Promotion/information complaints

It is undoubtedly difficult for pharmaceutical physicians, even up to the level of medical director, to have an all-seeing eye as to the perceptions that may prevail in the minds of the recipients of promotional material. What may be entirely clear to the informed approver of material may be entirely unclear in the mind of the uninformed or even informed recipient. After all, if the recipient is misled, no defence is possible that says that material is not misleading. It really is essential for the approver of promotional material to stand back and say to him/herself Is what we say capable of misleading or being misimderstood . As an Appeals Board member, I would say that at least half the complaints that come to the PMCPA relate to Clauses 7.2, 7.3, 7.4 and 7.10 of the Code. These relate to accuracy, balance, fairness, objectivity, lack of ambiguity and the full reflection of the total and up-to-date evidence comparisons must be carefully and appropriately presented information claims or comparisons must be capable of substantiation. So often defences presented by companies are ill-prepared and... 

Promotional activity and the dissemination of information are so closely linked that it is hard to see where one ends and the other begins. In the modern era, where many pairs of eyes are on the industry s activities, eager to criticise and to control, the only real option for companies is to conform to the rules and to play fair. I would suggest that since companies act by SOPs for their conduct of clinical trials, so it makes sense to have an SOP for the preparation and approval of ethical promotional material. If one does not create written procedures to cover the multiple steps in the preparation and approval of promotional copy, mistakes can be made and complaints may follow. 

On a day-to-day basis, it is the more informal measures that ensure compliance with the rules, in relation to the promotion and advertising of medicines. These measures are via either the Complaints Resolution Panel (CRP), established by the TG Regulations, or the Medicines Australia Code of... 

Figure 17. Pharmaceutical companies regularly promoted tranquilizers for female patients in the pages of the Journal of Occupational Medicine, often explicitly or implicitly suggesting that menstruation was at the root of women s complaints. In this 1965 advertisement, doctors are informed that they cannot trust what their female patients report because few will confess the true menstrual nature of their complaint. Notably, such advertisements often portrayed patients as white women in middle-class dress, invoking the tensions that emerged as middle-class women left the home for the workplace. At the same time, the racing and classing of this figure suggests that this medication was marketed for prescription to office workers.

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