Talking the Walk in Social Media Regulation
11/04/09 21:36 Filed in: Social Media Regulation
You gotta think you're pretty smart if you expect people to read your blog about drug regulation. You gotta think you're really really smart if you expect people to read your blog posts about FDA's regulation of the internet and social media. You also can't take yourself so seriously. It gets pretty tedious and dense and it can get pretty surreal. I've been reading a lot of conjecture from blog to blog and tweet to tweet about the regulatory issues with FDA's Public meeting next week as well, and I'm amazed at the many people engaged with genuine interest in regulatory dialogue. I'm not agreeing with everything that I read or hear. It's easy for me to get defensive or offended when I read or hear one blogger or marketing consultant after another opine on regulatory issues that I've spent nearly my entire adult life navigating. I imagine though, that it's a lot like the way doctors must feel when they see everyone and their mother spewing medical opinions and perspectives all over the internet. What right do ordinary citizens have to converse about medicine and health care?
And then I realize that to feel that way is just stupid. There isn't a more elegant or intellectual term for it.
Why wouldn't people be hyper-concerned about medical issues and actually converse about it the way they converse about it today--web 2.0 style? Isn't that precisely the power and value of medical communication on the web and in social media? And then it occurs to me that this makes all the sense in the world that drug marketers and their business partners and agencies ought to be similarly hyper-concerned about regulatory issues that affect them directly. FDA's "guidance" will set policy for everyone in an extraordinarily profound way. It's nearly impossible to overstate how profound it will be to everyone involved. Even if FDA comes out next year and says "Status Quo everybody, just keep not doing what you're not doing" that is going to have profound impact on medical communication.
As another example, just think about the revolution in healthcare communication that FDA's DTC broadcast advertising guidance led to. That guidance document, drafted in 1997 and finalized in 1999 dealt with one single thing--how to provide the labeling to people who watch a TV ad for a prescription drug (by telephone, website, or concurrent running print ad). That's it. A decade later, DTC advertising is tied to the whipping post of every regulatory, Medicare, and healthcare reform discussions. Lots of money is spent on DTC advertising. Lots. And lots, lots more money is spent on drugs as a result of DTC advertising. If nothing else, people are more aware and engaged in their own medical care today as a result. All this because FDA said you can run a TV ad if you provided access to drug labeling or a brief summary by giving someone a phone number to request it by phone, a website address to get it throught the internet, and the name of a magazine so someone could go read a brief summary in a concurrently running print advertisement. That small revolution is a stepping stone (or boulder) upon which today's medical communications are built.
On the other hand, FDA's upcoming public meeting is asking a bread basket of questions about a lot of different issues. Lord knows where any potential guidance or guidances (plural) will go, but chances are, it will address more than one issue. The influence of any FDA guidance will be extensive, to understate things. So if you're interested in regulatory issues and blogging and conversing and opining, keep it up. If you're speaking at FDA's public meeting next week, represent your industry well--with honesty, principles, concern and reverence for the importance of what you do-and what FDA does and how it all impacts patients and doctors.
Just as every human is the most important player in their own medical care, every medical communicator is the most important player in FDA's regulation of medical communication. As a compliance professional and a regulator, I always have the perspective, that when I give people advice and direction, that advice is more important to my client than it is to me. I'm not engaging in the regulated activity, they are. I make submissions to FDA and I go back to my computer and my telephone and my pile of paper. They go out and actually engage in the communication that FDA is watching and regulating. It's refreshing to see the professional engagement of diverse groups of business people in FDA's meeting on the internet and social media next week.
Next week and forever afterward, keep it professional and principled and reverent to that sacred place where medical decisions are made--where real people make real decisions to use medicine in the hope that it helps and doesn't harm. Avoid cliches and talk the walk and walk the talk. It's a new world, and FDA's regulation of the internet and social media is about what happens when we are talking and how that affects how others talk and then walk.
See you in DC.
Regards,
John Murray
And then I realize that to feel that way is just stupid. There isn't a more elegant or intellectual term for it.
Why wouldn't people be hyper-concerned about medical issues and actually converse about it the way they converse about it today--web 2.0 style? Isn't that precisely the power and value of medical communication on the web and in social media? And then it occurs to me that this makes all the sense in the world that drug marketers and their business partners and agencies ought to be similarly hyper-concerned about regulatory issues that affect them directly. FDA's "guidance" will set policy for everyone in an extraordinarily profound way. It's nearly impossible to overstate how profound it will be to everyone involved. Even if FDA comes out next year and says "Status Quo everybody, just keep not doing what you're not doing" that is going to have profound impact on medical communication.
As another example, just think about the revolution in healthcare communication that FDA's DTC broadcast advertising guidance led to. That guidance document, drafted in 1997 and finalized in 1999 dealt with one single thing--how to provide the labeling to people who watch a TV ad for a prescription drug (by telephone, website, or concurrent running print ad). That's it. A decade later, DTC advertising is tied to the whipping post of every regulatory, Medicare, and healthcare reform discussions. Lots of money is spent on DTC advertising. Lots. And lots, lots more money is spent on drugs as a result of DTC advertising. If nothing else, people are more aware and engaged in their own medical care today as a result. All this because FDA said you can run a TV ad if you provided access to drug labeling or a brief summary by giving someone a phone number to request it by phone, a website address to get it throught the internet, and the name of a magazine so someone could go read a brief summary in a concurrently running print advertisement. That small revolution is a stepping stone (or boulder) upon which today's medical communications are built.
On the other hand, FDA's upcoming public meeting is asking a bread basket of questions about a lot of different issues. Lord knows where any potential guidance or guidances (plural) will go, but chances are, it will address more than one issue. The influence of any FDA guidance will be extensive, to understate things. So if you're interested in regulatory issues and blogging and conversing and opining, keep it up. If you're speaking at FDA's public meeting next week, represent your industry well--with honesty, principles, concern and reverence for the importance of what you do-and what FDA does and how it all impacts patients and doctors.
Just as every human is the most important player in their own medical care, every medical communicator is the most important player in FDA's regulation of medical communication. As a compliance professional and a regulator, I always have the perspective, that when I give people advice and direction, that advice is more important to my client than it is to me. I'm not engaging in the regulated activity, they are. I make submissions to FDA and I go back to my computer and my telephone and my pile of paper. They go out and actually engage in the communication that FDA is watching and regulating. It's refreshing to see the professional engagement of diverse groups of business people in FDA's meeting on the internet and social media next week.
Next week and forever afterward, keep it professional and principled and reverent to that sacred place where medical decisions are made--where real people make real decisions to use medicine in the hope that it helps and doesn't harm. Avoid cliches and talk the walk and walk the talk. It's a new world, and FDA's regulation of the internet and social media is about what happens when we are talking and how that affects how others talk and then walk.
See you in DC.
Regards,
John Murray