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Healthy Skepticism Library item: 14872

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: news

FDA Sends Abbott Letter About Humira
PharmaLive 2008 Dec 24
http://pharmalive.com/news/index.cfm?articleID=594701


Full text:

The FDA posted on its web site yesterday a letter it sent to Abbott Laboratories about a review of an American Academy of Dermatology (AAD) Post Meeting News Ad for Humira. According to the FDA, “This AAD Post Meeting News Ad broadens the approved indication and minimizes the risks associated with the use of HUMIRA. Therefore, this piece misbrands HUMIRA in violation of the Federal Food, Drug, and Cosmetic Act .”

 

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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.