MHRA to ask for child data
Data on the use of medicines in children are to be sought from pharmaceutical companies by the Medicines and Healthcare products Regulatory Agency.
Speaking at the Association of the British Pharmaceutical Industry annual
dinner on 1 April, Parliamentary Under-Secretary of State for Health,
Lord Warner, said that American incentives for research into medicines
for children had led to companies submitting data on a range of products
to the Food and Drug Administration. But even though 90 of the products
concerned were available in the UK, data on less than two-thirds of them
had been sent to the MHRA. Lord Warner said that he had asked the agency
to write to the companies concerned to ask for the information.
Referring to European plans to encourage research into children’s
medicines (PJ, 20 March, p341), Lord Warner said: “There are steps
we can take now in the UK that will improve the situation for children
and will also get us ahead of the game when the European Regulation comes
in.”
Ian Wong, director of the London University School of Pharmacy centre
for paediatric pharmacy research, told The Journal that availability
of the US data would make it unnecessary to repeat clinical trials in
the UK. He said: “It’s good to be able to use the data from
the US. It’s good news for children, but there are differences
between how we use medicines and how they are used in America and in
the population affected.”
An ABPI spokesman said that the MHRA was free to ask for the data, but
it could not insist on it. But he added: “Our attitude is that
if companies have data and it is relevant then they should share it.” |
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