and Drug Administration,

5630 Fishers Lane, Rm. 1061,

Rockville, MD 20852.

If you are willing, please copy and paste your comments in an email to openurses@gmail.com Thank you for participating in this important process!