The dynamic of CDERs Medical Policy Council is a critical puzzle for AMRN--my thanks to BB for his splendid enlightenment on the MPC thus far. As he notes the Chair of the Council looks favorable with the December 2013 departure of Rachel Sherman. But despite some postings about her leaving in disgrace, I can find nothing but evidence of a normal end-of-calendar year retirement with 25 years of pension eligible service. She was a long-time protege of Woodcock and when Janet announced she was staying as CDER director, Sherman who headed many succession lists for next director, probably figured she'd cash in--which she no doubt did as a Principal at Greeleaf Health. The "acting" chair, PHS Capt Denise Hinton, won't be a heavy like Sherman, but her longtime oversight of the Drug Marketing Division will make her sensitive to the regulatory mess of "fish oil" claims and related free speech issues. The power the the Council--especially on the AMRN case--swings to the two cardio heavies Jenkins and Temple. Del Pan as the head epi guy will also help provide a much better data perspective than the ADCOM fiasco. If Jenkins is pitching his own issue to the Council (and thus preparing the briefing document), this could be a two-man fast break for the length of the court ending in a slam dunk as the cardio community that Jenkins & Temple know better than anyone would certainly value outcome answers to CVR.
It would help reading the tea leaves if we knew names of the ExecSec of the Council and the two one-year-term-limit MD's (a review division director and a reviewing MO). Thankfully it doesn't look as tho Mary Parks new title makes her eligible, but it is a little disconcerting that she was promoted from Director of DMEP to Dep Director of ODE II in May 2013. If she's somebody's protoege, we may have a problem with her new supervisory perch over DMEP and its ADCOM legacy. Anyone with more insights--or even documented dirt! Thanks again BB--keep up the good work.
