At last week's joint meeting of the Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management advisory committees on Avandia rosiglitazone, the returning panel members had more confidence in the drug's safety after they reviewed readjudicated data from the RECORD trial than they did at a 2010 meeting. The three returning panel members who voted to withdraw the drug in 2010 all voted to keep Avandia on the market at last week's meeting, with two of the three voting to relax the REMS requirements and the third voting to keep the REMS as is. Among the four previous panel members who requested a REMS, one voted to remove the REMS and three voted to ease it. Most other panel members who voted for only label changes in 2010 were reassured by the reanalysis of RECORD and voted to ease or remove the REMS restrictions this time around. Sixteen of the 26 panel members at last week's meeting were present at the 2010 meeting.

Member

Position

Jul-10

Jun-13

Proschan, Michael

Mathematical statistician, biostatistics branch, National Institute of Allergy and Infectious Diseases (NIAID) at NIH

Abstained

Remove REMS

Day, Ruth

Dir, medical cognition laboratory, Duke U

Continued marketing, REMS/label changes

Modify REMS

Hammerschmidt, Dale

Prof of medicine, due diligence officer, U of Minnesota

Continued marketing, REMS/label changes

Modify REMS

Killion, Rebecca

Patient representative

Continued marketing, REMS/label changes

Remove REMS

Morrato, Elaine

Asst prof, dept of health systems, management and policy, Anschutz Medical Campus, U of Colorado-Denver

Continued marketing, REMS/label changes

Modify REMS

Burman, Kenneth (acting chair)

Chief of endocrine section, Washington Hospital Ctr

Continued marketing, label changes

Modify REMS

Flegal, Katherine

Senior research scientist and distinguished consultant, National Ctr for Health Statistics, CDC

Continued marketing, label changes

Modify REMS

Geller, Nancy

Dir, office of biostatistics research, National Heart, Lung and Blood Institute (NHLBI) at NIH

Continued marketing, label changes

Modify REMS

Kaul, Sanjay

Dir, fellowship training program in cardiovascular diseases, Cedars-Sinai Heart Inst; prof, David Geffen School of Medicine at UCLA

Continued marketing, label changes

Modify REMS

Oakes, David

Prof, dept of biostatistics and computational biology, U of Rochester

Continued marketing, label changes

Remove REMS

van Belle, Gerald

Dir, clinical trials ctr, resuscitation outcome consortium; prof, depts of biostatistics and environmental and occupational health sciences, U of Washington

Continued marketing, label changes

No REMS/label changes

Felner, Eric

Assoc prof of pediatrics, Emory U School of Medicine; dir, pediatric endocrine fellowship program, Emory-Children's Ctr

Continued marketing, no REMS/label changes

No REMS/label changes

Moss, Arthur

Prof, dept of medicine, cardiology, U of Rochester School of Medicine

Continued marketing, no REMS/label changes

Modify REMS

Heckbert, Susan

Prof of epidemiology, U of Washington, Cardiovascular Health Research Unit

Withdraw

No REMS/label changes

Konstam, Marvin

Chief physician executive, cardiovascular ctr, Tufts Medical Ctr; prof of medicine, Tufts U School of Medicine

Withdraw

Modify REMS

Woods, T. Mark

Clinical coordinator and residency program dir, pharmacy dept, St. Luke's Hospital

Withdraw

Modify REMS