Compliance is Not a Choice: What Every Health Leader Must Know About Regulations

You've built a thriving online community. You share your health journey, your clinical expertise, and your insights with an audience that trusts you. It’s powerful, and it's making a difference. Companies are noticing, especially in the pharma world, and collaborations are on the table.

But as our collective influence grows, so does the responsibility we carry.

Recently, the Food and Drug Administration (FDA) sent a clear signal that it's paying closer attention than ever to how prescription drugs are promoted. A wave of warning letters which started in September targeted television commercials and digital ads, putting the entire industry on notice.

While this first wave focused on traditional TV advertising, we believe it’s just the beginning. The next logical step for regulators is to turn their attention to the impactful world of patient and HCP influencers.
But don’t worry! This isn't a reason to panic. It's a reason to prepare.

And this is our guide to help you not only protect yourself but also build even more trust with the communities you serve.

The "first wave": What happened and why it matters

So, what were those warning letters all about? In simple terms, the FDA reminded advertisers of a core principle: fair balance. Any promotion for a prescription drug must balance the information about the drug's benefits with information about its risks.

Regulators found that many ads were falling short by:

• Overstating efficacy: Making claims about how well a drug works that weren't fully supported by evidence.
• Minimizing risks: Using distracting visuals, fast-talking voiceovers, or vague language to downplay a drug's potential side effects.

Even though the majority of these letters targeted TV spots, the principles behind them apply to all of us. A TikTok video, an Instagram story, or a blog post that mentions a prescription product is a form of promotion. The core rules of providing a truthful and balanced picture still apply.

What’s next? Influencer marketing under the microscope

It's easy to see why the influencer world could be the next focus for regulatory focus. The line between sharing a personal story and promoting a product can often feel blurry, both for us as health leaders and for our audiences. Our power comes from authenticity, and that’s exactly why regulators want to ensure the information being shared is clear and accurate.

As they look closer at influencer content, regulators will likely be asking a few key questions:

• Is the relationship clear? Is it immediately obvious that a post is part of a paid partnership? A simple #ad or #sponsored in the beginning of your post is often the clearest way to do this.
• Are the claims accurate? Is what's being said about the product truthful, not misleading, and aligned with what the FDA has approved?
• Are the risks mentioned? Are all the risks also mentioned with the benefits.This is the trickiest part of social media. How do you include important safety information in a 280-character post or a 60-second video? Simply saying "link in bio" for safety information may not be enough.

The unique nature of our platforms presents challenges, but they are challenges we can, and must, meet head-on.

Your playbook for success: A guide to compliant and ethical engagement

Navigating this landscape successfully means shifting our mindset. Before you post, ask yourself: "Is this content truthful, balanced, and clear for my audience?"

To help, here are four pillars for creating compliant and impactful content

Pillar 1: Know the rules of the road

The FDA sets the regulations for brands when it comes to their pharmaceutical treatments, but the FTC, or Federal Trade Commission, sets the rules for influencer marketing and they have clear guidelines we must follow.

You don't need to become a lawyer, but it's wise to familiarize yourself with the basics. Look up the FTC's Endorsement Guides, the FTC’s Disclosures for Influencers Guide, and the FDA's "Bad Ad Program". These resources provide a clear look into what regulators consider misleading.

The best practice is to always ask the pharmaceutical company, agency, or 3rd party (like Health Union!) you're working with for their specific social media guidelines.

Another great resource is our Patient Leader Certification Program. In module 3 of the program, we break down the rules and regulations you need to know as a health leader. Having the stamp of certification can make you more appealing to companies looking to navigate these regulatory waters.

Pillar 2: Transparency is non-negotiable

Your audience trusts you because you're real with them. Maintain that trust by being completely transparent about your relationships with companies. Use clear disclosure tags like #ad, #sponsored, or #BrandPartner and place them where they can’t be missed (like at the very beginning of a caption).

It’s also important to note that in the FTC guidelines, it says that your disclosure must be in the same form that the content is. For instance, if you’ve created a video the disclosure must be in the video. If it’s in a live stream, you must repeatedly state the disclosure during the stream. If it’s in a photo, the disclosure must be in the photo.

Pillar 3: Content must be accurate and balanced

When you’re part of a campaign, you're an extension of the brand. It’s natural to want to share your story in your own words - that’s what makes you a powerful voice. In a highly regulated space like pharma, however, every post requires a team effort. You should work closely with the company’s medical, legal, and regulatory (MLR) review team, whose primary goal is to ensure content is safe and compliant. Their feedback isn't personal; it's protective.

While their final say is a necessary part of the process, your voice is still vital. If you feel their edits misrepresent your personal experience, speak up. The goal is always a partnership that honors your story while respecting the rules of ensuring content to be accurate and balanced.

Pillar 4: Advocate vs. testimonial

As patient leaders, our stories are our greatest asset, and we must share them authentically. The FTC is very clear: you cannot speak about a personal experience with a product you haven't actually used. So, what happens if a company invites you to partner on a campaign for a treatment you haven't taken?

This is a common and acceptable scenario when handled correctly. Your role simply is to embody the condition advocate you are and not to provide a product testimonial. You can authentically share your experience of living with or caregiving for a specific condition to connect with your community. The campaign's goal is then to guide your audience toward resources, like a patient story portal on the brand's website, where they can learn from others.

In these campaigns, your role is to be a relatable bridge, encouraging your audience to explore resources, such as patient stories on the company’s website, to learn more. You lend your credibility to the conversation, guiding others without claiming a product experience that isn't your own.

The future is bright: Building trust in a new era

This increased scrutiny is not a threat to our mission as health leaders, it is an opportunity to prove the value of our work.

By embracing transparency and balanced communication, we can solidify our position as the most credible and essential voices in healthcare. This proactive approach protects our communities, strengthens our partnerships, and deeply reinforces the trust we have built.

Let's all vow to get back to the basics and invest in self and peer education. Together, we can and will set the gold standard for responsible, patient-centered advocacy in the digital age.