Neulasta FDA Advertising Compliance: An Illustration of Why Companies Need an Interactive Website Archive

| January 27 2022

If a picture is worth a thousand words, what’s a video worth? 

Pharmaceutical companies invest heavily in online advertisements and product websites to explain their prescription medications’ uses, benefits, and risks. The FDA regulates those ads and promotional materials, but only in hindsight, as the FDA doesn’t typically review or approve ads in advance. Instead, companies design and promote their ads to the public and then wait to hear whether the FDA has taken objection to them. 

Companies, therefore, need to be prepared to defend their ads—or else discard the time, money, and effort it took to create those ads when they’re required to retract them. That’s where website archives come into play. Complete, interactive website archives should exactly demonstrate what the consumer saw and experienced in a video ad, promotional banner, or product website so the company can present the full picture to the FDA when needed. 

How, then, should pharmaceutical companies produce those archives? 

That depends on what type of ads companies are creating. If a pharmaceutical ad is printed in a magazine—or appears as a single still image on a website—then a single screenshot capture is likely adequate to show everything contained within the ad. 

But when an advertisement consists of a video or an animated banner, a still image doesn’t capture everything. Even a series of still images doesn’t tell the whole story—as the FDA’s violation letter concerning Neulasta clearly illustrates. 

 

Backdrop: The FDA’s Requirements for Drug Ads and Promotional Content

Most of the FDA’s advertising regulations for prescription drugs and certain medical devices predate the general use of the internet, so they don’t give companies precise guidance about how to remain while leveraging the internet’s dynamic and interactive nature. Then, companies are left with the general rules that apply to TV or radio ads. 

Under those rules, product claim ads for prescription drugs can "name a drug and discuss its benefits and risks," but they "must not be false or misleading in any way." Perhaps most importantly, ads "must present the benefits and risks of a prescription drug in a balanced fashion." Ads directed at consumers rather than health professionals should use "understandable language."

This last requirement creates an unusual situation where it isn’t solely the words of an advertisement that matter. An ad can display words that clearly describe both benefits and risks, but if some words are bolded or otherwise emphasized, displayed in a larger font, placed centrally instead of to the side or bottom, or displayed for longer, those factors could influence whether the overall effect is a fair and balanced depiction. 

Naturally, pharmaceutical companies don’t always get it right. One recent example is a good illustration of the difficulty of describing a video or animation with still images.  That’s where the FDA steps in, with warning and violation letters about advertisements that it believes aren’t in compliance with the regulations. 

 

The Neulasta Violation Letter and Banner Ad Description

One quick note: while we’re pointing to a specific ad in this article, we’re not judging anything about how this particular ad was designed or archived or whether the ad was appropriate. We’re only using this recent violation letter as an example of how awkward and stilted it is to describe a smooth, flowing animation using still frame images with text descriptions. 

In this example, the FDA issued a violation letter regarding Amgen Inc.’s banner ad for Neulasta, an injectable drug used to reduce the risks of infection after chemotherapy in patients with certain forms of cancer. Without getting into the details, the FDA alleged that “The banner makes false or misleading claims and representations about the benefit of Neulasta.” 

To establish its case, the FDA referred readers not to an animation showing the ad itself but instead to a series of still images with descriptions of what the full animated version looked like. For example, the FDA’s descriptions note: 

  • “First frame text fades out; new copy slides in from bottom of frame and fixes into place next to graphic.”
  • “Logo and text fade out and scroll out of top of frame as footnote copy scrolls in from the bottom, and these next two frames will start to scroll at the 27th second. They will continue to scroll past the 30th second point till the material has run through. And there will be a bar at the right for a user to go back on the blue content on these two frames.”
  • “First frame text fades out; graphic shifts up slightly as new copy slides in from bottom of frame and fixes into place.”

 

Now, from these descriptions, can you tell what the ad really looked like or whether it presented a fair and balanced portrayal of the drug in question?

 

Your Website Archives Should Be as Good as Your Website

Screenshot archives are probably perfectly adequate if your ads and promotional materials consist exclusively of still images—the equivalent of print ads. But if you’re creating video or animations or using interactive and dynamic elements like mouse-over text or fillable forms on your product websites, you need to ensure that you’re archiving the complete customer experience. 

That’s why companies need to have fully functional, interactive website archives that they can use to prove that their advertising and promotional content was and is in compliance with regulations. Otherwise, how will you respond if the FDA sends you a violation letter that relies on screenshots that don’t give a full and fair view of your advertisement?

The solution already exists: 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 users can navigate as if it were live, manipulating interactive text and charts, replaying videos, and even clicking through links. 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.

 

Related posts

Compliance Archiving Features for Advanced CMS

Compliance Archiving Features...

Often, a compliance team may have an archiving solution in place, only to discover their archives aren’t capturing ...

Read More >
Five Healthcare Litigation Trends For 2022: An Upcoming Discussion with Jon Braunstein, Partner at Dentons

Five Healthcare Litigation...

Healthcare is a highly innovative, lucrative, and regulated industry, which also makes it a highly litigious industry. ...

Read More >
Why Not Just Retain Everything In Slack?

Why Not Just Retain...

Remember the early days of email when there was such a thing as a clean and organized inbox? I remember I would even ...

Read More >

Get in Touch to Learn More

Hanzo’s purpose-built, best-in-class solutions can help your readiness to respond to the next discovery request, investigation, or audit. Contact us to learn more.

Contact Us