As someone deeply immersed in pharma communications, and especially the newer realm of social networking, I’ve been closely following the ongoing process of the industry/FDA dance, trying to figure out how social media/web 2.0 approaches “fit” with pharmaceutical manufacturers and their various audiences.
And I keep wondering if we’re going about the whole thing the wrong way.
Think about the fine print PI (Product Information) you see in a magazine, accompanying a prescription drug ad. How many people do you think really READ that? And, of that miniscule number, how many actually UNDERSTAND it?
This is not “communication.” It is “exposure of comprehensive required information.”
Now stop and think. If the joint goal of patients, doctors, regulators, and manufacturers is the right treatment given to the right patient at the right time for the right reason (shouldn’t that be the ultimate goal for all involved?), then what we need is more than mere CYA disclosure. We need communication, designed properly for each audience, and digestible in ways that reflect how we (in fact) genuinely communicate.
I’m in the process of selling and buying a house. And, roughly, there’s a 3-fold communication/thought process:
- 1. Basic, initial go-or-no-go information that helps me figure out whether something might be for me (e.g., a 2-bedroom split-level with a flooding basement on a 0.2 acre lot near a highway is not of interest).
- 2. A deeper layer of information that will let me whittle down further what matters, based on key points (e.g., a house visit with the realtor to really explore the place after all basic stuff has narrowed things down).
- 3. All the inspection and contractual details that must be waded through (comprehensive disclosure) once we have a pretty good idea of direction (e.g., call the lawyers and examine the paperwork).
We don’t start with #3. But much of what passes for pharma communications is so hog-tied by regulatory pressure on the comprehensive disclosure front, that the cart is effectively placed before the horse – if the horse is even allowed to show up. Effective communication is severely hampered.
If we’ve done full disclosure, such that the FDA isn’t dropping big fines, yet we’re really not communicating effectively with about the right treatment for the right patient at the right time for the right reason, then I have to conclude that we’ve all failed. And that’s what I fear will happen with the proposed FDA guidance on social media in pharma – we’ll all be so tied up with the disclosure minefield that no one is paying attention to the real point – what does it mean to effectively communicate on every level about prescription drugs and health?
There are basic principles of instructional design and “layered” multi-channel communication that seem to me far more vital than an endless “cover your backside” fear-based pursuit of comprehensive disclosure. I’d far rather see time and creativity invested in designing a prescription drug product information portal with layers of information (digestible for all audiences), multimedia education, and controlled interactivity than figuring out how we’re going to stuff a full PI into a coffee mug, a magazine insert, a TV ad, or a tweet. Can’t we take advantage of all this linked and multi-channel approaches to communicate more effectively and completely, rather than less so?
Social media provides wonderful new ways to establish information-sharing and build bridges with stakeholders across the entire healthcare chain, from drug manufacturers all the way through to patients. But if we look at it through all the old lenses, I suspect we’ll end up with the same old communication constipation that we have now. That would be a shame.
End of rant. Your ideas and feedback welcome in the comments.
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Good rant and great points about the fact that no one goes near the PI information. The industry needs to live in a hypertexted world where the very nature of communications is turned upside down and enables deeper engagement.
[…] But Are We Communicating? My rant on pharma communications, regulations, and social media. […]
Steve, thanks for the insightful post. I couldn’t agree more. There seems to be this belief that passing guidance on social media will somehow cure all ills that plague the pharmaceutical industry. In reality, there are larger issues at hand than merely passing guidance. In other words: when the FDA does offer some insights; it likely won’t lead to a flood of companies rushing to get involved in social media. There are more challenges to overcome. As you point out, there is a fundamental flaw in the manner in which we are currently communicating. I am reminded of something my mother always used to say to me when I was young: “Yea, you heard me but are you listening?” The same holds true here: “We are talking but are we communicating?”
Be careful regarding “hypertexted PI” because this issue was addressed at the FIRST FDA public hearing back in 1996. You’ll have to dig up the transcript. The issue was that linking to different parts of the PI can be manipulated so that only the good parts get seen or perhaps people won’t click on the links to the bad parts. The other issue discussed was unauthorized copying and republishing edited versions. That’s primarily why most PIs are presented in uneditable PDF files.
There are simplified “patient information” versions that the FDA has approved. Pfizer has been in the forefront of using this technique.
Back in February 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers (see “FDA Draft Guidance for Print DTCA: Less than Feared”).
The draft guidance “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements” encourages manufacturers to use clearer, less cluttered formats for presenting risk information and encourages them to focus their risk disclosures on the most important and the most common risks and to do so in language easily understood by the average consumer.
Find the links to the above here: http://bit.ly/9tIhRD
John, all of the above is valid. My major point, however, is that complete and comprehensive disclosure can be preserved – but in the context of far more approachable information design (especially on-line). If our starting point is CYA full disclosure text format, and you whittle from there – well, you end up with slightly less ineffective CYA approaches. The starting point should be best ways to communicate at the level of patient/physician/caregiver need.
Unfortunately, as I said in my post a few years ago, the lawyers are writing these things, not information specialists. You’ll also find that the lawyers are the ones who are primarily drafting the comments that drug companies have submitted to the FDA regarding regulation of social media in general.
From that I conclude that most pharma companies are still more concerned with the legal issues rather than the communication issues! It’s hard to blame them when you got whistleblower suits and patient class action suits popping up everywhere. You’ll see this problem pop up in my April 6 discussion with Dennis Urbaniak.
I have to agree wholeheartedly- no one is reading it, and if they do- who really understands it? I think you mention several options for the remedy to the situation, such as interactive education modules- but what about just adding pictures? Granted, they could be potentially scary, but as long as they are just mentioning what the text does or would have- it is the same. I don’t think they could replace PI, but they might make it more simple to navigate- easier to read, and certainly easier to comprehend. It would have to be looked at more closely- from a regulatory standpoint- but I think it could work.
Amber,
How about a color-coded schema as described in this post: “FDA Considers Color Code for Food Labels, But Not for Drug Labels” http://bit.ly/dxJjjz