By Vincent Joralemon
Psychedelic companies and advocacy groups are spending substantial resources to influence regulatory policy, shaping what the blossoming field will ultimately cohere into.
Although regulations are designed to protect the public interest, the rulemaking process is often dominated by lobbying from those with special interests in the fields meant to be regulated. When that leads to undue influence, the result is known as “regulatory capture.”
Yet, not all lobbying campaigns are necessarily problematic — the goal instead should be for regulators to leverage industry insights while maintaining independence in their ultimate decision-making.
What is Regulatory Capture?
The concept of “regulatory capture” was codified over fifty years ago in George J. Stigler’s The Theory of Economic Regulation. Stigler argued that the government’s main “resource” is the “power to coerce,” and therefore a rational interest group would seek to convince the government to use its coercive power for the group’s own benefit.
There are plenty of upsides to this. It makes sense for a company to push for regulations that help their business, and organizations often have a lot better knowledge than policymakers about how to regulate their own industries efficiently.
But, it is helpful to keep incentives in mind here. If an entity exists in a state that is bound to impose regulatory restrictions, the ideal constraints will be:
- as friendly to their own interests as possible; and
- as unfriendly to their current and future competitors’ interests as possible.
A company could always try to stay out of conversations about governmental policies, but that risks having their concerns ignored. If you can shape these regulations, why not do so in a manner that benefits you?
This brings us to the burgeoning psychedelic sector, which has quickly expanded from the margins to accumulate substantial industry investment. With this, we’re seeing active lobbying from stakeholders in the psychedelic realm on everything from telehealth to “psychedelic” definitions to research guidelines. But the most pertinent lobbying is currently working to shape the FDA’s guidelines for psychedelic therapy.
FDA Psychedelic Draft Guidance
When administrative agencies propose new guidelines or rule changes, companies, trade groups, academics, and engaged citizens reply with specific concerns. This makes sense — if a policy change will affect you, you probably want a say in how it is implemented.
So, when FDA issued draft guidance of “considerations” for psychedelic drug developers earlier this year, the public posted 227 comments in response. Reading through those statements highlights nuanced lobbying efforts from several organizations in the psychedelic realm (big thanks to the people over at Psychedelic Alpha for putting together this phenomenal analysis).
For example, MAPS Public Benefit Corporation pushed for “some form of psychological intervention made available before, during, and after the dosing sessions” for better safety and efficacy. This tracks with MAPS’ mission; they just submitted a New Drug Application for MDMA-assisted therapy to treat PTSD. Their product is not a strict pharmaceutical treatment (i.e., “MDMA”). Instead, their whole model is based on taking MDMA in conjunction with psychotherapy (i.e., “MDMA-assisted therapy”). So, it makes sense that MAPS pushed for that component to be a mandatory part of psychedelic treatments.
Conversely, MAPS’ competitor COMPASS Pathways petitioned FDA to distinguish between “psychedelic-assisted psychotherapy” and “the administration of a psychedelic compound in combination with psychological support.” This aligns well with their COMP360 psilocybin treatment, where clinicians are primarily present to “safeguard” patients rather than guide them through psychotherapy. So, COMPASS wants therapy decoupled from psychedelic treatments.
Neither argument is necessarily problematic. For MAPS, they seem to really believe that therapy is linked to the psychological benefits of MDMA; their PTSD and anorexia clinical trials both require a therapy component. For COMPASS, the psychedelic is doing the heavy lifting; their depression, PTSD, and anorexia clinical trials prioritize the drug’s direct action rather than therapeutic interventions. Some evidence suggests therapy is an important piece of psychedelic treatment, but because therapy is such an expensive component of MAPS’ model, COMPASS’ strategy may end up saving a lot of money for patients and insurers. So, there are advantages and disadvantages from both angles.
In short: to MAPS, MDMA and therapy are a package deal; to COMPASS, the drug is the primary product. Their statements merely nudge FDA toward their respective points of view. The important thing is for FDA to analyze these comments with their own scientific lens independently — and for policymakers to give the agency the resources to do that competently.
Takeaway: It’s Not All Bad
In case you missed it, I don’t think psychedelic lobbying is necessarily problematic. A considerable number of the most dominant voices here seem to have fairly genuine concerns about safely expanding access to psychedelics. Ostensibly, these organizations have extensive industry expertise; why not leverage that insight to inform regulations? The more nascent the industry, the more it makes sense for those with insider wisdom to help shape policy — and psychedelics are just beginning to emerge as a substantial market.
It is helpful to recognize that when an organization pushes for regulation in one direction, it can have detrimental effects on others. The most important thing is for regulators to remain as unbiased as possible so they are equipped to analyze these requests independently. There are several ways to do this:
- Institute unbiased or “independent” organizational bodies to determine standards of care.
- Create “shielding” ethical rules for regulators who have industry backgrounds or connections.
- Establish oversight for lobbying efforts by former FDA employees.
- Listen more to recommendations from truly independent review boards within agencies.
With these, we can allow all the procedural benefits of psychedelic lobbying without sliding into the problematic outcomes associated with psychedelic “regulatory capture.”
