Thursday, May 28, 2009

Uh, Oh! Will FDA Cite this "One-Click Rule" Twitter Post by AZ as Violative?

Remember the 14 Notice of Violation (NOV) letters that FDA sent to 14 drug companies citing their Adwords -- paid search engine ads -- for violating FDA regulations? At issue was (and still is) the so-called "One-Click Rule," which states that an online Rx drug ad can mention the brand name and the benefits (indications) without including all or any of the major side effect effects (fair balance) as long as the fair balance is just one click away (ie, on the landing page). See "The 'One-Click Rule': Rant or No Rant?" and "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!" for my long-standing criticism of the "One-Click Rule."

The FDA letters only focused on paid search engine ads where there is a limit of about 70 characters. You can feel some empathy for pharma marketers in that case because of the impossibility of fitting all that fair balance into 70 characters -- impossible!

But what about the 140 characters allowed in Twitter posts? Is the FDA looking at that?

Below is an example of two Twitter posts made by AstraZeneca US on March 29, 2009 -- a few days before the 14 letters were sent (BTW, AZ was not one of the companies that received a letter that day).

(Click on image for an enlarged view.)

These Twitter posts ("tweets" include the brand name of the drug (Crestor) and the indications (eg, "reduce CV risk" and "reduce risk of blood clots in the veins"), but not the side effects. Both tweets link to AZ press releases that contain all the risk information.

BTW, you'll also find links to these press releases on the AstraZeneca (US) web site here. These links also mention the brand name and benefit without mentioning side effects.

This raises a couple of interesting questions:
  1. Are Twitter posts considered promotions that are subject to FDA regulations?
  2. What about links to press releases on drug company web sites?
I guess we'll have to wait for FDA to issue more letters before we can learn what its thinking is on this!


  1. Anonymous9:42 AM

    Might be a bit of a strawman you have taken this too here. The tweets/release links pointed out would be considered scientific exchange since they report study results... SciExhas always been viewed differently than product promotion/advertising. Now the FDA also does not clearly define what is considered scientific exchange versus promotion but I think thats a different bag of worms.

    Now lets say for some reason the company continually posted similar tweets (once a week or something) after the initial information was released, that might become an issue of promotion in the FDA's mind.

  2. Thanks for your comments. Some good points about which it would be nice to have some FDA guidance.

  3. No question these are violative. I pointed these out in a presentation I did about a month ago called Pharma and Healthcare Social Media Principles. I first noted that AZ was being "conservative" using Twitter only to really post press release items. I then noted these same two tweets and commented that it was ironic that in their goal to be conservative, they managed to violate rule one of DDMAC. No drug name and indication without fair balance.

    Here's a link to the presentation:

    Check out slides 21-23.

  4. Jonathan,

    Thanks for pointing this out. Your presentation was where I found out about this, but I did not want to use your name in case what I said came back to bite you in the behind! But since you volunteered...

  5. I say no. I think it's okay. They aren't promoting the benefits, but pointing to a study that evaluates them. I think this is a fine line, but clearly on the right side.

    In the analysis my team did on this issue we took a pretty conservative line on what's okay and what isn't. I think this falls fairly safe -- risky -- but acceptable.

    I linked my name to the whitepaper for the interested.


Related Posts Plugin for WordPress, Blogger...