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Paediatric trials to be mandatory in US

Published on 31/10/03 at 11:52am

Plans to make clinical trials mandatory for all drugs intended for children are progressing in the US.

The Paediatric Research Equity Act would restore FDA powers to demand pharmaceutical companies conduct paediatric trials which were taken away from the agency by an October 2002 court ruling.

FDA Commissioner Mark McClellan and Secretary of Health and Human Services Tommy Thompson have been behind the new legislation, which they say is needed to "close the gaps" in guaranteeing testing of products for children.

"Many of the innovative pharmaceutical products now being developed are likely to be used in children. But medicines to be used by children should undergo specific paediatric testing, and not simply rely on adult tests," Mr McClellan and Thompson said in a joint statement.

"This testing is needed both for new drugs and also for already-approved drugs that may be prescribed for children but still lack paediatric testing".

The new law does, however, allow paediatric testing to be postponed if it would delay the adult version of the product coming to market, an important concession from Mr McClellan who is keen to see approval times remain short.

In many cases, drugs must be tested on adults or older children before it can be tested on younger children, something which the proposed law also takes into account.

Pharma companies can apply for exemption from the rule in certain circumstances, such as if a drug is unlikely to be used by a substantial number of children. Where exemptions are granted because a drug is ineffective or unsafe for children or infants, then this information must be included in the product's labelling.

Pfizer's antibiotic Zithromax, Novartis' muscle relaxant Lioresal and Leo's diuretic Burinex, are among 12 currently marketed drugs which the Department of Health and Human Services says must also be urgently tested because of concerns about their safety.

The FDA recently advised doctors that GSK's antidepressant Paxil (Seretide) should not be prescribed to children, even though it has not yet concluded its review of new data. The FDA said there was no evidence that the drug was effective in treating depression in minors.

Stephen Edwards, President of paediatrician organisation the American Academy of Paediatrics, said; "When it comes to protecting the health and safety of children, it doesn get much better than this".

"The Senate gave back what should never have been taken away, the guarantee that the medicines our children take will be rigorously tested".

The Act has been cleared by the Senate and now moves to the House of Representatives.

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