Public Citizen’s Sidney Wolfe Joins FDA Advisory Committee

October 31, 2008

By Kurt R. Karst –      

Happy Halloween!  Earlier this week, Health News Daily reported that Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, was named a permanent member of FDA’s Drug Safety and Risk Management Advisory Committee.  A copy of Dr. Wolfe’s  Curriculum Vitae is available here

Throughout his 36-year tenure as Public Citizen’s Health Research Group Director, Dr. Wolfe has repeatedly challenged pharmaceutical companies and FDA regarding drug and other product issues.  For example, earlier this year, Public Citizen sued FDA for failing to respond to a 2006 citizen petition seeking the removal of propoxyphene drug products from the market.  And just yesterday, Public Citizen submitted a citizen petition to FDA requesting that the Agency immediately ban the diabetes drug AVANDIA (rosiglitazone).

So how will Dr. Wolfe affect FDA’s Drug Safety and Risk Management Advisory Committee as a permanent member?  Well, one might only need to look at his recent participation as a temporary voting member at a May 6, 2008 joint meeting of FDA’s Drug Safety and Anesthetic and Life Support Drugs Advisory Committees concerning FENTORA (fentanyl buccal tablet).  During the meeting, Dr. Wolfe reportedly played a significant role in setting the tone that led the committees to vote against approving FENTORA for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions.  Folks will get to see Dr. Wolfe in action as a permanent advisory committee member when the Drug Safety and Risk Management Advisory Committee meets later this year (in November and December).

Categories: Drug Development