About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Fact or Fiction – FDA Has a Policy on Social Media?
Today the Post ran a story in its Health Section that had the headline "Drug Firms Jockey for Space Online" and when the story print continuity breaks and carries on to a subsequent page, the headline is "Drugmakers Seeking a Niche Flock to Online Social Media." Emphasis my own.
Flock? Flock? FLOCK? The only way you could use the term "flock" in connection with pharmaceutical firms and social media is to say that companies are a scared flock of geese. And they are frightened because they are regulated by an agency at FDA – DDMAC – which has a fundamental lack of understanding of how people use the Internet for healthcare and therefore does not understand how to regulate it. The result has been regulatory action taken against companies where the rules are unclear and what seems clear one minute is completely unclear in the next.
How many minutes in a video or Webcast before you have to mention the risk information associated with a drug? If you mention a benefit, how much time do you have to mention the risk? Know the answer? No, no one does. Apparently DDMAC knew, but didn't tell anyone and the fact that no one knew of such a policy didn't stop DDMAC from issuing a warning letter to a Johnson & Johnson this month for violating that unknown rule. According to the Warning Letter, the video was six minutes long with the risk information bundled at the seventh minute. Would you have guessed that to be ok? On a print ad, the risk information is at the end of a multi-page ad (and no one reads it). What would the difference be? No one knows, and DDMAC apparently makes this stuff up as they go along. That is the kind of Whack-a-Mole game DDMAC plays. We won't tell you what is off limits, until you do it and then WHACK!
Can a company respond to a request for information in a chat room? When do companies have to report potential adverse events seen perceived in social media? If a company makes a comment or entry on another Web site and leaves their own Web site information (as everyone does) have they tripped a regulatory wire? How long into a YouTube video before a company has to mention risk? Is it a minute, is it two – it certainly isn't six we have learned.
Does risk information need to be included in a search engine ad that names the drug and what it is for when the placement of the risk information is no differently handled than in a print ad? Years went by before DDMAC answered that one and apparently the answer was yes. This, despite the fact that anyone who understands how the Internet is used would know that if a patient is interested in the drug mention, they will click on the link and land on the page with the risk information on it.
So many unanswered questions about the innumerable nuances of social media and the Internet, and an agency that keeps mum about the rules. What is dysfunctional in that?
That is what was so shocking about the Post article was that its headlines imply this stampede to social media to promote drugs. In fact, compared to other industries not hobbled by an ineffective regulatory body, the offerings made by pharma in the social media space have been nothing short of anemic, uncoordinated and lacking in sophistication. And the number of companies actually doing anything at all out of the number of companies that actually exist is miniscule. Anyone looking at the comprehensive forest would see that there are very few trees within it.
And that was what was so amazing about the statement from the FDA in this article. Here it is:
"If drug companies or others working on behalf of drug companies wish to promote [their products] using social media tools, FDFA would evaluate the resulting messages as to whether they comply with the applicable laws and regulations. our laws and regulations don't restrict thte channels that prescription drug companies choose to use for disseminating product promotional messages."
That is the same line they fed me during my podcast with DDMAC in March which turned out to be inaccurate when they issued the 14 untitled letters on search engine ads. They are still sticking to their story – but take a whole dose of caveat emptor if you want to rely on it.