This blog entry, is a continuation of two (2) previous entries. It will be discussing specific themes, and the likely position of the FDA relating to these specific themes as explained below.
Themes:
Due to the continually changing nature of the Internet, the FDA has indicated a reluctance to address its guidances specifically to how a promotion on twitter or facebook should look, and will instead address themes such as “responding to unsolicited requests”. The expected, aforementioned guidances from the FDA are therefore expected to be “platform independent.” The following section details what we know, and theorizes on what the FDA is likely to propose in the coming weeks and months.
Medium neutrality
As previously mentioned, the rules haven’t changed. The FDA has indicated a continued desire to regulate, as it always has, the content and not the medium of distribution. The internet is, in many ways, like a combination of a television, radio, and print promotional piece, with the interactivity of an individual sales person. The FDA has outlined, in its guidances, how it treats, television, radio and print promotional pieces. It has also outlined interactivity, to the extent it was relevant at the time, to the activities of sales people and medical liaisons. In light of the FDAs expressed opinions that it is unlikely to change its requirements, based on the mode of distribution of information, the FDA is unlikely to steer wide of those previous recommendations.
Whatever your consumer sees.
There have been several commentators who have reviewed the FDA warning letters and asserted that the Tasigna FDA warning letter[2] has allegedly “changed the rules” since it looks at meta data. I believe that it is too soon to tell if the rules have genuinely changed.
Meta data, in general, is usually information that is not visible to the general public unless certain unusual acts are taken (such as reviewing the code itself). There is, however, another class of meta-data, that is usually kept away from the public until such time as the intended audience acts in a way, desired by the promotion designer, that would force the reveal of this “hidden” information. The meta-data in question, in the Tasigna Warning Letter, was of the second type.
In the Tasigna Warning letter, the meta-data in question, when revealed by the audience, resulted in writing that the FDA deemed to be “misleading” because “it [made] representations about the efficacy of Tasigna but [failed] to communicate any risk information associated with the use of this drug.” This seems entirely consistent with the FDA’s position that misleading information would be considered to be worthy of its attention and enforcement power. There is no indication that this was in any significant way different from several other DDMAC enforcements over the years. The takeaway continues to be: the FDA expects a fair balance of risk and benefit information.
Reporting adverse events as reported online
As previously indicated, the FDA has typically required that to report individual adverse events, typically referred to as an individual case safety report or “ICSR”, the following minimum information must be available: (1) and identifiable patient (2) an identifiable reporter (3) a suspect drug and (4) a description of the event.[3] If these criteria are met, the adverse event is generally reportable. Considering the anonymous nature of the internet, these criteria may often not be satisfied since the reporters and/or patients may use anonymous identities that would preclude a pharmaceutical company being able to contact the appropriate reporter/patient for further information. Nevertheless, it is expected that if all the information is provided, the ICSR must be appropriately filed.
The next entry will relate to what is not likely to be regulated by the FDA, and conclude with some advice for sponsors on who they may want in their next marketing meeting.
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