FDA not utilizing its advisory system

Share this article:
Public Citizen says an analysis of FDA advisory committee meetings between January 1997 and last July found the agency is making suboptimum use of its advisory committee system. Writing in the December 23 issue of Lancet, Public Citizen said a declining minority of products up for approval face advisory committees, the FDA frequently elects not to present its own interpretations of sponsors' data, and the rate of inconsistency between advisory committee recommendations and subsequent FDA actions is higher (28%) than generally assumed, even though the follow-up period studied is so short that few additional data could have been generated in the interim.

Public Citizen said that 35 of 147 new molecular entities approved between 2000 and last July were preceded by advisory committee meetings. That represented a decrease from 1998 and 1999 when 40% and 52% respectively of approved NMEs were preceded by advisory committee meetings. NMEs with priority reviews were twice as likely to be preceded by an advisory committee meeting as were NMEs approved through standard review.

For the study period, the FDA did not make an oral scientific presentation at 18% (49 of 275) of drug advisory committee meetings, but there was no trend over time.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.