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U.S. Department of Health and Human Services

About FDA

Evaluation of Standardized Risk Benefit Information

Description: Determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format to promotional labeling or print advertising would improve healthcare decision making by clinicians, patients, and consumers.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Submit first progress report to Congress

3/31/2011

Completed 3/23/2011

B. Receive draft literature review summarizing the scientific evidence and research on decision making and social and cognitive psychology

8/1/2011

Completed 8/1/2011

C. Present results of the literature review to the FDA Risk Communications Advisory Committee for their review and recommendations

11/17/2011

Completed 11/17/2011

D. Complete quantitative research study of the value of adding quantitative information to direct-to-consumer (DTC) print and television advertisements

8/30/2011

(11/1/2011)

(6/15/2012)

Completed 3/30/2012

E. Complete display page research study of how physicians and consumers make risk benefit assessments and how consumers make such assessments in response to variations in the display page of DTC print ads

3/1/2012

(6/1/2012)

(9/1/2012)

(3/1/2013)

(6/28/2013)

Completed 4/29/2013

F. Complete format research study of the type of information that could be presented in a standardized "box" and how qualitative information might be included

9/1/2012

(4/1/2013)

(6/28/2013)

Completed 6/26/2013

G. Submit second progress report to Congress

3/31/2012

Completed 6/4/2012

H. Submit third progress report to Congress

3/31/2013

(6/4/2013)

Completed 6/4/2013

I. Submit final report to Congress

9/30/2013

(Fall-Winter 2013)

(Spring 2014)

On Track

Footnotes

  • (1) As research progresses, approaches and strategies can change including the milestones listed under each project. In instances where research approaches and strategies change and milestones and dates are affected, the revised milestone date will be provided in italics under the original milestone date.
  • (2) Research timelines are dependent on timing of OMB approval of data collection instruments.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.