Drug regulation procedures defended
Updated on 03 December 2008
The drugs regulator has defended its procedures after an academic in America criticised the work of various agencies around the world.
Dr David Kao from the University of Colorado Health Sciences Centre noted that the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) "is entirely funded by user fees".
These are fees that are required of pharmaceutical companies in the licensing of drugs, he explained.
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."
He points out that previous research has shown that drugs approved in the US during the two months before the mandated deadline were more likely to be withdrawn for safety reasons or to carry a warning.
He said: "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. 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."
He says in the article: "Revenues collected from industry now account for 43% of the FDA (US Food and Drug Administration) budget for drug oversight. Similarly, the European Agency for the Evaluation of Medicinal Products receives 75% of its funding in this manner, and the United Kingdom's Medicines and Healthcare Products Regulatory Agency is entirely funded by user fees."
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".
It added: "In the UK, new drugs will also be reviewed by the the UK's Commission for Human Medicines. Usually there will be questions posed to the applicant during the review, and only when the appropriate regulatory agency is satisfied that any significant issues are resolved, will approval be given. At the time of approval, the company will have an agreed risk management plan in place to ensure continued safety monitoring of the drug in clinical use in the market place."
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