In 2007, the Pharmacists Planning Service, Inc. (PPSI) of San Rafael, California, submitted a petition to the FDA regarding concerns for readability and understanding of important medication information in DTCA. The PPSI states that "[t]hese ads ... are for prescription drugs and in many cases are promoting the prescription drugs but patients and consumers are not able to read them."
According to the 2007 petition, the PPSI petitioned the FDA regarding guidelines and regulations for the readability of DTCA in 1990. At the same time, California introduced legislation that required increased print size in DTCA for patients and consumers on nonprescription medication labels. In 1992, the Nonprescription Drug Manufacturers Association (NDMA) introduced guidelines which sought to regulate label readability of over-the-counter medications.
The 2007 petition requested that the FDA require increased print sizes on DTCA so that consumers and patients can easily read the information on such advertisements. Increasing print size may also require that the design of print ads be changed to improve layout and design, color, typography, column and line breaks, and text in boxes. The PPSI also requested that the FDA require companies to specifically dedicate special paragraphs to accurately and clearly represent drug interactions, adverse effects, FDA blackbox warnings, and other advice to patients.
In June 2013, the FDA responded to PPSI's 2007 petition and, although recognized PPSI's "valid points," denied its request to improve readability of DTCA. The FDA believes that its current regulations regarding DTCA are appropriate.
A positive step forward for California - the California senate has drafted legislation that would require prescription labels in 12-point, sans serif font. This would improve readability of prescription drug labels. This move has the potential to save lives and keep patients both safe and informed about the safe use of their prescription medications.
DTC Ads Say What? Check the Fine Print, If You Can Read It
See the 2007 PPSI petition to the FDA
See the FDA's reply to the 2007 PPSI petition