You’ve got to deal with two groups...your internal legal and reg team and the FDA
The regulatory folks at your company aren’t standing in the way of your program because they don’t like you (probably not anyway). They aren’t saying “no” because it’s much simpler to do so. They have good reasons. Likely, they understand both the internal and external rules much better than you do. As you’re developing your program, invest some time in understanding the regulatory rules that are likely to have an impact on your program. If you do this well, then the approval process should be much simpler and it’s going to allow you to be a better partner, as you’ll be able to really understand where your regulatory colleagues’ concerns.
Be honest. You know the flaws in the program you’re creating. You know why it will never get approved as is. Why bash your head against the wall then? Be tough on your program just as you know your regulatory team will be. Doing this during the development process is going to force you to rethink things and to look for ways to do them differently. This might be where the big breakthrough comes from. A word of caution: don’t completely stifle an idea because you think it’ll never get approved. That’s an innovation killer. Figure out a different approach that might work or…
You probably have a very formal process for reviewing a new program. That’s good. But sometimes, you need to go outside this process a bit. As you’re developing your program and run into something that you think is going to give your regulatory team (and therefore federal regulators) heartburn, ask. Ask someone on your regulatory team for advice. You can do this rather informally and it may save you a ton of heartbreak and money later on. It makes no sense to completely develop a program (including all the resources you’ll use) only to find out that the key component is a complete non-starter. Check in before you commit too much to see where the problems might lie. You can not only do this internally, but also externally as well. You can request a meeting with DDMAC (the pharma marketing arm of FDA), for example, to review an idea before it’s complete. They will give you their take on why or why not your program is all right. This is a formal process that your regulatory team can help you set up. If you’re thinking about a really big, really innovative program, don’t get a million dollars into it before you figure out that DDMAC will never allow it. Take advantage of these meetings. Your fees and tax dollars are paying for them anyway.
You may be a social media expert. Great. Chances are that the people who have to approve your program aren’t. That’s a problem. While you’ve invested a lot of time figuring out how to, say, do a brand page on Facebook that will be compliant, your regulatory teams might not understand the finer points of Facebook. Because of this, they only can go on what they’ve heard or read. We all know that’s not enough. You never really understand the finer points of a channel until you dig in yourself. That’s part of your job. While you can argue that it’s also part of your regulatory team’s job too, it might not be happening that way. That’s where you come in. Educate your team. Teach them about emerging channels and the benefits and risks of each ahead of time. Don’t try to teach them about Twitter in the meeting where you’re asking for approval to do a branded Twitter page. It’s a little late then. (My company, Bridge Worldwide, via WPP, offers a “Digital Immersion” program that can do this sort of training as a one-day seminar. Contact me if you’re interested in hearing more.)
This one isn’t mine, but I had to use it because it says it all so perfectly. It comes from Marc Monseau, Director, Media Relations at Johnson & Johnson. You may have heard his name from the J&J blog he helps edit or the J&J Twitter account that he manages. Both, in my opinion, are the standard in healthcare. Marc sent this tweet a couple weeks ago in connection with the Business Development Institute (#BDI) conference I mentioned earlier:Think about that for a minute. Which do you hear when you propose something to your regulatory group? The first one, “Yes, if…”, indicates someone who’s willing to help you find a way to make your idea possible. You might not like the concession, but it’s a step forward. The latter, “No, because…”, tells me that this regulatory person isn’t interested in a solution, but rather just in following the company’s and federal regulatory rules. It doesn’t have to be that way though. Force your regulatory teams to think about the issue with “Yes, if…” instead of “No, because…” It’s a powerful difference. You can enable this by talking this way yourself during the discussions with your regulatory team. Come prepared with alternatives and be willing to compromise (assuming it doesn’t kill the intent of your program), but also encourage your colleagues to do the same. PS: you might want to add that this idea comes from J&J, who probably has the most robust social media program of any healthcare company.
This isn’t “Do something just for the sake of doing it.” Here, I want you to try something because I want you to test all of the above. If your company hasn’t delved into any major social media initiatives and you suddenly spring one on them, expect it to be denied pretty quickly. Instead, do something small now. Maybe an unbranded Facebook page. It doesn’t have to be incredibly robust and the point isn’t to get thousands of people to join. Your goal is to test your process. The process for approving a social media program might be completely different than any other program. Do you know the process? Is there a process? Maybe you need approval from a higher level or the PR/corporate communications team needs a say. The process may be totally different from everything else. Figure it out now, so that when your big program comes up for review, people will be familiar with the process and you won’t have to waste time figuring it out. Also, if you need to respond very quickly to something in the social media space, you can’t waste time creating a process, as things happen in hours, not weeks when it comes to social media.
6 Tips for Getting Your Pharma Social Media Idea Approved
6 Steps to Getting Your Healthcare Social Media Idea Approved<br />Jonathan Richman<br />Author, Dose of Digital<br />Director of Business Development, Bridge Worldwide<br />@jonmrich<br />
The steps to getting your idea approved<br />Know the “why”<br />Become your own toughest critic<br />Check in along the way<br />Be an educator first<br />Force “Yes, if…” instead of “No, because…”<br />Try something<br />
Know the “why”<br />Learn the basics of DDMAC<br />Know your internal rules<br />
Become your own toughest critic<br />Be tough on your idea<br />Anticipate what the issues will be<br />Don’t kill something because you’re afraid it won’t get approved<br />
Check in along the way<br />Ask before you go too far<br />Yes, you can ask the FDA BEFORE you launch something<br />
Be an educator first<br />You can’t be the only expert<br />Step one is to educate EVERYONE involved<br />
Force “Yes, if…” instead of “No, because…”<br />“No, because...” is an ending<br />“Yes, if...” is a beginning<br />Make this the team rule<br />
Try something<br />Not just for the sake of doing it<br />Test your process now before it’s too late<br />Try it out on something small<br />