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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: September 8, 2005, Public Summary

The Food and Drug Administration’s (FDA) Drug Safety Oversight Board (DSOB or Board) held its third meeting on September 8, 2005, from 8:30 a.m. until 4:30 p.m.   

The primary focus of the meeting was to start a discussion of the factors to be considered when deciding whether to notify the public about an important emerging drug safety concern.  To assist the discussion, FDA staff briefed the Board on recent actions taken on emerging drug safety issues, including Adderall (amphetamine salts), and the Erectile Dysfunction Drugs – Cialis (tadalafil), Levitra (vardenafil), and Viagra (sildenafil citrate).  The Board members then discussed and commented on the examples and how one might generalize criteria from them to guide decisions for future emerging safety concerns. 

FDA staff also described for the Board the one action taken since the last Board meeting (July 27, 2005) on a significant emerging drug safety issue – the strengthened risk management program, called iPLEDGE, for Accutane (isotretinoin) and generic isotretinoin (see the recent Public Health Advisory)