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Published on 25 May 2010

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EMEA approval process questioned

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A leading journal has attacked the European medicines regulator for approving allegedly dangerous drugs without fully disclosing their side-effects.

The Lancet called for greater transparency and challenged the means by which the European Medicines Agency (EMEA) made a selection of its licensing decisions.

An editorial in the latest issue criticised the watchdog for not releasing extended information on Roche’s controversial acne drug Accutane which, while powerful at clearing the problem, has been linked to birth defects if taken during pregnancy and is suspected of causing mental health problems.

The EMEA says it is under no obligation to release serious adverse reaction reports, but the European Ombudsman recently called on the agency to reconsider its position – an idea supported by the Lancet.

“Citizens of EU member states should welcome and support transparency initiatives within EMEA, which might bring about more openness on licensing decisions and suspected adverse reactions,” the article said.

The criticism is reminiscent of past attacks on the U.S. Food and Drug Administration.

Copyright Press Association 2010
The Lancet



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