I got a heads up from a good fellow on Twitter this week that the FDA had begun a new twitter feed from MedWatch called, of course, @FDAMedWatch. MedWatch is a service set up by the FDA to alert the public to safety information about products over which it has jurisdiction, including drugs, devices and biologics, about safety issues or adverse events. This makes a total of 8 twitter feeds from the FDA, all of which are contained on the Eye on FDA listing of FDA feeds.
That is a smart move on the part of FDA, and probably late in coming. Having a twitter feed is one of the fastest ways to spread news – it is free, it is easy and it is highly targeted to reach people who care about what you have to say . You not only reach your friends, but your friends' friends. It is what I call the Twitter Echo Chamber.
Back in March 2009, when I interviewed the FDA via a podcast about their position on regulating social media, it was the first time the agency had said anything about the topic. At the time I only had about 750 twitter followers (today, thanks to my 3678 followers!). I sent out a tweet that let people know about the podcast and asked my followers to re- tweet the message. If my memory serves me correctly, about 46 of them did within a few hours. I actually went and tallied the number of followers that each of them had and added them up. It numbered nearly 10,000 people. These, of course, weren't any people, they were mostly people probably pre-disposed to being interested in the information, because they were following people who were following me. That is the beauty of social media. You don't have to advertise to the 5,000,000 to get to the 10,000 who you need to hear your message, you just get directly to the people who matter to you. Today, the second generation of followers of my followers numbers extraordinarily high, as probably do your's.
For that reason, a number of pharma companies have also started Twitter feeds, as documented by Jonathan Richman's social media and pharma Wiki at Dose of Digital. In fact, a lot of pharma companies have embraced Twitter on multiple levels, including for the recruitment of new staff. And it stands to reason that a number of people who follow them on Twitter are people who use their products.
Let's make up a hypothetical here. Let's say drug XYZ made by MonCom (Monster Company) is approved by FDA for the treatment of a cardiovascular ailment, but also has an indication for treatment of Type 2 diabetes. Let's also say MonCom is on Twitter and their feed is followed by both heart groups and patients, and Type 2 diabetics and their patient organizations.
What would happen if FDA's MedWatch twitter feed issued an adverse event report that was particular to one indication for drug XYZ – the one for Type 2 diabetics. So something like "Adverse event associated with XYZ drug for Type 2 diabetics". Could MonCom re-tweet the FDA's MedWatch Tweet?
Hmmm. What would MonCom's Regulatory folks say about that? The company would be re-tweeting a tweet that carries the name of the drug and the indication without the additional information about risk. Would a company risk a Notice of Violation letter by re-tweeting the FDA tweet about an adverse event associated with their own medical product? They would be performing a public health service but possibly incurring a technical violation. And DDMAC is all about the technical violation. Yet if they don't re-tweet the FDA MedWatch tweet, then it is possible that a number of their Type 2 diabetic patients might not see the adverse event report.
To tweet or not to tweet? I leave it up to you. But it is just one more indication of the type of predicament that is created when the agency that regulates communications in a rapidly changing environment does not keep up with the times. And speaking of keeping up, isn't it almost past time for the first installment of the guidance from FDA on the regulation of the Internet and social media? DDMAC has long promised it this year, though has also said that it could not be guaranteed. We are waiting to see if MonCom should hit the SEND button and send out the FDA MedWatch alert….
Great question. Personally, I would frame the FDA incident report in a press release or blog post and then post a link to this official company response on Twitter.
Pharma is looking for the FDA to issue guidance so the industry can absolve itself of responsibility for what is little more than applied common sense. Social media is a 2-way communication, and pharma does not want a 2-way conversation, they want to talk AT patients, not WITH them. It can be done, but it involves creating a dialogue , not a passive advertising channel like television.