Advertising and Promotion

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. 

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Cuba stands out as the only country in this group that permits neither dmg advertising nor dmg promotion. Instead, pharmaceutical products are distributed and product information disseminated within the Ifamewoik of the centralized State-mn management system. Misinformation for commercial purposes is therefore not an issue in Cuba. In all the other survey countries, both the content and the conduct of dmg advertising and promotion are regulated. The basis of such controls is found in dmg legislation. 

Which monitoring approach is more effective Generally speaking, an active approach allows more systematic and thorough monitoring of advertisements and promotion activities. In practice, its effectiveness depends on how it is done, and what happens after a violation has been identified. If active monitoring is carried out only sporadically, with minimal in-depth examination of dmg advertisements and promotion, it is unlikely to be effective. If there are no sanctions, or only small fines are imposed when a violation is discovered, then the deterrent effect is minimal. For example, a pharmaceutical... 

The system provides no incentive for cost reduction, as it generously allows expenses incurred through advertising and promotion, or inefficiently managed R D programmes, to be transferred to prices. Furthermore, the system allows more expensive products to transfer more advertising and promotion expenses to prices. 

The information requirements to establish justified costs in certain items such as R D and advertising and promotion are numerous, as a result of which the administrative costs of the regulation system can be high, given the existence of information asymmetry between regulator and regulated. 

The price index is adjusted periodically according to an adjustment factor that is pre-established and exogenous to the company during the lifetime of the regulatory contract, but can be established on the basis of the fulfilment of certain policies by the company in the previous period (for example, R D policies, limits on spending on advertising and promotion and so on). 

Advertising and promotional claims relating to the above product types... 

Medicines Control Agency. Advertising and Promotion of Medicines in the UK (MHRA Guidance Note No. 23). London MHRA, 1999. 

The important first principle with regard to advertising and promotion is that it cannot be imdertaken in respect of any unauthorised product. Not only does this include products in respect of which there is no authorisation to... 

The Venereal Disease Act of 1917 and The Cancer Act of 1939 had already prevented public advertisement and promotion of drugs for these conditions to protect sufferers from inadequate or unsuitable treatment and fraudulent claims (of efficacy). 

It should be noted that the Medicines and Healthcare products Regulatory Agency s guidance notes on advertising and promotion state that each page of an advertisement for a prescription only medicine should be clearly labelled as intended for health professionals. 

Monitor advertising and promotion of medicines, and provide independent information on their rational use to the public and professionals... 

The advance has two major purposes. One is obviously to ensure that the author gets a certain amount of money. Often, an author never gets a dime more than his advance. A second purpose is to ensure that publishers devote some effort to promoting the book so they can at least get back their advance money. A significant advance would seem to guarantee a certain level of commitment to the book. Dean Koontz has noted that publishers push hard with advertising and promotion only on those books on which they were at risk of losing money. 

For example, Celanese announced Celcon acetal copolymer in February 1961. By the last half of 1962 and the first half of 1963 we carried through on a specific advertising and promotion program which consisted of ... 

Do they offer any value-added services Will they help with advertising and promotion, provide inventory reports and analyses, or assist with pharmacy layout and design Do they offer a private-label line of products ... 

Draft Guidance Providing Regulatory Submissions in Electronic Format-Prescription Drug Advertising and Promotional Labeling. Optional format PDF. (Issued January 2001, Posted January 30,2001)... 

Before approval of the label, the FDA negotiates with the pharmaceutical company concerning its contents. After approval, the label appears in package inserts. It is published by the drug companies in the Physicians Desk Reference (PDR), a commercial book sent free to all practicing physicians and found in most treatment facilities and doctors offices. A shortened form of the label with emphasis on adverse effects must be included in advertising and promotional materials. 

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