GLP-1 therapies are transforming obesity and chronic disease treatment, yet navigating their complex regulatory landscape remains critical. From the Food and Drug Administration’s ‘Green List’ to state-specific rules, compliance isn’t optional – it’s a strategic advantage.
In a recent webinar, McDermott Will & Schulte’s Health & Life Sciences Group explored strategies for scaling GLP-1 programs, covering topics like innovative care delivery models, direct-to-consumer advertising enforcement, and compliance best practices.
GLP-1 therapies represent both a transformative opportunity and a complex regulatory challenge. They are reshaping the way obesity and chronic disease are treated, opening doors for innovative care delivery models that promise improved patient outcomes. At the same time, the regulatory environment is highly fragmented, requiring careful attention to federal FDA rules as well as state-specific variations in prescribing and reimbursement.
Ultimately, success in this space requires organizations to align clinical innovation with legal and regulatory compliance. Companies that stay ahead of evolving FDA guidance, adapt to changing state laws, and build sustainable compliance frameworks will be best positioned to thrive. The panel emphasized that investment in compliance infrastructure is not simply a legal safeguard, but also a strategic enabler for scaling GLP-1 programs.
Key discussion points included:
GLP-1 Background and Clinical Applications
FDA-approved GLP-1 drugs are approved for several clinical indications including obesity, type 2 diabetes, and reducing cardiovascular risk. Emerging research suggests certain GLP-1 drugs can also be beneficial for off-label uses, such as substance use disorder, alcohol use disorder, polycystic ovary syndrome (PCOS) care, and autoimmune disease care. However, practitioners should be aware of how varying laws may impact off-label prescribing.
FDA’s ‘Green List’ for GLP-1 APIs
The FDA has introduced a ‘Green List’ import alert to ensure that only GLP-1 Active Pharmaceutical Ingredients (APIs) from FDA-vetted international manufacturers are allowed into the US market. This measure is intended to maintain the safety and quality of GLP-1 drugs’ API originating overseas. APIs from sources not on the ‘Green List’ are subject to detention without physical examination, preventing potentially unsafe or low-quality products from reaching patients.
State-specific regulations
Providers must be aware of and comply with state-specific regulations that impact the prescribing and reimbursement of GLP-1s for weight loss. For example, in Alabama, an in-person assessment is required before issuing a refill for non-controlled substances used for weight reduction. In Louisiana, only FDA-approved GLP-1s for weight loss can be prescribed, and providers must ensure that these drugs are used for their approved indications. Understanding these laws is essential for avoiding legal issues and ensuring proper payment for services.
Innovative care delivery models
Innovative care delivery models for GLP-1 drugs offer opportunities to improve accessibility, affordability, and patient outcomes, but require careful regulatory compliance. These models include synchronous and asynchronous patient evaluations, telehealth and telemedicine for remote prescribing, and partnerships with Pharmacy Benefit Managers (PBMs) and pharmacies. When exploring innovative care delivery models, it is important to understand the patchwork of laws and requirements around issues such as patient consent, maintaining thorough record keeping, coordinating care, and ensuring follow-up care.
FDA enforcement on Direct-to-Consumer (DTC) advertisements
The FDA is actively monitoring and cracking down on misleading DTC) advertisements, especially those that claim compounded drugs are equivalent to FDA-approved drugs or are clinically proven without proper evidence. Stakeholders should be cautious of such claims and ensure messaging is aligned with the FDA’s guidance. This enforcement helps ensure that patients receive accurate information about their options.
Compliance Best Practices
To navigate this evolving landscape, companies should adopt a risk-based compliance framework that covers prescribing practices, marketing, dispensing, and patient engagement. This means implementing clear protocols around state-specific prescribing rules, compounding restrictions, and telehealth standards. A strong emphasis should also be placed on protecting patient privacy and data security, particularly when digital health platforms are involved.
Compliance cannot be treated as a one-time exercise but must be built into the operational culture of an organization. Regular provider and staff training ensures that those on the front lines understand the latest requirements and are equipped to apply them in practice. In addition, leadership should prioritize compliance audits and proactive monitoring to identify and address issues before they escalate, particularly as the enforcement landscape continues to develop.
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