Promotion materials

Monitoring and approval of information provided on leaflets and promotional material... 

Ensuring that labelling, packaging and promotional material is truthful, informative and not misleading and... 

The regulations also address the need to ensure that drug information provided by pharmaceutical firms is truthful, balanced, and accurately communicated. As such, it must be consistent with the indications for use and the established performance and limitations. In Europe, the directives do not impose a specific requirement to review advertising or promotional material before it is released. Acceptable standards may be achieved via voluntary codes of practice and self-regulation. However, national authorities must monitor such material and should have the power to act where the need arises. In the U S, the F DA must vet advertising and promotional material before it is released. 

Estonia Samples of promotional material are checked Complaints by competitors are followed up. Revocation of registration, issuance of mandatory precepts, fines (US 4 300-7 100)... 

A drug whose labeling or promotional materials makes reference to a specific device or generic class of devices ordinarily remains a drug regulated by CDER. It may, however, also be subject to the combination products regulation. 

It should also be said again that casein, the complete protein (in terms of its amino acid content), was obtained from milk. Whether highly purified by the Merck Co. or not (as in "protene"), we have noted Hopkins i ns i stence that only hot alcohol could extract the growth substances completely. Casein, Hopkins believed, could also adsorb trace amounts of these substances. McCollum, Drummond and Osborne and Mendel would all demonstrate that lactose, also obtained from cow s milk, adsorbed variable quantities of growth promoting materials. (Anyone who has left a... 

The MCFC has some disadvantages, however the electrolyte is very corrosive and mobile, and a source of CO2 is required at the cathode (usually recycled from anode exhaust) to form the carbonate ion. Sulfur tolerance is controlled by the reforming catalyst and is low, which is the same for the reforming catalyst in all cells. Operation requires use of stainless steel as the cell hardware material. The higher temperatures promote material problems, particularly mechanical stability that impacts life. 

The pharmaceutical physician provides a medical direction to marketing strategy and ensures that product literature and promotional material are legal and factually accurate. This is an important contribution to the medical department s role as medical conscience, as discussed in Section 10.2. Medical input remains necessary to the servicing and support of marketed products throughout their life cycle. 

Other responsibilities include applications for regulatory approval of clinical trials and ensuring that promotional material for a product is in line with its licence. 

The issue of any promotional material that is not in accord with the MA, is inconsistent with labelling approved by the regulatory authority and is misleading is a criminal offence imder the Medicines Act (1968) and carries financial penalties and potential for a custodial sentence. Conviction of such an offence usually leads to erasure from the Medical Register by the General Medical Council (GMC). 

The Appeal Board has a dual role, acting over the activities of the Code of Practice Panel and the PMCPA as both an appeal body and as a supervisory body. All complaints received by the Authority and all rulings by the Code of Practice Panel are reported to the Appeal Board, thus ensuring independent scrutiny from outside the pharmaceutical industry of both the authority s and the panel s activities by the independent members and independent chairman of the Appeal Board. Where promotional material or activities are ruled in breach of the Code, the company concerned must cease to use the material or cease the activity in question forthwith and provide a written undertaking to that effect. Reports on all cases under the Code of Practice are also published, naming companies ruled in breach of the code. These reports receive wide coverage, particularly in the pharmaceutical press and occasionally find their way into the lay press. 

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... 

Finally, one can only advise those who are called upon to generate, review and approve promotional materials to stand back sometimes and think objectively about how the recipient of promotion will think about what is said or written. Certainly one s best chance of avoiding being found in breach of the code lies in doing this and also in using Joan Barnard s excellent little book The Code in Practice, recently reprinted. ... 

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. 

Where a company suspects that the product is to be used in a way that is not safe for patients, its duty to those patients may involve warning the doctor that it considers the proposed use to be hazardous and, if necessary, refusing or terminating supply. While there is no general obligation to provide product information with unlicensed medicines (and, as noted above, the use of promotional material is prohibited), from a product liability standpoint, the provision of basic safety information about the product is a sensible precaution. 

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