Healthy Skepticism Library item: 12089

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

Roehr B.
New US charity to foster drug research sparks fears of undue industry influence.
BMJ 2007 Nov 24; 335:(7629):1069
http://www.bmj.com/cgi/content/extract/335/7629/1069-b

Abstract:

A new charitable foundation that was set up to promote collaboration in research between the US Food and Drug Administration and the drug and medical device industries has sparked concerns that it will undermine the FDA’s independence.

The Reagan-Udall Foundation, which will be headed by Mark McClellan, who at one time led the Food and Drug Administration and later the federal Medicare and Medicaid health insurance programmes, was spearheaded by the Democrat senator Ted Kennedy in a bid to reform the FDA.

The foundation’s creation should shorten the time it takes to develop new drugs, ultimately reducing the cost to patients, he said.

An initial focus of the foundation is likely to be on the development, standardisation, and validation of biomarkers of drug safety and efficacy.

Companies have in the past been reluctant to share such basic research information with competitors. But they now realise that developing the next generation . . .