Key Topic 2: Response to an External Request
Sometimes health professionals may ask a company for information about unlicensed medicines or indications. These may be responded to through Medical Departments (usually Medical Information or Medical Science Liaison (MSL) staff) provided that certain conditions are met. Written responses from Medical Information do not require Nominated Signatory review but you may be asked to review materials such as slide sets for use by Medical Science Liaison staff.
Sharing of off label information by medical personnel such as MSLs must always be non promotional in nature, and must not occur in a setting that might be deemed promotional. There are many examples where companies have utilised non promotional roles such as the MSL in a manner which has subsequently been deemed to be promotional.
Click on each of these conditions for more information:
- The enquiry must be unsolicited
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This means that the enquiry must come without any prompting by the company. Examples of prompting would be materials offering readers further information, or placing material on exhibition stands. This includes scientific-medical stands at congresses –If materials on a scientific stand relate to unlicensed products e.g. a poster of a study design aimed at potential investigators, no enquires about the medicines that under investigation in the study can be answered on the stand, as the questions would be seen as prompted by the poster.
- Response must not go beyond the scope of the enquiry
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It may be tempting to give a wider answer to a specific question in order to be helpful – however this can be viewed as pre-licence promotion and so great care must be taken.
For example a health professional may ask whether you have any data on a specific interaction for a product. In this case it would not be acceptable to send them the details of the entire clinical development programme for the product! - The response must not be promotional
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It is a widely held belief that medical roles are inherently non promotional. This is not always the case and medical staff may be involved in promotional activities provided that they are not ‘disguised’.
Consider these examples:
Example 1
In the US in 1996 a Medical Liaison employee of Warner Lambert (Dr David Franklin) became concerned that he was being asked to take part in a company strategy to promote the product Neurontin for off-label use. The marketing plan was designed to achieve sales of Neurontin for a wide range of unlicensed indications such as bipolar disorder, attention deficit disorder, migraine, restless leg syndrome and as first line monotherapy for epilepsy.
Dr Franklin left his job and filed a lawsuit against Warner Lambert on behalf of the US government. After a lengthy investigation it was found that Medical Liaison staff had often falsely represented themselves as experts in particular diseases and had promoted off label uses for Neurontin. In addition ‘consultant meetings’ had taken place at lavish locations (such as the 1996 Atlanta Olympics and Hawaii) during which presentations were made about off label uses for Neurontin. For some of the indications promoted there was not even good supporting clinical evidence -in fact in one trial placebo was superior. Warner Lambert had also sponsored ‘independent medical education events’ about off label uses for Neurontin whereas they had in fact had extensive input regarding topics, speakers, content and participants.
Warner Lambert pleaded guilty and had to pay fines of $430 million. In addition Dr Franklin received $24.64 million (as part of a process in the US which protects ‘whistleblowers’).
Example 2
In the UK A primary care trust (PCT) head of medicines management alleged that Servier had promoted Procoralan (ivabradine) for the unlicensed indication of heart failure. Procoralan was indicated for the symptomatic treatment of chronic stable angina.
The evidence was a series of emails from a medical liaison specialist to staff at the PCT. One of the emails gave the licensed indication for the product and also mentioned that Servier had applied for a licence extension for heart failure. Another email said ‘In some areas clinicians are already using the product (off licence) in heart failure. As a consequence I felt it appropriate to make contact, to ensure that … you would have an opportunity to be brought up to date with the most recent data ...’.
On investigation the Authority found that in the previous 6 months, the medical liaison specialist in question had contacted 57 health professionals/budget holders about the use of ivabradine in heart failure.
Which of the following statement do you agree with:
- The medical liaison representative is allowed to share off label information as the PCT would need this information
- This is advance notification and so is acceptable
- The medical liaison specialist should not have proactively contacted so many people about an unlicensed indication
- This constitutes off label promotion
- This is legitimate scientific exchange in the case of medical liaison staff the sharing of such information should be reactive i.e. in response to a specific enquiry – this was proactive
Ruling
The Panel did not consider that the medical liaison specialist’s role had been non-promotional. Servier had not limited the activities to responding to unsolicited requests. The company had arranged for its staff to proactively call upon health professionals and others to raise awareness of the use of Procoralan for an unlicensed indication. The company’s activity amounted to the promotion of Procoralan for an unlicensed indication, and a breach of the UK Code was ruled. This was upheld on Appeal.
