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Healthy Skepticism Library item: 8722

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

Kmietowicz Z.
Repeal law that puts "FDA on the payroll of the industry," says former NEJM editor
BMJ 2007 Mar 3; 334:(7591):447
http://www.bmj.com/cgi/content/full/334/7591/447-a


Abstract:

The law that requires drug companies to pay “user fees” to the US Food and Drug Administration for every drug they submit for approval should not be renewed when it comes before Congress later this year, says a former editor of the New England Journal of Medicine.

Writing an open editorial in the Boston Globe, Marcia Angell, who worked for the journal between 1979 and 2000, most recently as editor in chief, said that the Prescription Drug User Fee Act has, in effect, “put the FDA on the payroll of the industry it regulates” (www.boston.com, 26 Feb, “Taking back the FDA”).

The act, which was passed by Congress in 1992, “put the fox in the chicken coop” and has changed the focus of the agency, which now serves the industry rather than the public, says Dr Angell.

Nearly all of the $300m (£153m; 230m) that the fees . . .

 

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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.