Showing posts with label PMCPA. Show all posts
Showing posts with label PMCPA. Show all posts

Friday, January 27, 2012

Allergan "Badly Let Down" by Employee Tweet

The Prescription Medicines Code of Practice Authority (PMCPA) ruled that Allergan breached UK pharma's self-regulatory Code of Practice because an employee accidentally tweeted publicly about Botox (read the details here "Brits Versus Botox Tweet").

Basically, an employee sent a public tweet to a friend in which he/she mentioned Botox and said "... we could do something around stroke rehab..." That was considered advertising to the public, a no-no in the UK and the rest of the world outside the U.S.

But PMCPA showed compassion saying that it noted that Allergan had a policy that clearly stated "no Allergan employee might comment in a social media forum about Allergan products or business activity."

PMCA added "The Panel considered that Allergan had been badly let down by its employee."

I sure would like to see Allergan's "Global Social Media Policy." I wonder if it is similar to Pfizer's infamous "social media playbook?" (see here).

Maybe Elya Zarra, who is currently part of Legal Department - Regulatory Affairs/Compliance at Allergan would send me a copy. Part of her duties include "Development and implementation of internal policies and strategies, including a global social media policy" (see her LinkedIn profile). I can't send her a direct message through LinkedIn because she requires contact only through her LinkedIn friends. And she doesn't have a Twitter account that I can find. Perhaps it's against policy for her to have one.

Wednesday, September 21, 2011

BI Masters the Art of WOM through Its "Parrots," er, Spokespersons

Even Social Media Savvy, Personable, Fun-Loving Boehringer Ingelheim (BI) Can Bring Shame to the Pharmaceutical Industry!

No sooner did I give Boehringer Ingelheim (BI) kudos for its recent humorous and playful YouTube video (see here), than I learned it violated Clauses 2, 9.1, 3.2, 22.1 and 22.2 of the ABPI Code of Practice (see "Promotion of Pradaxa by Boehringer Ingelheim Breached ABPI Code of Practice").

You can read the details yourself in the above link. At the core of the case were stories published in UK newspapers based upon a BI press release. BI also provided reporters with access to paid physicians and patient spokespersons.

The case originated from a complaint by a "general practitioner" filed with the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the ABPI Code.

The PMCPA "was very concerned about the content of the press release and the briefing material for spokespersons. The [PMCPA] Panel considered that these would in effect encourage members of the public to ask their health professional to prescribe a specific prescription only medicine. The Panel was concerned about the lack of information in a consumer press release relating to side effects."

In the YouTube video mentioned above as well as in a recent tweet, BI said it "believes there are better mktg tools than FB & Twitter." It appears that BI thinks friendly news reporters are among the better tools available to it.

It's amusing that the news articles made some great marketing statements that BI could never make, such as referring to Pradaxa as a "super pill" and a "revolutionary drug." The stories also dissed the competition (warfarin) by referring to it as "rat poison." BI press materials did not refer to warfarin as rat poison and "otherwise made no disparaging remarks about the medicine," said PMCPA, which had no evidence about how warfarin had been described by Boehringer Ingelheim’s spokespersons or at any press conference. Therefore, no breach of the Code was ruled in that regard.

Obviously, what "spokespersons" say falls under "word of mouth" (WOM) marketing, which is what BI says is one of those "better mktg tools than FB & Twitter." As this case demonstrates, it is very hard to prove that pharmaceutical companies are responsible for WOM marketing that violates regulatory and industry rules.

Tuesday, April 5, 2011

Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.

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").