Complying with FDA Advertising Regulations: Why You Need an Interactive Website Archive | Hanzo



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

The Food and Drug Administration (FDA) regulates ads for prescription drugs, but it usually only works reactively, once the ads have been created and served. For pharmaceutical companies, this creates a dilemma: As they strive to create ads that they believe comply with regulations, they must also be prepared to provide those ads to the FDA – and remove them from circulation. – if they are called into question.

Most biotech and pharmaceutical companies are aware that they must archive their websites to meet FDA requirements, but they may not realize that an old archive won’t do.

Let’s take a closer look at FDA’s advertising regulations, what is included in online pharmaceutical advertising, and why businesses need interactive website archives.

FDA Online Advertising Regulations

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

There is one small problem, however, that the FDA’s advertising regulations do not directly affect the Internet. Most advertising advice predates general internet usage, so it doesn’t exactly tell businesses how to respond to social media comments or take advantage of the interactive nature of the internet. The FDA has tried to fill some of these gaps by creating draft guidance documents, but these are incomplete solutions and by no means have been adopted as final.

However, the prescription drug advertising rules that apply to television or radio ads also apply to banner ads, online video ads, and product web pages. Under these rules, advertisements must:

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

Because companies can’t emphasize a drug’s benefits or downplay its risks, the layout and presentation of advertisements is important. Headings, font size, bullets, and the amount of white space around the text are all important when determining whether the ad meets the FDA’s fair balance requirement.

Online drug advertisements must 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 advertisements 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 all the risks of their medications and devices, and
  • promote their drugs and devices.

Anything you see online about a prescription drug or device, from the dedicated product website or information page to banner ads, online video ads, media pages or ads social and search engine results promoted, equates to online advertising that must meet strict FDA requirements. advertising requirements.

In most cases, however, the FDA notes that “Pharmaceutical companies should 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. that we can prevent the advertisement from appearing or request corrections to the advertisement. When the FDA hears complaints about an ad, it can issue a letter of violation, requiring the company to respond and / or suspend the ad.

This is where internet archives become important, but static archives like screenshots leave a lot to be desired.

Why Businesses Need an Interactive Website Archive

Suppose the FDA contacts your business about an advertisement or product page that is currently live on your website. At this point, it is quite easy to refute or explain the alleged violation. You can go to the site live, demonstrate how it works, and show how you presented the necessary warnings, evidence, and a balanced view of the risks and benefits of the drug or device.

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

Screenshots and other static archiving methods only present a moment in time and sometimes that moment is not a reasonable representation of all advertising. This is especially true with video content and interactive content such as text hovered over or over the mouse. Your ad may include all necessary disclaimers and risk statements, but they are only visible when a customer interacts with the ad itself.

That’s why businesses need to have functional and 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, however, a picture is worth a thousand words. So, in our next blog in this series, we’ll go over a recent example of an FDA violation letter, including the attached screenshots “depicting” the ad, to show how the screenshots fail.

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