Friday, March 27, 2009

DoseofDigital: "Is the FDA Already Creating Digital Promotion Rules?"

source: Dose of Digital blog (Jonathan Richman)

link to original:

[below is simply a re-post of Jonathan's great, thought-provoking blog)

Many people in and around the pharma industry have been asking for the FDA to create some more specific and updated guidelines for digital promotion. There have been a bunch of conferences where it’s been a hot topic and I’m sure there’s been a few focus groups, but one thing’s been lacking from these. The FDA. They’ve been pretty quiet. 

As it stands now, the FDA (actually DDMAC) regulatory guidance has been pretty thin regarding digital. I noted in a post a while back that the FDA recognizes 40 different types of promotion ranging from DTC TV to the archaic and oddly named “Professional House Organ.” All digital promotion is relegated to just one code “WWW” for  ”Internet Promotion.” There are about five different category types of print advertising for professionals, but there’s only one for everything possible in digital. I wonder where mobile fits in? Get your own 2253 submission form here and see for yourself.

So, I think we can all agree that the guidelines and oversight of digital promotion by the FDA are pretty weak. That doesn’t mean that they ignore digital promotion, as the folks from Shire found out when a YouTube video of theirs drew a warning letter. But, they haven’t spelled out what’s legal and what’s not, so everyone is left guessing just a bit. It appeared that Eye on FDA might have cracked this mystery a bit last week with their interview of an FDA official regarding the use of social media by pharma. Unfortunately, despite Eye on FDA’s best efforts, the FDA official was, not surprisingly, pretty vague and non-committal. The net was that there’s nothing inherently violative about social media, it’s the message that matters. In other words, just because your brand has a social media site doesn’t mean it’s in violation, but if the information and content on that social media platform  (e.g., off label, lacking fair balance) is in violation, then the entire thing is. No big surprise, as Shire can tell you. 

Today, MediaPost decided to get some attention by simply rehashing the Eye on FDA interview, but adding a more attention grabbing headline “FDA Official Tells Blogger That Pharma Social Media OK.” Technically, this was said, but it certainly wasn’t a green light for pharma companies to do whatever they want in social media. The MediaPost article has been all the rage on Twitter today, but I’m doubting many read the full details. This interview (and certainly MediaPost’s reworking) was far from providing any specific information on how pharma can use social media. MediaPost’s on my “list” today.

Okay, so no guidelines yet. How far are we from them? Great news! Not far. It appears that there’s already a workstream in place at FDA to develop new digital promotion guidelines. While poking around their site, I came across a section called “Policy Development and Guidance to Industry.” There’s a list of areas where FDA is developing new guidance. One of these is this:

Promotion on the Internet.- As part of an FDA working group, DDMAC is developing an agency-wide policy to address how advertising and promotion of FDA-regulated products will be regulated on the Internet.”

Outstanding. Relax everyone, the FDA has it well in hand. Sure, we’d like a say in what they come up with, but aren’t some guidelines better than none? I can stop my open letter to the FDA and all the discussions with colleagues on what we’d like to see in the guidelines. It’s too late. They’re coming.

Or are they?

Being a bit of an FDA skeptic, I dug a little further. I noticed that there wasn’t a date on the page, so I couldn’t immediately tell when it was updated. Never fear. Enter the Internet Archive Wayback Machine. For those not familiar with this outstanding tool. You can enter any domain name and this archive will show you updates to the domain and allow you to view the page as it looked in the past. I did a search for this FDA policy page and here’s what I got back. 

Pic link:

As you can see, some version of this page dates back to 2000. So, I clicked the link to the earliest version of this policy page, which dates back to November 20, 2000. The results unfortunately weren’t surprising. There it was…the same exact statement for “Promotion on the Internet.”

Promotion on the Internet- As part of an FDA working group, DDMAC is developing an agency-wide policy to address how advertising and promotion of FDA-regulated products will be regulated on the Internet.”

My hopes were dashed. 

Here’s what this tells me. The FDA’s been planning to deliver new guidelines for “Internet Promotion” for at least eight and a half years. Once more…eight and a half years. Take away message: Don’t hold your breath on new guidelines. 

Message two: Don’t stop doing new things in “Internet Promotion” because of this. Remember, as far as FDA is concerned, digital is a promotional channel like any other. The same rules apply to digital as they do to print and anything else. If you make claims, they’d better be on label and they’d better include fair balance. If you remember that one rule, you’ll stay out of trouble 95% of the time. 

We do still need to sort out some specifics around the use of social media. Is there ever a way that a brand could really open up live comments and discussion from patients on a branded site? Maybe. We lack the guidance about how this can be done successfully and in compliance though. However, the FDA is generally a fair bunch of folks. They don’t want to kill every idea of yours. They do want it to follow some rules and they will work with you to figure out a way you can do your idea and stay in compliance with the rules.  In other words, can I do this if I also agree to do that? For example, Fabio Gratton from Ignite Health came up with an idea that basically was a widget pharma companies could install on their social media sites that allowed patients to report adverse events in a single click. Perhaps if a company agreed to include this widget in a prominent, then FDA would allow live, unmoderated comments. Give a little, get a little.

For now, we don’t know, but that doesn’t mean we can’t forge ahead. The FDA will give comments on any idea before you launch it, so there’s no excuse to not try because you’re worried about trouble later. Get FDA involved early and you might be pleasantly surprised what’s possible. You won’t be the first try social media in pharma. Remember the Pharma and Healthcare Social Media Wiki we (including all of you) created? Well, share that with your company and show them that you wouldn’t be the first. Many others have tried and not one of these programs have gotten a single warning letter.

Why would you?

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