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Kamp Commentary: Pricing Issues Take Center Stage in D.C.

May 23, 2017 — By Coalition for Healthcare Communication Executive Director John Kamp Participants at last week’s Coalition for Healthcare ... read more

Califf Calls for Off-label Promotion Code of Ethics

May 18, 2017 – At this week’s information-packed Coalition for Healthcare Communication’s Rising Leaders Conference, keynote speaker and former FDA ... read more

The Marketing Implications of Tax Reform

By John Kamp, Coalition for Healthcare Communication Executive Director May 11, 2017 – Although no one seems to like the ... read more

Gottlieb Vote Headed to Full Senate

May 1, 2017 – Having cleared the Senate Committee on Health, Education, Labor and Pensions (HELP) with a 14-9 vote ... read more

What Medical Marketers Can Expect from President Trump, Republican-led Congress

April 24, 2017 – There is no doubt that the Trump administration is likely to change health policy, but the ... read more

Kamp: Three Ways Congress Could Suppress DTC or All Medical Marketing

Coalition Commentary by Executive Director John Kamp April 17, 2017 — Agencies, media and clients all need to watch closely ... read more

States Make Moves to Ease, Restrict Medical Communications

March 31, 2017 – With Congress in a seemingly permanent state of gridlock, individual states are taking actions that may ... read more

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Drug Facts Literature Review: Call for Comments

Feb. 3, 2012 – There are just 10 days left to comment on an FDA draft report that explores the best way to present risk and benefit information in prescription drug ads.

The draft report, “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review,” which was made public at the end of 2011, attempts to provide insight regarding the value of quantitative data, how the presentation of the data influences patients’ and clinicians’ processing and understanding of risks and benefits, and whether a “Drug Facts” box on promotional labeling or print advertising would improve healthcare decisionmaking.

Three key literature review findings in the report – issued by RTI International on behalf of the FDA – are:

  • Numeric presentation of risk/benefit information appears to have had a positive impact on several outcomes relative to non-numeric presentation of risk/benefit information.
  • No specific, single format, structure or graphical approach emerged as consistently superior.
  • Numeracy and health literacy are variables that deserve more empirical attention, because results may vary for different people depending on their numeracy and literacy levels.

RTI notes in the report that there are important gaps in the current literature, such as a predominant focus in the literature on risk information alone versus studies of both risk and benefit information. However, the report states that evidence suggests “that using relatively simple presentations of numeric and non-numeric information appears to be important to prevent overwhelming viewers, regardless of the specific approach employed.”

The agency is accepting both electronic and written comments referencing on the literature review report (referencing Docket No. 2011-N-0813) by Feb. 13. The Coalition for Healthcare Communication is seeking input from the community to inform its comments, and also encourages industry entities to comment to the agency directly. To share your perspectives with the Coalition, please contact Coalition Executive Director John Kamp at jkamp@cohealthcom.org.