FDA 2.0: Why Doesn’t “Beta” Work With the FDA?

Image by http://www.flickr.com/photos/fastjack/ / CC BY 2.0

By DJ Edgerton

Digital media functions on trial and error.

• Wikipedia was supposed to be a behind-the-scenes section of an online encyclopedia.
• SMS was supposed to be a way to check mobile networks.
• Twitter was designed as a way to use your mobile phone to send mass SMS messages.

Users take a new product or service and figure out what it’s really good for. (That’s not always the same as what the developers had in mind.)

But public beta doesn’t exactly fly with FDA thinking. This method of crowdsourcing, developing in public – it’s directly contradictory to FDA-approved activity. The FDA does not accept “we’ll start this way and it’ll develop organically from there”. The FDA wants rules. Strictures. The FDA wants to see what the public will see, before they see it; know precisely how it’ll be used, before it’s used; and give you approval based only on those guidelines, before it goes anywhere.

Digital media’s method of beta development and the FDA are mutually exclusive.

Or that’s how it seems at first. But when you think about it, don’t drugs develop in much the same way?

• Sildenafil (Viagra) was developed to treat high blood pressure.
• Arthritis drug rituximab was first approved for cancer.
• Topiramate was approved for epileptic seizures, but found use for migraine, bipolar disorder, obesity and alcoholism.

Maybe the FDA is used to evolution after all. But this comparison helps us even more than we realize at first.

Often, the best way to explain something is to compare it to something that’s already understood. The FDA is trying to come to grips with social media. Can we structure Pharma social media projects in ways that will make them seem more familiar and comfortable to the FDA – by making them more like what they’re already used to?

• Submitting FYI mock-ups of new projects – not necessarily for review and approval, but as a courtesy – before they launch – and understanding that when and if the FDA were to review and take issue with them, they’d be altered or pulled. Such a “gentlemen’s agreement” would make the FDA feel comfortable, and would probably ensure a higher level of scrutiny before going live.
• Sending “sNDA” style smaller versions of these submissions when projects have clearly morphed into a different animal – when just the chat section stays live, when user-submitted pictures become the main content driver, etc.

Can you think of another way we can help the FDA come to terms with social media by making our projects analogous to situations they’re familiar with?