FDA Regulatory Compliance: Can You Prove What Your Website Said? | Hanzo


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If you market a pharmaceutical or medical device, the Food and Drug Administration (FDA) has an eye on you. Specifically, the FDA monitors your website and social media, checking what you claim about the effectiveness of your product and assessing whether your claims are supported by adequate evidence.

If a regulator disputes something currently on your website, it’s at least reasonably easy to prove or disprove that claim. You can go to the site live, explain how it works, and show where you have warnings and evidence. But what if you’ve changed your site and you no longer have the disputed content, or no longer have it in that format? Will you be able to point to a functional and interactive website archive to prove that your old content was in compliance with the regulations?

Here is what you are up against.

FDA Actively Investigates Websites and Social Media Accounts

The onset of the COVID-19 pandemic has sparked a flood of false claims involving supposed treatments, cures and preventatives. Even now, the FDA continues to monitor both social media and corporate websites for advertisements of products that claim to prevent or resolve COVID-19. Of 166 warning letters issued and published by the FDA in the first quarter of 2021, 28 of those letters concerned suspected COVID-19 treatments. Given the spread of disinformation about the virus, the agency also encourages citizens to directly report any unauthorized treatment they see advertised and is listing businesses she warned about on a fraudulent COVID-19 product website.

To take just one example from the start of the year – and a particularly colorful example –the FDA recently warned Everything Health LLC that his “CoronaBox” was an unapproved and mislabelled product that purported to prevent and treat COVID-19. In that letter, the FDA said it had reviewed the company’s website as well as its Facebook, Instagram, Twitter and YouTube accounts, which “direct all consumers to your website … to buy your products.” Among the claims that the FDA opposed were the statements “The Corona box is all you need to expel this nasty virus!” “And” I reverse the crown using GODS [SIC] DOCTOR’S OFFICE.”

While this example is a blatant misrepresentation of a product’s effectiveness, it’s not hard to see how the door is opened for individuals to complain about advertisements and how businesses can struggle to prove that their online content complies with FDA regulations.

Regulatory compliance is as good as proof of compliance

We often say that an organization’s compliance with regulations is as good as its ability to prove compliance. Here’s how it might play out right now.

With the FDA encouraging people to report concerns directly, a competitor or disgruntled former employee could easily take a screenshot of your website or social media and distort your content in one of two ways. First, let’s say you provide all the disclaimers and evidence required for your claims, but do so in an interactive text element. Maybe you need to scroll down for a pop-up to appear, or maybe you have some essential language in the hovered text. No matter how you access this content, it’s definitely there, it’s clear and your customers can’t miss it, but a carefully chosen screenshot could do it. Alternatively, suppose we assume a more nefarious actor. In this case, anyone could edit a screenshot or still image to make it appear as if you haven’t included any warnings about your products or evidence of your claims, even though you have it. clearly done.

If you don’t have an interactive, fully functional archive of your website, how will you be able to prove – a month or two or six later, when the FDA contacts you – that the required language was there?

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