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 on this drug at
http://www.fda.gov/cder/drug/infopage/accutane/default.htm)
DSOB Meeting Summaries
Date created: September 22, 2005 |