FDA Warning Letters Leave Pharma Industry Dazed & Confused
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.
April 17th, 2009 at 3:24 pm
[...] Johnmar at Envisioning 2.0 say the FDA’s warning letters over online advertisements that link to product Websites have left pharm…. “While industry executives are perplexed by the new warning letters, one can look at this [...]
April 17th, 2009 at 6:29 pm
Fard,
I actually don’t think that the FDA is open to dialog on this issue. There has been an arrogance about the decision expressed in a number of ways, including statements that the year’s long practice was discovered through “routine surveillance” that they keep repeating that betrays a bureaucratic intransigence and a belief that we all must be idiots. Secondly, they have often used Eye on FDA podcasts as a means to express their point of view and get their messages across in the past (like when Congress accused them of withholding information), when I asked them to do a podcast about the 14 letters, they refused. That indicates to me that they (1) realize what a huge mistake this was to regulate by caprice rather than principle and (2) that they cannot answer the hard questions that naturally arise as a result of this regulatory faux pas.
Mark
May 1st, 2009 at 10:31 am
Mark:
I’m sorry it’s taken me a bit of time to get back to you re: your comment. It’s unfortunate to hear that the FDA is taking this stance. I’m hoping that more flexible individuals within the agency have the opportunity to speak on this issue.
Fard