🛑 Psychedelic Conferences...Might Be a Bad Ad? ✋
Will "fun" psychedelic conferences be regulated under FDA advertising and drug labeling rules?
The reports I have read have been…concerning.
This isn’t about the submarine. It’s about Psychedelic Science. There have been reports…of, and I did warn about this risk, the F word.
Yes. FUN. This word is not featured in the package insert of any FDA approved medication I am aware of.
It’s problematic. Look:
One could be forgiven for imagining that MDMA had a potential FDA indication related to something other than post traumatic stress disorder, given the subject line of an email from the manufacturer of that candidate for FDA approval. I did a quick edit. “This email indicated where “the fun” might be demonstrated to be “at.” Subsequent controlled studies will evaluate the safety and efficiency data from secondary endpoints. We note the potential role of adjuvant FUN in individuals suffering from PTSD with PCL-5 scores in the moderate to severe range.”
And look:
What is this “meow wolf” of which they speak?
Is it a careful warning about adverse effects? No. Probably not. This presents some regulatory concerns.
“Advertising” includes any descriptive matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to the drug. …. Advertising is distinct from labeling in that it need not “accompany” the actual product either physically or textually.
Here, pharma executive Rick Doblin intends to get on message (from
):Doblin said he believed the FDA would approve MDMA by mid-2024, and once that happens, he said MAPS would
…and here, I am hoping he will finish with “The main adverse effects were anxiety, restlessness, fatigue, jaw-clenching, headache and transient increases in blood pressure. Serious events such as suicidal ideation were rare and occurred almost entirely in the placebo arm or were otherwise unrelated to the therapy.”
Alas, my dreams were dashed:
“We’re going to need to use psychedelics for conflict resolution,” he said, mentioning recent work bringing Israelis and Palestinians using ayahuasca together.
I sure hope the pivotal trial on ayahuasca will include a “peace in the Middle East” label…
Dear readers, I know I often write satire. This however is not a laughing matter. Pharma executives have standards to protect consumers from false or misleading claims related to safety or efficacy.
A prescription drug is considered “misbranded” if an advertisement fails to satisfy the requirements of the FDCA and FDA regulations. See 21 U.S.C. §352(n). The FDCA prohibits the introduction of a misbranded drug into interstate commerce… See id. at §331(a), (b). Further, violative advertising can be used by the FDA and other government authorities to show that a manufacturer intended a prescription drug to be used for an unapproved use, subjecting the manufacturer to potential enforcement based on distribution of an unapproved drug.
The FDA, helpfully, has an—and this is the real name—Bad Ad program to educate health care professionals and the public about advertisements that violate rules and regulations. It includes examples of violators and the subsequent regulatory enforcement letters. Let's look at one that violated the rules:
Crucially, this advertisement was only ever seen in the exhibit hall of a conference. What follows is the from letter the FDA sent in response to that ad:
Dear Ms. Vepuri:
As part of its monitoring and surveillance program, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed …(phentermine hydrochloride USP) tablets, CIV (Lomaira) that appeared in the main exhibit hall at the Endocrine Society’s 99th Annual Meeting and Expo … This panel makes false or misleading claims and/or representations about the risks associated with Lomaira and omits material facts.
And continues with the specifics of the violations:
And, I know when I shared the above ad, I prepared you by letting you know it was an example, used by the FDA, of an explicitly bad ad. But it's not obvious, if you're not a regulator, what's bad about it, until you read that very specifically they felt the lack of extensive details about all of its problems was a problem. It doesn't look that bad. Let us compare that example of a bad ad to what was being said on the stage of a sponsored pharmaceutical conference by an executive of the pharmaceutical company in question:
“We’re going to need to use psychedelics for conflict resolution,” he said, mentioning recent work bringing Israelis and Palestinians using ayahuasca together.”
It would be hard to argue that this is not advertising for their pharmaceutical product. That is what the federal Office of Prescription Drug Promotion at FDA might call an “extravagant claim.”
The FDA's Bad Ad programs education module makes this point:
“Constant vigilance over the promotional
claims of prescription medicines remains important.”
In the process of trying to change psychedelic medicines from schedule I DEA regulated substances to schedule II or III DEA and FDA regulated substances, we don't get less regulations, we get more.1
This article has a jocular tone that presents significant risks, in the use of satire. The style and font including this risk information risks minimizing these risks. Risks include: not understanding that I am a supporter of psychedelic medicine, or that I am often joking. I may be subject to ridicule, disbelief, professional consequences, and additionally, supporters of psychedelic medicine might feel that I am not cool. All of these are real and serious risks of trying to write satirical commentary about the importance of regulatory adherence when it comes to complex novel interventions in psychiatry. Please talk to your advertising executive and FDA regulatory consultant before forwarding this or any writing about pharmaceutical agents.
Well-intentioned, earnest, and passionate support for destigmatization often results in the exact opposite intended effect: frightening the mainstream population and resulting in a stigma whiplash. Non-medical psychedelic enthusiasts sometimes strongly encourage the use of a variety of different substances, and recreationally too, not simply "for medical purposes." The question becomes, "how can MAPs raise awareness with a more mainstream (non-psychedelic user) audience, without marginalizing or alienating their existing base of support?"