DSOB MEETING SUMMARY ISSUED

FDA officials briefed members of the Drug Safety Oversight Board (DSOB) about safety activities in the Office of Drug Safety and the role of drug safety in the Office of New Drugs during the DSOB's second meeting last month.

In addition, DSOB members were informed of actions taken since the board's previous meeting June 17, specifically on measures taken with the Fenatanyl Transdermal Patch and Palladone (hydromorphone HCl), according to a summary of the meeting. Board members discussed and commented on the actions, remarking on the safe use of opiods in complex drug systems in particular.

DSOB members also discussed recent web postings on emerging drug safety issues including antidepressants, such as Celexa (citalopram), Wellbutrin (bupropion), the Fentanyl Transdermal Patch, Iressa (gefitinib), and Mifeprex (mifepristone).

The DSOB was unveiled in February as part of a larger reform effort to improve oversight and openness at the FDA. Some critics have claimed the board's closed meetings violate the spirit of the agency's initiative. The FDA has said the meetings are not open to the public due to the proprietary nature of the discussions.

For more information on the meeting, access http://www.fda.gov/bbs/topics/NEWS/2005/NEW01217.html (http://www.fda.gov/bbs/topics/NEWS/2005/NEW01217.html).