Unger Takes Over ODE I As Acting Director; Temple To Focus On Clinical Science Role
This article was originally published in The Pink Sheet Daily
Ellis Unger has been promoted to run the CDER Office of Drug Evaluation I, although he will retain the acting title like his predecessor.
Long-time ODE I Acting Director Robert Temple, considered among FDA’s most experienced and respected regulators, will scale back his duties as part of the change. He will continue as acting deputy director of ODE I, but likely would be less involved in the day-to-day activities of drug review.
Center for Drug Evaluation and Research Director Janet Woodcock said in an internal memo released Jan. 30 that she asked Temple, who has had a lengthy and much-lauded career at FDA, to give up the ODE I director position to devote more time to his position as Deputy Center Director for Clinical Science.
Woodcock said in the memo Temple “plans to maintain substantial (but somewhat less) involvement in ODE I activities.”
His role as deputy center director for clinical science role was created in November 2009 as part of a reorganization that elevated him from director of the Office of Medical Policy (Also see "FDA's Temple Changes Roles As Part Of CDER Shuffle" - Pink Sheet, 13 Nov, 2009.). In the broader role, Temple is in charge of “high-level initiatives and programs related to clinical science and clinical trial methodology,” according to the memo. It touches a broad range of activities throughout CDER and is intended to increase the consistency of center operations.
Temple has been involved in some of the agency’s most high-profile projects, and remains outspoken. Recently he commented that the agency’s growing Sentinel database could become a comparator control for safety issues the agency investigates, rather than a way to detect new safety signals (Also see "FDA’s Temple Sees Sentinel As Important Tool For Confirming And Analyzing Drug Adverse Events" - Pink Sheet, 23 Jan, 2012.).
He has also frequently spoken out about potential improvements in clinical trial design or other ways to improve drug development. For instance, Temple has encouraged rare disease groups to learn their conditions’ natural histories, which can lead to faster drug development (Also see "Rare Diseases Need Ongoing Natural History Studies To Speed Trials, FDA Says" - Pink Sheet, 14 Nov, 2011.).
Unger Not Shy
Unger had been deputy director of ODE I since August 2008 and has been with CDER since 2004. His position has had him involved in many of the major drug applications to come through FDA in the last couple years, including the novel anticoagulant drug reviews, such as Boehringer Ingelheim GMBH‘s Pradaxa (dabigatran).
FDA approved the 150 mg strength of the antithrombotic, but not the 110 mg dose. Unger was skeptical that prescriber education would change medical practice and could result in inappropriate use of the smaller dose (Also see "Pradaxa Review Shows FDA Doubts About The Power Of REMS To Change Prescribing Practices" - Pink Sheet, 1 Apr, 2011.).
He has not shied away from controversy. During a July 2010 advisory committee meeting about the safety of GlaxoSmithKline Inc.’s diabetes drug Avandia from the market, Unger rhetorically asked whether GSK could be trusted to tell the truth about its RECORD trial. He also criticized cardiology reviewer Thomas Marciniak’s post-hoc re-adjudication of adverse events in the RECORD trial as inappropriate.
Unger concluded the study did not show an increased impact on mortality. Rosiglitazone was kept on the market, although with distribution restrictions expected to limit its use (Also see "FDA, EMA Decisions On Avandia Reflect The Power Of REMS" - Pink Sheet, 27 Sep, 2010.).
The dispute between Unger and Marciniak was viewed as indicative of the internal struggles FDA staff had when making a decision about the drug (Also see "FDA's Marciniak vs. Unger: Cardio Experts Divided On GSK's RECORD Study" - Pink Sheet, 19 Jul, 2010.).