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Healthy Skepticism Library item: 6780

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

Ault A.
US FDA ordered to allow off-label data dissemination
Lancet 1998; 352:555


Abstract:

The U.S. Food and Drug Administration has barred drug companies from sending unsolicited articles to physicians on off-label uses of their products, but this policy may soon be overturned.

Keywords:
*news story/United States/FDA/Food and Drug Administration/regulation of promotion/ reprints/ unlabeled indication/ doctors/PROMOTIONAL TECHNIQUES: UNLABELED INDICATIONS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION

 

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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.