Subtopic: Consumer

 

Here are some statements regarding press releases intended for the consumer media. Highlight those that you believe are correct.

  • They must not raise unfounded hopes about a treatment
  • They must be factual and balanced
  • They must include prescribing information but it is good practice to include the SmPC
  • If they are about new medicines they should not be released until the medical profession has been informed this is to avoid health professionals being put in difficult situations
  • They should not contain brand names they can be used to identify the product but they should not be used to excess; usually a single use to identify the product is sufficient.
  • The date and asset identification number must appear on the release
  • They must not mislead with regard to safety
  • There should be a genuine public interest in the topic
  • They may include pack shots this is generally considered as advertising to the public
  • Patient case studies cannot be used but they must not be ‘extreme’ examples – they must be typical of the disease and response to treatment
Check answer
 
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Consider these examples

Concerta press release - newsworthy?


Jansen –Cilag issued 2 consumer press releases in Australia to announce the availability of a new product – Concerta for the treatment of ADHD. The first press release achieved ‘limited engagement’ from the media because it unfortunately coincided with the Samoan tsunami tragedy. Therefore Janssen-Cilag issued a second release with essentially the same information.

 

Janssen Cilag was found in breach of the Australian Code because the second release was not justified. In other words it was no longer ‘newsworthy’. The company received a fine of $15,000.

1050 July-Sept 2010 Australian Code

Mepact story

Takeda placed a news story on its website about the fact that its product Mepact (mifamurtide) had not been approved by the National Institute for health and Clinical Excellence (NICE) in the UK. The news story was available to the general public.

The news story contained the following phrases about Mepact:

‘NICE says no to life saving treatment for childhood bone cancer’
‘improve survival in childhood cancer’
‘save an additional eight lives each year’

It also stated that Takeda wanted to ensure that suitable young patients diagnosed with osteosarcoma were ‘provided with a fighting chance’

 
 

Which of the following do you agree with?

  • If the statements about Mepact are factually accurate then this newstory is approvable
  • These statements constitute advertising of Mepact to the public
  • These statements would be likely to encourage members of the public to ask their health professional to prescribe Mepact
Check answer Ruling
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Ruling

This was the subject of a complaint in the UK and was found to be in breach of the Code because:

  • the strong claims would be likely to encourage the public to request a prescription for Mepact
  • the nature of the claims and their placement on a public website constituted an advertisement for Mepact to the public
  • to describe Mepact as a ‘life saving treatment’ meant that high standards had not been maintained.

In this case the Panel also ruled a breach of Clause 2 of the Code (bringing the pharmaceutical industry into disrepute) because it considered that it was particularly important that information made available to the public about such a sensitive issue as survival in childhood cancer was fair and balanced and did not raise unfounded hopes of successful treatment.

(The clause 2 ruling was successfully appealed by Takeda, but the other breaches were upheld).