Tele-Vision: How Recent FDA and SEC Actions Forecast a Sharper Focus on Telehealth Prescribing Models

Empower’s products combined these drugs with secondary ingredients like niacinamide and vitamin B12. The FDA still viewed them as essentially copies of FDA-approved products. According to the letter, the high production volume suggested the formulation differences were “pretextual.” The FDA also found that the prescriber statements meant to justify those differences were repeated word for word across many records, suggesting they were pre-generated rather than based on genuine, patient-by-patient clinical judgment. Notably, the FDA’s warning pointed to third-party technology platforms that give prescribers pre-selected menu options as an example of what can undermine that judgment.

A few weeks earlier, on August 31, the FDA and the US Securities and Exchange Commission (SEC) signed a separate three-year agreement to share non-public information with each other more routinely. The agreement is not connected to the Empower letter. But read together, the two developments point in the same direction: for companies that are also talking to investors, FDA enforcement actions like the Empower letter can create securities risk, not just regulatory risk. That is why this alert covers both.

What the FDA Warning Letter Means for Telehealth Prescribing Models

If you are in the telehealth compounder space, take note. Here is why:

• Platform design matters. The FDA specifically called out third-party technology platforms with “pre-selected menu options” for prescribers as an example of what can undermine individualized clinical judgment. If your platform shapes how clinicians make prescribing decisions, regulators may view that as undermining clinical independence.
• A small tweak does not make it legal. Adding a secondary ingredient to a compounded drug does not automatically make it a different product under federal law. The prescriber has to make a genuine, patient-specific clinical determination that the change matters. If your model relies on formulation tweaks at scale, the Empower letter makes clear that volume and templating will undercut that defense.
• Enforcement is accelerating. The FDA has stated it will use “all available compliance and enforcement tools,” and the US Department of Justice has already brought criminal charges in this area. Novo Nordisk has filed 130+ private lawsuits against telehealth companies.

What the FDA-SEC MOU Means for Telehealth Prescribing Models

The Memorandum of Understanding (MOU) does not mention telehealth by name. But we are seeing more and more health care and wellness brands exploring telehealth-driven prescribing models, and many of those same companies are raising capital or eyeing a public offering. That puts them squarely at the intersection of both agencies’ lanes.

These two agencies have been coordinating for over 20 years. The MOU makes that coordination more systematic, routine, and easy to use: designated contacts, standardized procedures, and a formal pipeline for sharing information. Warning letters, inspection findings, and compliance history can now flow from the FDA to the SEC through a streamlined channel.

If you are a public company (or plan to be), statements to the FDA and statements to your investors can now be cross-checked. This matters most for early-stage and pre-revenue companies whose valuations are tied to regulatory milestones. If your pitch deck says “FDA pathway is clear” but your regulatory file tells a more complicated story, the SEC now has a more efficient way to identify the inconsistency. The bottom line: your regulatory story and your investor story need to match, because it is easier than ever for the government to compare them. Recent experience suggests that the SEC is targeting not only biotech and pharmaceutical companies but the executives responsible for misleading statements.

What You Can Do

None of this means you cannot build an innovative telehealth company. It means the companies that thrive will be the ones that build thoughtfully from the start.

• Audit your platform design to ensure clinicians retain genuine, independent prescribing authority.
• Align your regulatory and investor narratives now, before the FDA-SEC MOU makes misalignment costly.
• Map your compliance obligations early. The FDA, Federal Trade Commission, state pharmacy boards, and SEC rules may all apply. A clear-eyed strategy makes innovation durable.
• Bring legal and regulatory counsel into the room early. The best time to design a compliant business model is before you launch, not after a warning letter or an SEC enforcement action.

If you have questions about telehealth prescribing models, compounded GLP-1 products, FDA compliance, or potential securities and disclosure considerations arising from regulatory scrutiny, please contact Abha Kundi or Matthew Berlin.