Key Topic 1 - Subtopic 3: Interactivity
Interactivity (e.g through chat rooms, live webinars, blogs) poses additional challenges. Wherever possible content in interactive media must be proactively moderated prior to publication. Where ‘live contributions’ can be made there is a danger of statements being made that do not comply with regulations. In addition, if adverse events are mentioned, companies have a duty to follow up and report on these in the usual manner. Companies often avoid such activities because of the practical difficulties of ensuring compliance.
Blogs in particular can cause these types of issues. Although not specifically banned, the UK Code authority advises against using them:
“Given that, by their very nature, blogs are for contributors to freely and spontaneously express their personal views on a subject, pharmaceutical companies should not sponsor such sites on the Internet if they were intended, or could reasonably be expected, to discuss medicines and their uses as it would be impossible to guarantee their compliance with the Code.” PMCPA 2015
It is therefore essential that all Company interactive digital media communications, where health professionals or others can contribute information, should be subject to clear procedures that identify Company staff responsibilities and actions to be taken in the event of possible issues.
Consider these examples
Example 1
In the UK a complaint was made about a website posting by Pfizer on ‘BMJ Rapid Responses’.
The posting was made by Pfizer’s UK Medical Director and it was made in response to an editorial in the BMJ entitled ‘Switching statins’.
The subtitle of the editorial read ‘Using generic simvastatin as first line could save £2bn over five years in England’.
The response corrected some factual inaccuracies in the editorial.
The complainant alleged that the response was promotional and therefore required prescribing information and adverse event reporting information. The complainant was also concerned that BMJ Rapid Responses were not peer reviewed and that they were open to the general public.
Pfizer submitted that the response was a fully referenced scientifically balanced response to correct the errors of fact in the BMJ’s editorial.
Which of the following do you agree with?
- Pfizer’s medical director should not have used this digital channel to correct the editorial as any mention of one of Pfizer’s products would be promotion the Panel did not consider this as promotion – the response was factual, accurate and balanced and did not go beyond the topic in question
- If the public could access this, it could be seen as promotion to the public some medical journals are accessible to the public, but it is generally accepted that their intended audience is clear
- This is disguised promotion in this particular case the response was not deemed promotional because it was factual, accurate and balanced and did not go beyond the topic in question. If the response had been considered promotional in tone or content then this could have been the case.
Example 2
US website (Surfaxin example)
Here is some information about the product:
SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Surfaxin reduces the incidence of RDS at 24 hours and mortality due to RDS.
In addition the PI for Surfaxin contains warnings and precautions regarding acute changes in lung compliance, administration-related adverse reactions, and increased serious adverse reactions in adults with Acute Respiratory Distress Syndrome (ARDS). The PI also indicate that the most common adverse reactions associated with the use of Surfaxin are endotracheal tube (ETT) reflux, pallor, ETT obstruction, and the need for dose interruption.
Find out more in the Surfaxin Pdf
How many flaws can you spot? Check yours answers against what the FDA found. Surfaxin Letter
