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Published on 3 December 2008

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Regulator “funded by drug firms”

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Questions over the funding of drug regulation by the pharmaceutical industry itself have been raised by Dr David Kao, from the University of Colorado Health Sciences Centre.

In an article published on bmj.com, he said: “Critics have voiced concern over the dependence of regulatory agencies on drug companies for operational funding.

“I think the overall scenario is fairly similar between the US and EU and UK, in terms of the regulatory bodies for pharmaceuticals being somewhat dependent on the industry for funding.

He notes that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) “is entirely funded by user fees” – money paid by drug companies during the licensing process.

“This has raised questions that have not been clearly answered, about whether it impacts the review process in terms of how strict it is.

“Part of the reason that regulatory bodies have moved that way is because there wasn’t sufficient public funding to do the job. So it’s Catch 22 – if we restrict the industry funding of regulatory bodies, the approvals process will be quite slow.”

The MHRA said in a statement that before any drug can be approved, “it will receive a very thorough review of its quality, safety and efficacy conducted by an appropriate regulatory agency”.

Copyright Press Association 2008

bmj.com



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