Complying With the FDA’s Advertising Regulations: Why You Need an Interactive Website Archive

| October 5 2021

Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising

The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it generally only works reactively, after advertisements have been created and circulated. For pharmaceutical companies, that creates a dilemma: while they strive to create ads that they believe conform with regulations, they also have to be ready to provide those ads to the FDA—and pull them from circulation—if they’re called into question. 

Most biotech and drug companies are aware that they need to archive their websites to satisfy the FDA’s requirements, but they may not realize that any old archive won’t do. 

Let’s take a closer look at the FDA’s advertising regulations, what online pharmaceutical advertising includes, and why companies need an interactive website archive. 


The FDA’s Regulations About Online Advertising

The FDA only regulates advertising for prescription drugs and certain medical devices. (Over-the-counter medications are regulated, of course, but by the Federal Trade Commission, not the FDA.) 

There’s a bit of a wrinkle, though: the FDA’s advertising regulations don’t directly address the internet. Most of the guidance around advertising predates the general use of the internet, so it doesn’t tell companies exactly how they should respond to social media comments or otherwise leverage the interactive nature of the internet. The FDA has tried to plug some of those gaps by creating draft guidance documents, but those are incomplete solutions that haven’t, at any rate, been adopted as final. 

Still, the rules on prescription drug advertising that apply to TV or radio ads also apply to banner ads, online video ads, and product webpages. Under those rules, ads must

  • include the drug’s generic name and at least one approved use, 
  • avoid any false or misleading statements, 
  • communicate at least the most significant risks associated with using the drug, 
  • present the benefits and risks of a prescription drug in a balanced fashion, and
  • be written in clear language that the general public can understand. 


Because companies can’t emphasize the benefits of a drug or downplay its risks, the layout and presentation of ads are important. Headlines, type size, bullets, and the amount of white space around text all matter when it comes to determining whether the ad meets the FDA’s fair balance requirement. 


Online Drug Advertisements Need to Be Archived

Pharmaceutical companies, like most industries, rely heavily on the internet to promote their products. In the case of prescription drugs, companies use online ads and product information pages to:  

  • advertise and promote their products, 
  • educate the public about specific health conditions and their treatments for those conditions, 
  • answer consumers’ questions, 
  • communicate the full risks of their drugs and devices, and 
  • promote their drugs and devices. 


Everything you see online about a prescription drug or device—from the product’s dedicated website or information page to banner ads, online video ads, social media pages or ads, and promoted search engine results—equates to online advertising that must comport with the FDA’s stringent requirements for advertising. 

In most situations, though, the FDA notes that “Drug companies must only submit their ads to us when they first appear in public... This means that the public may see ads that violate the law before we can stop the ad from appearing or seek corrections to the ad.” When the FDA does hear complaints about an ad, it can issue a violation letter, demanding that the company respond and/or suspend the ad. 

That’s where internet archives become important—but static archives like screenshots leave a lot to be desired. 


Why Companies Need an Interactive Website Archive

Suppose that the FDA contacts your company about an advertisement or product page that’s currently live on your website. At that point, it’s fairly easy to disprove or explain the alleged violation. You can go to the live site, demonstrate how it functions, and show how you’ve presented the necessary disclaimers, evidentiary support, and a balanced view of the risks and benefits of the drug or device. 

But what if you’ve changed your site and you no longer have the contested content on it or no longer have it in that format? What if the violation letter comes after you’ve already stopped running an ad? Or what if the violation letter only includes screenshots that don’t give a full and fair view of your advertisement?

Screenshots and other static archiving methods present only a moment in time—and sometimes that moment isn’t a reasonable representation of the whole advertisement. That’s especially true with video content and interactive content such as mouse- or hover-over text. It may be that your advertisement included all necessary disclaimers and risk statements, but they’re only visible when a customer interacts with the ad itself. 

That’s why companies need to have functional, interactive website archives that they can use to prove that their advertising and promotional content is and was in compliance with regulations. 

As they say, though, a picture is worth a thousand words—so in our next blog in this series, we’ll walk through a recent example of a violation letter from the FDA, including the attached screenshots “representing” the ad, to demonstrate how screenshots fall short. 

Ready to check out a fully interactive archiving solution for your pharmaceutical company’s website or your products’ individual pages? Hanzo Dynamic Capture is the data preservation and archiving solution trusted by experts in the financial, technology, energy, pharmaceutical, and life sciences industries. We’ve been helping companies maintain regulatory compliance, protect their intellectual property, and prepare for litigation for years. 

Hanzo Dynamic Capture doesn’t just create a static archive; it crawls the entirety of a source website, locating and capturing every piece of content, including advertisements, disclosures, and evidentiary support. Hanzo then creates a replica website that can be navigated as if it were live, allowing users to manipulate interactive text and charts, replay videos, and even explore links.

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If there’s an aspect of your advertising or regulatory compliance that you’re concerned about, Hanzo’s archives will help you investigate and capture it. Contact us to schedule a demonstration.



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