In response to a special request, this post provides some general guidelines on communicating about FDA-regulated products. However, let me start by emphasizing that I am not a regulatory expert. I have a lot of experience with FDA-regulated products, and I’m offering this from a communications perspective. So here are my product communications Do’s and Don’ts:
1. Work closely with regulatory counsel. I’ve always valued a close and collaborative relationship with the folks in regulatory and I try to involve them in the planning process as well as the document review process. Sitting across the table from them helps because when I understand why they say “No, you can’t do or say that,” I brainstorm with them to get to the “Yes, you can do or say that.” I’ve also learned that, just like with doctors, lawyers and even marketing communications people, recommendations vary from expert to expert and client to client. Often regulatory guidance comes down to a judgment call on the level of risk the client is or is not willing to bear.
2. Include risk information in appropriate materials. The challenge surrounds what the appropriate materials are. Some are straightforward, such as advertisements and collateral and of course these must include fair balance. I won’t tread into social media and the guidance (or lack thereof) as it’s a subject that’s been beaten to death. But how about press materials?
- Press Releases: One client’s regulatory counsel has advised that press releases remain one exception, and we still don’t include fair balance in our releases for that client. A colleague who works for a large agency shared the opposite – that they include fair balance in all press releases they develop for pharma and med device clients.
- Pitch letters: This short, simple medium was never intended for the public. Pitch letters are one-on-one communication directed at the media from a company or agency to interest them in your latest news and information. But a pitch letter recently received a red flag from the FDA, and now we’re all waiting with bated breath to see if we need to start including risk information in them. Guess what? So far it depends on which regulatory person you ask! (Read more about it here: http://www.prweekus.com/pharma-communicators-keep-eye-on-fda-after-it-singles-out-product-pitch/article/270458/)
3. Present risk information in a balanced way. Including the fair balance information at the end isn’t enough. You need to be sure that you (or your spokespeople, such as patients) tell your story in a evenhanded way.
- Don’t let your spokespeople minimize the risk information. (One celebrity spokesperson declared during a national TV interview: “Oh, drug companies just have to say that…” The drug company and agency had to work with the outlet to have it corrected immediately.)
- Testimonials can’t overstate the product’s benefits. (For example, “Because of this product I improved my golf game” needs to be something more along the lines of: “Because I use this product, I feel better and because I feel better, I play golf better.”)
4. Ensure adverse event reporting processes are in place. As you all know, adverse event reporting has been a big reason some pharma or device companies have stayed away from product-oriented social media initiatives. One client worked with her regulatory team to develop a weekly reporting process, and also relies on frequent check-ins with regulatory both at her business unit and at the corporate level. As we’re all learning, it can be done.
5. Understand the difference between the FDA and SEC. Regulations from each guide your communications recommendations for publicly traded companies and their products. It’s important to understand whether your information is material and the level of flexibility you have in what to convey, timing your announcements or launches, etc.
1. Don’t provide information on off-label uses. Controlling off-label statements presents a challenge in two-way social media channels, but now we have FDA draft guidance on this issue. You can find a great at-a-glance diagram of this guidance here: http://www.doseofdigital.com/2012/01/translating-fda-social-media-guidance/.
2. Don’t overstate claims or claim superiority if you don’t have data to support it.
3. Don’t give medical advice. Instead we include a call-to-action that directs potential patients to speak to their doctors.
This is my general guide on communicating about FDA-regulated products. But please keep in mind:
This information reflects my experience in working with FDA-regulated products and teams on the client side. It is based on a snapshot in time because policies at the FDA can (and do) change. Please only use this is a guide, and if you need the final word on matters, talk to your regulatory expert!
Now let’s hear about your experience!