June 28, 2013 – The Food and Drug Administration (FDA) recently denied a 2009 petition from the Pharmacists Planning Service Inc. (PPSI) requesting that the FDA “standardize and increase print size for direct-to-consumer [DTC] advertising for readability of patients and consumers,” particularly the elderly.

In a June 10 letter to the petitioner, Center for Drug Evaluation and Research Director Dr. Janet Woodcock stated that although the agency believes that PPSI raises “valid points about the importance of readability of the brief summary in prescription drug DTC advertisements,” it has “determined that it is not necessary or appropriate to revise our regulations at this time.”

In support of this position, Woodcock cited FDA regulations that take into account “all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space and any other techniques apt to receive emphasis.” These regulations “require manufacturers to present risk information … with a prominence and readability reasonably comparable to the claims of effectiveness,” the letter states.  

Woodcock also mentioned that draft guidance documents regarding the presentation and format of risk information (May 2009) and the brief summary in DTC ads (January 2004) – when finalized – “will represent FDA’s current thinking on the topics they cover.”  In sum, she stated that the regulations, draft guidances and the availability of comment and advice from FDA “provide sufficient and appropriate direction and flexibility for manufacturers to prepare DTC prescription drug brief summary materials that are readable and legible.”

“The FDA rightfully rejected this petition because it focuses on the wrong issues and proposes changes that do not go to the root of the problem,” according to Coalition for Healthcare Communication Executive Director John Kamp. He asserted that a more significant issue with DTC ads may stem from applying 50-year-old drug advertising regulations to both healthcare professionals and consumers.

“The existing fine print in drug advertising must be reviewed and revised by the FDA, but the size of the print is not the problem,” Kamp said. “The needs of prescribing doctors and their patients are widely divergent, requiring a new set of rules addressing the different audiences as well as cultural and media differences of our time.” Still, he continued, “the time is right to review the rules and make all drug ads shorter and better focused on the needs of patients.”

The PPSI told Pharmalot that it will continue to fight for the patients that have difficulty reading the fine print in DTC ads, and that it is supporting efforts in California to pass legislation that would require pharmacists to print certain information in a specific size and font (to read more, go to: http://www.pharmalive.com/dtc-ads-say-what-check-the-fine-print-if-you-can-read-it).