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US regulator looks to improve communication strategy

Published on 13/12/05 at 12:00pm

The FDA is investigating ways of improving its communication of the risks, including dangerous side-effects, linked with prescription drugs.

The US regulator is holding a two-day public meeting in which it will gather feedback on the strengths and weaknesses of the current system, with the aim of creating a more informative agency for healthcare providers and patients.

"We intend to use the public feedback we receive at this meeting to advance our understanding of the effectiveness of our current efforts and to develop new tools to hone our ability to inform the public," said Andrew von Eschenbach, acting FDA commissioner.

The meeting comes at a troubled time for the US regulator, which has been maligned for its handling of a number of issues, chiefly the safety scares over antidepressants and Vioxx.

The US regulator has also been criticised for its approach towards the pharma industry, which one Senate member accusing it of shielding rather than disclosing information.

The FDA's Center for Drug Evaluation and Research (CDER) is now looking to address some of these criticisms by inviting feedback on six key issues in its communications strategy.  

These include the strengths and weaknesses of the current system; the value of its communication tools for people with low health literacy skills; and the effectiveness of its internet-based sources of drug information.

It will also assess the ways it communicates drug risks, including patient and doctor information sheets and press releases.

The CDER currently directs nearly 50% of its resources towards drug safety and the US regulator is undertaking a number of other initiatives to improve its communication strategy.

Among these is the provision of up-to-date information on prescription drugs through its new electronic drug labelling system and agreements with external partners to increase drug surveillance capabilities.

Its drug safety activities have been supported by a $10 million increase in funding from Congress.

In addition to the public meeting, the FDA is seeking additional feedback about risk communication through an Institute of Medicine study on the effectiveness of its drug safety system.

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