This year I have written several pieces calling out FDA for their lack of enlightenment about Internet and social media marketing. My conclusion has been that literal application of last century regulations, without understanding the changes in media are counter-productive to FDA's stated mission.

I spared no scorn criticising the agency in posts titled like "FDA Bureaucrats Gone Wild, Launch a Witch Hunt on Internet Marketing", "Will DDMAC Ever Get a Clue About Internet Marketing?" and "Dumb Regulation Watch: Traditional Healthcare Marketing Rules Can Be Meaningless Online". I have been ahead of my colleagues in calling out FDA's flaws, but now looks like the frustration with the agency is growing louder and louder.

In the last weeks pharma blogs hosted some pointed exchanges

Mark Senak of EyeOnFDA, went on something of a rant (Fact or Fiction - FDA Has a Policy on Social Media?), decrying FDA's lack of clarity in regulating online and social media marketing. Mark's post debunks the myth of pharma companies jumping on social media bandwagon, highlighted in Washington Post, because they fear the regulator that does not know what it is doing:

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.

You can read Mark's piece for further examples, but I would like to highlight why his post is so significant. Pharma marketers who work closely with the industry are facing enormous risks. The regulator has the absolute authority over life and death of pharma products and companies. In this kind of environment you would not expect subjects of regulation to criticize publicly, unless things are coming to a head. The fact that Mark Senak, representative of a major agency, would speak up suggests that FDA must have really gone bonkers. He has every right to be angry:

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 minuscule. 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.

FDA's incompetence is hurting the American consumer

How so? The public deserves timely access to accurate information about available treatment options. They should be able to get it wherever they want it and however they want it. However, FDA's punitive and clueless attitudes are restricting availability of medication information via modern communication channels. Whether by malice or incompetence, the agency is creating the situation when everyone is talking about drugs, except the drug makers. So you end up with a situation where patients can freely share anecdotal experiences of uncertain veracity, while manufacturers incur huge risks by jumping in with facts and education.

At PRSA Health Academy this year, one speaker noted that in survey of top 10 drug makers, each claimed to be "the most conservative"

Can you blame them? Without clear rules, guidelines and principles, no good deed goes unpunished. Which brings me back to the question raised in this post's title, just whose interests FDA is fighting for? Hardly consumers. Certainly not the industry. Nor the medical professions. FDA has become unwieldy unaccountable bureaucracy, more interested in appearance of action than in actual positive impact. In recent interviews and statements, FDA and DDMAC representatives clearly demonstrated lack of curiosity and understanding of the changes happening in the media. This failed agency needs radical reform and new blood.

Who will hold FDA accountable for restricting flow of information and hurting competitiveness of American pharma industry?