Medicines Control Agency slated by Commons committee

Debashis Singh, BMJ

The former Medicines Control Agency has received a damning blow from the House of Commons Committee of Public Accounts.

The committee’s report, Safety, Quality, Efficacy: Regulating Medicines in the UK, criticises the agency for its “lack of dynamism” in improving public health and for its “non-existent” public profile, which made it difficult for it to function as a provider of safety information.

The agency was, until earlier this year, responsible for protecting public health by ensuring the safety, quality, and efficacy of the one billion medicines that are prescribed and sold over the counter in the United Kingdom each year. It inspects manufacturing and supply facilities and monitors the risks and benefits of existing medicines.

The agency was set up in 1989. In April 2003, it merged with the Medical Devices Agency to form the Medicines and Healthcare Products Regulatory Agency, which now inherits the responsibilities of the Medicines Control Agency.

The committee looked at the Medicines Control Agency’s performance against its key objectives of promoting and safeguarding public health through the regulation and provision of information on medicines, and its service to stakeholders.

The report was critical of the poor quality of information leaflets and labels, designed to alert patients and doctors to potential risks of medication, and the low level of reporting of adverse reactions to medicines by doctors. These were cited as evidence of the lack of dynamism to drive further improvements in the protection of public health.

The report added that the widespread but unmonitored practice of prescribing drugs to children that, although licensed, were not specifically approved for paediatric use was also cause for concern.

The committee also highlighted the irony that an agency whose mission was to put across safety messages to the public had a non-existent public profile. Even doctors had little awareness of its role. Unlike the US Food and Drug Administration, the agency failed to embrace advertising and awareness campaigns necessary for developing a relationship with the public, says the report.

The committee hopes that the creation of the Medicines and Healthcare Products Regulatory Agency will be a good opportunity to rectify some of the failings of its predecessor. It wants to see the new body develop training for doctors on monitoring the safety of medicines, as well as establishing an effective communications and awareness strategy for conveying safety messages both to the public and to health practitioners.

Edward Leigh MP, chairman of the Committee of Public Accounts, said: “It is simply unacceptable that the agency’s efforts to drive improvements in the protection of public health have been so lacklustre.”

Safety, Quality, Efficacy: Regulating Medicines in the UK (26th report of session 2002-3) is available at:

Source: BMJ 2003; 327:10 (5 July)

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