FDA drug summaries: a simplification too far?BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h3135 (Published 12 June 2015) Cite this as: BMJ 2015;350:h3135
- Peter Doshi, associate editor, The BMJ
In the United States, where citizens are saturated with messages about drugs in the form of direct to consumer advertising, finding independent, plain English information takes great effort. Now, for the first time in its history, the US Food and Drug Administration (FDA) has entered this space.
The FDA began producing what it calls “drug trials snapshots” last November. “At its heart, this is an effort to be transparent,” according to John Whyte, director of professional affairs and stakeholder engagement, the FDA department leading the snapshots initiative.1 Snapshots are designed to provide the public with information about trial participants—numbers of men and women, and the breakdown of age and racial groups. Posted on the FDA website (www.fda.gov/drugtrialssnapshot), they highlight such demographic data in easy to read summaries alongside large color pie and bar charts and simple tables. Twenty two snapshots have so far been posted, but the FDA intends to publish snapshots for all new molecular entities and original biologics within 30 days of approval.2
Snapshots differ from traditional drug labels in both their target audience and their process of development. Whereas labels are written by manufacturers and approved by the FDA, snapshots are written entirely by the FDA. The information presented in snapshots is derived from the reviews of FDA medical, statistical, and other officers, who have arguably carried out the most careful independent analysis of the trials.
“We are not reinventing the wheel but rather lifting the veil on data that have always been there but may have been difficult to find. The draft goes through multiple levels of clearance, including the …