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DAA Expands Ad Privacy Controls to Mobile Marketplace

Feb. 26, 2015 – To “bolster both consumer trust and marketplace growth,” the Digital Advertising Alliance (DAA) yesterday launched two ... read more

Leveraging Technology and Other Highlights from DIA Marketing Meeting

Feb. 23, 2015 – Dale Cooke, owner of PhillyCooke Consulting, who spoke Feb. 18 at the Drug Information Association’s Marketing ... read more

FDA Budget Increase Relies on Higher User Fees

Feb. 16, 2015 – Although President Obama’s proposed budget for fiscal year 2016 includes increases for both the FDA and ... read more

Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ... read more

FDA Commissioner Hamburg to Leave FDA

Feb. 5, 2015 – After serving the FDA for six years, Commissioner of Food and Drugs Margaret Hamburg, M.D., will ... read more

21st Century Cures Discussion Draft Includes Textbook/Reprint Language, Communication Fixes

Jan. 29, 2015 – A 393-page discussion draft of legislation designed to accelerate the 21st Century Cures initiative – released ... read more

Transparency Proponents Slam Company-Provider Communication

Jan. 26, 2015 – Although biomedical companies can legally communicate and share information with physicians under the Physician Payments Sunshine ... read more

FDA Moves Forward with Major Statement Study, Responds to Coalition’s Comments

Jan. 14, 2015 – The FDA is taking the next step toward examining whether shorter, simpler risk disclosures in direct-to-consumer ... read more

Coalition: Issues to Watch in 2015

Jan. 13, 2015 — As 2015 gets fully underway, there are several issues that healthcare marketers should be following, according ... read more

Kamp to WSJ’s Pharmalot: CMS Move on CME “One of Biggest Flip Flops” Ever

Dec. 18, 2014 – This week’s release by the Centers for Medicare & Medicaid Services (CMS) of subregulatory guidance on ... read more

MM&M Tax Reform Prognosis: Stay Tuned

Dec. 4, 2014 — The looming threat of eliminating the marketing tax deduction as part of overall tax reform 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 tablet viagra 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.