Last Updated Jul 6, 2011 2:11 PM EDT
The apology, to be published in the August review of the U.K.'s Prescription Medicines Code of Practice Authority, came after Bayer published two comments on Twitter, in March 2011 and June 2010, that did not appear to have been written by lawyers or compliance officers. One referred to Bayer's new melt-in-the-mouth version of Levitra:
It seems trivial because it is. But tweets, status updates, Facebook "Likes" and other forums in which a drug company's "official" social media pages can include thousands of added, unapproved comments from members of the public, are proving a huge headache for the highly regulated, risk-averse and deeply conservative world of Big Pharma.
The tweet was an extract of a press release that had been internally "certified" by Bayer's compliance people, but the PMCPA, which regulates drug promotion in the U.K., said that wasn't good enough. As the tweet promoted a prescription drug to the public -- which is illegal in Britain -- it was in violation. Bayer apologized for what is apparently the first violation of Britain's social media code for pharmaceutical companies:
In accepting breaches of Clauses 22.1 and 22.2, for which Bayer extended its sincere apologies to the PMCPA, Bayer referred to the rulings in Case AUTH/2355/9/10 in the hope that its tweets were not such as to require the Panel to rule a breach of either Clauses 9.1 or 2.Bayer's U.K. and Ireland Twitter stream is available in the U.S., of course, where drug promotion to the public is legal. But the tweets still could have run afoul of FDA regulations which require companies to list safety and risk information every time they make claims about a drug's efficacy. The Levitra tweet said the treatment was for ED, thus making such a claim.
Bayer -- and its rivals -- will throw up their hands in dismay. Facebook recently ended its policy of allowing drug companies to maintain Facebook pages that banned comments, forcing drug companies to engage in unregulated conversations with consumers. The entire industry awaits policy guidance on social media from the FDA, whose "review" of new digital communications is now in its third calendar year with no final report in sight.
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