Neulasta FDA Advertising Compliance: An Illustration of Why Businesses Need an Interactive Website Archive | Hanzo

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

Pharmaceutical companies invest heavily in online advertisements and product websites to explain the uses, benefits, and risks of their prescription drugs. The FDA regulates these advertisements and promotional materials, but only in hindsight, as the FDA generally does not review or approve advertisements in advance. Instead, companies design and promote their ads to the public, then wait to hear if the FDA objected.

Therefore, companies must be prepared to defend their ads, or else give up the time, money and effort it took to create those ads when they are required to take them down. That’s where website archives come in. A comprehensive, interactive website archive should demonstrate exactly what the consumer saw and experienced in a video ad, promotional banner, or product website so that the company can present a full picture to the FDA when needed.

How, then, should pharmaceutical companies produce these records?

It depends on the type of ads that companies create. If a pharmaceutical ad is printed in a magazine or appears as a single still image on a website, a single screenshot is probably enough to show all of the ad’s content.

But when an ad 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 violation letter regarding Neulasta clearly illustrates.

Background: FDA Requirements for Drug Ads and Promotional Content

Most FDA advertising regulations for prescription drugs and some medical devices predate general Internet use. So they don’t give businesses clear guidance on how to stay while taking advantage of the dynamic and interactive nature of the Internet. Then companies end up with the general rules that apply to TV or radio ads.

Under these rules, product claim announcements 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 way.” Advertisements aimed at consumers rather than healthcare professionals must use “understandable language”.

This last requirement creates an unusual situation where it is not just the words of an advertisement that matter. An ad may display words that clearly describe both benefits and risks, but if certain words are bold or otherwise highlighted, displayed in a larger font, placed in the center rather than to the side or bottom, or displayed longer, these factors could influence whether the overall effect is a fair and balanced representation.

Of course, drug companies don’t always get it right. A recent example illustrates well the difficulty of describing a video or an animation with fixed images. This is where the FDA comes in, with warning and violation letters on advertisements that it deems non-compliant with the regulations.

Neulasta’s violation letter and banner ad description

A quick note: while we’re pointing to a specific ad in this article, we’re not judging anything about how that particular ad was crafted or archived or whether the ad was appropriate. We only use this recent violation letter to illustrate how difficult and stuffy it is to describe smooth, fluid animation using still images with text descriptions.

In this example, the FDA issued a Amgen Inc. Banner Ad Violation Letter for Neulasta, an injectable drug used to reduce the risk of infection after chemotherapy in patients with certain forms of cancer. Without going into specifics, the FDA alleged that “the banner makes false or misleading claims and representations about the benefits of Neulasta.”

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

  • “Text in first frame fades; a new copy slides out from the bottom of the frame and attaches next to the graphic. »
  • “The logo and text will disappear and scroll from the top of the frame as the footnote copy scrolls from the bottom, and these next two frames will start scrolling at the 27th second. They will continue to scroll beyond from the 30th second until the material is cycled through.And there will be a bar on the right for a user to go back to the blue content of those two frames.
  • “Text in first frame fades; the graphic shifts slightly as the new copy slides off the bottom of the frame and snaps into place.

Now, from these descriptions, can you tell what the advertisement actually looked like or 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 videos or animations or using interactive and dynamic elements like mouse-over text or fill-in-the-blank forms on your product websites, you need to make sure you archive the entire the customer experience.

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

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