Recent news highlights a new federal directive aimed at accelerating FDA review and research pathways for certain psychedelic therapies being explored for serious mental health conditions, including treatment‑resistant depression and PTSD.
While faster review timelines may help advance innovation in areas of significant unmet need, they also bring a more immediate strategic question for manufacturers: how do you accelerate access without creating downstream risk for patients, providers, or the product itself?
Why is safety planning so important for psychedelic treatments?
That question is particularly important for psychedelic therapies, where the treatment model may be as complex as the product. Many psychedelic therapies have known and potential safety risks that will require careful oversight to successfully treat patients in real-world settings. Compounds such as ibogaine, for example, continue to raise important questions around cardiac risk, patient selection, administration setting, and patient monitoring. Risk management must be built into development, launch planning, and post-approval strategy from the outset.
What real-world risks could affect patient access?
For manufacturers, this is not just a regulatory issue. It is a commercial and operational one. The ability to demonstrate that a therapy can be delivered safely, consistently, and at scale will play a critical role in regulatory confidence, provider adoption, patient access, and long-term market success. A product may reach approval faster, but if the supporting safety infrastructure is not fit for purpose, access can still be delayed, restricted, or undermined in practice.
What role will Risk Evaluation and Mitigation Strategies play in psychedelic therapy approval and launch?
This is where Risk Evaluation and Mitigation Strategies (REMS) and similar structured risk‑management approaches will play an increasingly important role. Historically, REMS programs have allowed regulators to balance earlier or broader access to novel therapies with safeguards designed to mitigate serious risks. These frameworks become especially relevant when treatments:
- Require controlled or supervised administration
- Are appropriate only for specific patient populations
- Demand specialized provider training or certification
- Involve ongoing monitoring, documentation, or follow‑up
Can REMS support safe use and patient access?
In the context of emerging psychedelic therapies, REMS is expected to be a critical enabler of responsible access. When designed thoughtfully, these programs can do more than satisfy regulatory requirements. They help create the conditions for safe adoption in real-world settings through standardized education, prescriber accountability, controlled settings of use, and monitoring of real‑world safety data.
While REMS programs are often thought of as barriers to access, when considered strategically instead of just tactically, they serve as mechanisms that enable access while reinforcing trust among regulators, healthcare providers, and patients.
Why does accelerated review make early risk strategy more important?
For senior leaders, the implication for psychedelic therapies is clear: accelerated review does not reduce the need for risk mitigation — it increases the importance of getting it right early. The manufacturers best positioned to succeed will be those that treat REMS and post-marketing safety strategy not as isolated compliance activities, but as core components of launch readiness, access strategy, and long-term brand performance.
How can Shepherd Safety Services at Two Labs support safer launches?
That is where Shepherd Safety Services at Two Labs (a specialized and experienced partner dedicated to comprehensive REMS and other post-marketing drug safety services) brings a different kind of value. Rather than approaching REMS as a standalone operational requirement, Shepherd helps manufacturers integrate safety strategy across the full product journey — from clinical development and regulatory planning through launch execution and post-marketing operations. This is especially important for psychedelic products, where early decisions around trial design, patient monitoring, site readiness, training, and documentation can have significant implications for post-marketing access, scalability, and commercial success.
What support does Shepherd provide for REMS and post-marketing safety?
Shepherd combines deep REMS expertise with strategic, operational, and technology-enabled support to help manufacturers prepare for the realities of real-world delivery.
That includes:
- Regulatory documentation, including enrollment forms, educational materials, and patient monitoring forms
- Strategic REMS design, contingency planning, and FDA negotiation support
- REMS program administration (i.e., website, database, contact center, and other areas of program build and operations)
- Integration of REMS requirements into product launch planning and execution for areas like patient support services, trade and distribution, medical communications, and field force training
- Phase 2 and phase 3 trial design for protocol elements that may inform future REMS requirements
Why do manufacturers need an integrated safety and access strategy?
This integrated model is what sets Shepherd apart. Unlike traditional post-marketing safety approaches often offered through CRO models, Shepherd services are designed to help manufacturers connect safety, access, and execution in a way that is more strategic, more tailored, and more commercially relevant.
Our approach combines strategic insight, operational excellence, and technology-driven solutions to create best-in-class, tailored programs that meet each product’s unique requirements, delivering measurable outcomes.
How can companies prepare now for real-world psychedelic therapy delivery?
As regulatory pathways continue to evolve for psychedelic therapies addressing complex mental health needs, the intersection of accelerated review and robust risk mitigation will remain central. Patient safety, access, and innovation are most effective when they advance together.
Manufacturers that embed safety strategy early will be better positioned not only to meet regulatory expectations, but to deliver these therapies successfully in the real world.
If you’re preparing a psychedelic therapy for approval or launch, contact Shepherd Safety Services about building a REMS strategy that supports patient safety, regulatory confidence, and real-world access from the start.
About the Authors
Melissa Landers
Founder and Vice President,
Shepherd Safety Services at Two Labs
Melissa is the founder of Shepherd Safety Services, a division of Two Labs dedicated to comprehensive drug safety strategies and services. She provides clients with extensive knowledge and experience in regulatory strategy, program management, and large-scale operations, with specialized expertise in Risk Evaluation and Mitigation Strategies (REMS).
With close to 30 years of management consulting experience, including 22 years in the biopharma sector, Melissa is recognized for her ability to solve complex challenges and implement effective solutions. Through her leadership at Shepherd Safety Services, clients benefit from an innovative, strategic partnership for REMS, Risk Management Plans (RMPs), and other drug safety programs designed to support safe use and maximize patient access to therapy.
Maggie Hoey is an Account Manager at Shepherd Safety Services, a division of Two Labs dedicated to comprehensive drug safety strategy and execution. With over 10 years of experience in the pharmaceutical industry, Maggie brings a multidisciplinary background spanning process and validation engineering, bioprocess research and development, and strategy consulting. She has deep experience supporting Risk Evaluation and Mitigation Strategies (REMS), including providing strategic input on NDA submissions with REMS requirements, supporting major and minor REMS modifications, and leading the development of REMS‑specific documentation and business requirements to support regulatory submissions and operational readiness. In her role, Maggie serves as a trusted client partner, overseeing complex project execution, coordinating cross‑functional teams, and ensuring high‑quality, timely deliverables, while also contributing to market research and analytical initiatives that inform REMS strategy and go‑to‑market decision‑making. Maggie holds a BS in Chemical Engineering and an MS in Bioscience Management and is committed to helping clients design and operationalize effective drug safety programs that balance regulatory rigor with patient access.