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Healthy Skepticism Library item: 8100

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

FDA finalizes guidance on DTC broadcast ads
American Journal of Health System Pharmacy 1999 Sep 15; 56:1815


Abstract:

The final guidance on direct-to-consumer (DTC) advertising of prescription drugs issued by the U.S. Food and Drug Administration (FDA) addressing provision of product labeling is presented; regulations specify that DTC ads must include a statement conveying the product’s most important risk information (adverse effects and contraindications), in addition to either a brief summary or adequate provision for disseminating full product labeling. The final guidance states the following expectations for broadcast advertisements: that they are not false or misleading, that they present a fair balance of information about the drug’s benefits and risks, and that the major statement of risk information and all information about the drug’s approved use are included.

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.