More FDA parlor game gossip -- this time from Jim Dickinson's FDA WebView:
The inside-the-beltway crowd are speculating that two potential candidates for FDA commissioner remain in the running — Baltimore health commissioner Joshua Sharfstein and Duke University clinical trial researcher Robert Califf. On Saturday, Sharfstein, who was at an Obama rally in Baltimore, dismissed the rumor of possibly being selected for the top FDA post, telling a radio interviewer that he expects to continue as the city’s health commissioner. If so, this leaves Califf as the potential front runner. He’s no stranger to the agency and currently works with several top officials under the critical path initiative to help modernize clinical trials. The FDA/Duke co-founded Clinical Trials Transformation Initiative seeks to improve clinical trial quality and efficiency. It was formed in response to growing frustration among patients, consumers, the academic community, and industry over the difficulty of conducting high-quality clinical trials in a timely manner to produce information physicians need to define optimal patient treatments. During the firestorm after Merck withdrew Vioxx in 2004, Califf joined critics on NBC’s Today Show who questioned whether FDA should have acted sooner in requesting post-marketing safety data on the drug. At the time, Califf suggested Vioxx’s withdrawal illustrated certain regulatory shortcomings. He said “rules need to change” and FDA should require large outcome trials for drugs used to treat chronic conditions. Additionally, Califf has publicly said that the agency is starved for resources and needs a "nonpolitical scientific base for what it does,” and without these “we are going to see more catastrophes along the lines of what we saw in the past with thalidomide and even going back to the origins of the FDA, ‘the horse named Jim,’ whose illness at the time that tetanus toxin was being made led to the deaths of some children. They really got the FDA started. I think we're going to see some pretty major catastrophes if we don't repair the problem.” Califf has served on FDA’s Cardiorenal Advisory Panel and the Institute of Medicine’s (IoM) Pharmaceutical Roundtable. He served on IoM committees that recommended Medicare coverage of clinical trials as well as the removal of ephedra from the market, and its Committee on Identifying and Preventing Medication Errors. He is currently a member of the IoM Forum in Drug Discovery, Development, and Translation, and FDA’s Science Board.
The inside-the-beltway crowd are speculating that two potential candidates for FDA commissioner remain in the running — Baltimore health commissioner Joshua Sharfstein and Duke University clinical trial researcher Robert Califf. On Saturday, Sharfstein, who was at an Obama rally in Baltimore, dismissed the rumor of possibly being selected for the top FDA post, telling a radio interviewer that he expects to continue as the city’s health commissioner. If so, this leaves Califf as the potential front runner. He’s no stranger to the agency and currently works with several top officials under the critical path initiative to help modernize clinical trials. The FDA/Duke co-founded Clinical Trials Transformation Initiative seeks to improve clinical trial quality and efficiency. It was formed in response to growing frustration among patients, consumers, the academic community, and industry over the difficulty of conducting high-quality clinical trials in a timely manner to produce information physicians need to define optimal patient treatments. During the firestorm after Merck withdrew Vioxx in 2004, Califf joined critics on NBC’s Today Show who questioned whether FDA should have acted sooner in requesting post-marketing safety data on the drug. At the time, Califf suggested Vioxx’s withdrawal illustrated certain regulatory shortcomings. He said “rules need to change” and FDA should require large outcome trials for drugs used to treat chronic conditions. Additionally, Califf has publicly said that the agency is starved for resources and needs a "nonpolitical scientific base for what it does,” and without these “we are going to see more catastrophes along the lines of what we saw in the past with thalidomide and even going back to the origins of the FDA, ‘the horse named Jim,’ whose illness at the time that tetanus toxin was being made led to the deaths of some children. They really got the FDA started. I think we're going to see some pretty major catastrophes if we don't repair the problem.” Califf has served on FDA’s Cardiorenal Advisory Panel and the Institute of Medicine’s (IoM) Pharmaceutical Roundtable. He served on IoM committees that recommended Medicare coverage of clinical trials as well as the removal of ephedra from the market, and its Committee on Identifying and Preventing Medication Errors. He is currently a member of the IoM Forum in Drug Discovery, Development, and Translation, and FDA’s Science Board.
