FDA Warning Letters Leave Pharma Industry Dazed & Confused

April 17, 2009

For many years, pharmaceutical companies and advertising agencies have been producing text advertisements that link to Websites promoting medications.  Generally, advertisers used what what was dubbed the “one click rule” – i.e., if information about the risks associated with a medication was included via a hyperlink, they would be fulfilling requirements to post information about prescription medication side effects.

No more.  Recently, the FDA issued 14 warning letters to various pharmaceutical companies demanding that they start including risk information in text advertisements.  According to the New York Times:

“When the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.”

Today, attendees at a panel with the FDA at the Direct to Consumer National Conference expressed disappointment (via Twitter) that the FDA was not more forthcoming about the warning letters.  In addition, Peter Pitts who is working for the Public Relations firm Porter Novelli said (in a comment he left on the Wall Street Journal blog):

“Guidance? What guidance? DDMAC letters should help companies understand what “in compliance” means. These letters do not. In fact, they make things more muddled. After all, “sponsored links” are by no means a new phenomenon.”

Ken Johnson, senior vice president at the industry trade group PhMRA had this to say: “Rather than regulate through warning letters, FDA could help patients and serve the public health by initiating a public dialogue and FDA guidance outlining clear standards.”

While industry executives are perplexed by the new warning letters, one can look at this situationa as a glass half full.  Demands on the FDA to issue clear and unabigious guidance on Internet and social media marketing will only increase.  I understand that people inside FDA are open to dialogue.  In my opinion it can’t happen fast enough.


Obesity Foes Use 9/11 To Tout Documentary: Brilliant or Distasteful?

April 8, 2009

Last week, on April 1 of all days, I received an e-mail from the Disinformation Company, a television, book and film production company about a new film it is releasing, titled: “Killer at Large.”  I get lots of pitches in my e-mail inbox, and generally ignore them, but this one caught my eye.  It seems that the producers of the documentary are arguing that obesity is as serious as terrorism.  From the release:

“When asked what the most pressing issue is in America today, former Surgeon General Richard Carmona responds: ‘Obesity, because obesity is a terror within. It is destroying our society from within and unless we do something about it, the magnitude of the dilemma will dwarf 9/11 or any other terrorist event that you can point out to me.’”

Clearly, using the terrorism angle is a good way to cut through the clutter.  As advertisers like to say: Carmona’s quote has stopping power.  However, while the strategy may capture people’s attention, will it turn people off to the very important message the documentary is trying to convey, that 75% of Americans may be obese within ten years?

As for me, I found the reference to 9/11 distasteful. What’s your take?  Is this pitch brilliant or distasteful?

Image Source: The Disinformation Company


FDA Issues Draft Guidance On Social Media? Not Today!

April 1, 2009

Today, my e-mail box has been burning up with astounding news from the FDA april_fool.jpgregarding social media marketing.  In a press release, which is starting to be widely distributed online, the FDA is said to be developing draft guidance on social media marketing! First, my mouth fell open in shock.  Then I remembered what day today is, April 1.  Here’s the “release”:

“New FDA Draft Guidance Aims to Improve Health Information Obtained via ‘Social Media’ Websites

The Food and Drug Administration today issued a draft guidance document designed to improve communications to consumers and health care practitioners about health conditions and medical products that they obtain on ’social media’ Websites such as Facebook, YouTube, Twitter and online bulletin boards. The guidance is the result of FDA research and policy development, and was influenced by the success of the recent social media based peanut recall program (see http://tinyurl.com/d3lvag).”

This is a clever ploy by my fellow blogger John Mack of the Pharma Marketing Blog to drive traffic to his Website and get folks buzzing about the new “guidance.”

I took some time to call one of my contacts in the FDA’s media relations department today about this release, Rita Chappelle.  She is aware of every FDA release that crosses the wire.  She told me: “We have not issued any releases today.”  Check out the FDA’s newsroom to confirm her statement – as of 1:30 p.m., Eastern.

Also, careful examination of the “release” reveals that the telephone number listed regarding media contracts is incorrect.  In addition, FDA always provides specific contacts on all releases who can field media requests.  Finally, the FDA does not use TinyURL links in its official communications.

So, stop distributing this release to your colleagues.  You’ve been had.  April Fools!