Evan Gumz, Hanzo: FDA Regulatory Compliance: Can You Prove What Your Website Said?

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Extract from Evan Gumz’s article “FDA Regulatory Compliance: Can You Prove What Your Website Said?”

If you’re marketing any pharmaceutical or medical device, the Food and Drug Administration (FDA) has its eye on you. More accurately, the FDA has its eye on your website and social media, checking to see what you’re claiming about the efficacy of your product and evaluating whether your claims are backed up with adequate evidence.

Should a regulatory agency challenge something currently on your website, it’s at least reasonably easy to prove or disprove that allegation. You can go to the live site, explain how it functions, and demonstrate where you have disclaimers and evidentiary support. 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? Will you be able to point to functional, interactive website archives to prove that your former content was, in fact, in compliance with regulations?

Here’s what you’re up against.

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