Healthy Skepticism Library item: 19482

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Mack J
Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.
Pharma Marketing Blog 2011 Apr 5
http://pharmamkting.blogspot.com/2011/04/brits-beat-fda-phrma-issue-social-media.html

Full text:

The Brits have won the race to issue social media guidance for the drug industry! (OK, it’s NOT a race. Still, everyone says the EU regulators FOLLOW FDA’s lead. Here’s a case where the horse is following the cart!)

The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), just published “informal guidance” providing the drug industry advice on how to use online communications.

You can access the PMCPA “informal guidance” here.

While the US FDA (PhRMA too!) twiddles and delays, the British PMCPA tweets and delivers!

Most of the advice, however, is merely to follow the existing ABPI Code of Practice, which “applies irrespective of the method of communication.” NOTE: In contrast to the British industry code, US PhRMA’s DTC Guidelines specifically excludes online communications.

Regarding Twitter, PMCPA has this to say:
“If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code.
“Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine.”
I interpret that to mean that Tweets such as the following from Boehringer Ingelheim (BI) may not pass muster with the Brits:

Back in October, 2009, I criticized tweets like this, which I thought violated FDA regulations (see “Boehringer’s Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did”). So far, however, FDA has not issued any NOV letters to companies who post such tweets. Maybe BI is out of the FDA’s jurisdiction because the tweet was meant for an EU audience and not a US audience? And since BI is not a British Pharmaceutical industry, it is not obligated to comply with the ABPI Code.

While many industry pundits fault the FDA for not issuing social media guidance in a timely fashion, no one has put any blame on PhRMA (the US industry equivalent of ABPI) for not issuing its own voluntary industry guidelines regarding Internet and social media pharmaceutical promotion. No one but me, of course (see, for example, “PhRMA Finalizes DTC Principles”).