Quoted from http://therpmreport.com/Free/53e26947-9400-47f5-8d03-3dc9d3430668.aspx
IoM Will Address Ethics in Safety Studies Prior To Avandia Advisory Committees
By Cole Werble
The RPM Report
Monday, May 24 2010
FDA is acting promptly to create political and scientific cover for the second public review of Avandia safety issues in mid-July. A former top staffer to House Energy & Commerce Chairman Waxman is doing an internal study of agency post-marketing safety procedures to assure Capitol Hill that FDA takes the issue seriously; an IoM workshop is convening in early June to prepare a preliminary review on the ethical issues with post-market safety studies.
The Food & Drug Administration is likely to have a preliminary outside assessment of ethical issues surrounding post-marketing safety studies in time for an expected July 13 advisory committee focused on the safety profile of GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone).
The Institute of Medicine is holding a half-day meeting on June 7 to collect information for a preliminary “letter report” due in July – presumably in time for the July 13 joint meeting of Endocrinologic & Metabolic Drugs Advisory Committee and Drug Safety & Risk Management Advisory Committee.
The official agenda for the July combined meetings has not yet been issued, but FDA has promised Congress to take up the status of the GlaxoSmithKline post-marketing trials to determine the extent of adverse cardiovascular outcomes and mortality with use of rosiglitazone at that meeting.
At the request of FDA Commissioner Margaret Hamburg, IoM has assembled a 12-member committee with a heavy emphasis on work in bioethics and epidemiology to address the ethical issues around post-market studies of products that are suspected of having safety issues.
Hamburg asked IoM to put together the committee in late March after Sen. Charles Grassley (R-Iowa) released a report showing that some FDA staff questioned whether an ongoing Avandia post-marketing safety study is ethical. Hamburg noted the request for the IoM review in her March 30 response to Grassley.