Biotech Values

[DewDiligence]

How tough are FDA advisory committees?
Keep reading for some hard data.

http://blogs.wsj.com/health/2010/06/16/which-fda-advisory-committee-is-the-toughest

›June 16, 2010, 3:07 PM ET
By Katherine Hobson

While the recommendations of the FDA’s advisory committees aren’t binding, the agency usually follows their advice. So the track records of those committees, analyzed in a new research note from Concept Capital’s Washington Research Group, are of interest.

The headline number is that between 2007 and 2010, 70% of all applications for new therapies or major new uses for already-approved products got positive recommendations.

But the thumbs-up rate ranges from 55% (12 of 22 drugs) for the oncologic drugs committee [ODAC] all the way up to 100% (7 of 7 drugs) for the peripheral and central nervous system drug advisory committee (which most recently recommended approval of Novartis’s MS drug Gilenia).

Obviously, the fewer drugs a committee considers the more weight each decision is accorded in the batting average. Committees advising on anti-viral (80% positive recommendations, rejecting only AstraZeneca’s motavizumab), gastrointestinal (60%), and reproductive health (60%) drugs each saw only five candidates in those four years.

In other popular drug categories, the advisory committee for cardio-renal drugs considered 13 therapies and made positive recommendations on 8 of them [62%], while the psychopharmacologic committee gave the thumbs-up to 11 of 12 [92%].

The advisory committee for endocrinologic and metabolic drugs — including diabetes and anti-obesity therapies — has approved 7 of the 8 drugs considered in the past four years. It’s going to be busy going forward, given the three anti-obesity drugs submitted to the FDA for consideration [those from ARNA, VVUS, and OREX].

In some cases a single product was being considered for more than one indication; each of those counted separately in the calculations.‹