June 20, 2017 – The FDA’s Office of Prescription Drug Promotion (OPDP) announced in the Federal Register last week that it would be conducting research on the ability and willingness of low- to non-Internet users to access direct-to-consumer (DTC) broadcast ad references to “adequate provision” of package labeling via a 1-800 number or print ad components. The agency also will embed in the survey an assessment of the “opening statement” language used to introduce risks.

The requirement for adequate provision “is generally fulfilled when a firm gives consumers the option of obtaining FDA-required labeling or other information via a toll-free telephone number, though print advertisements or product brochures, through information disseminated at health care provider offices or pharmacies, and through the Internet,” the June 12 notice (OPDP Study) states, with the purpose of these various access points “to ensure that most of a potentially diverse audience can access the information.”

At this juncture, the OPDP will survey older adults and those individuals with low education and income levels to address concerns that a Web site alone may not adequately serve all potential audiences. “The 1-800 number and print ad may provide special value to consumers who are low- to non-Internet users and/or those who value privacy when conducting initial research on a medication.” The study also will assess whether this audience would make use of Internet options if other options were unavailable.

Additionally the agency will embed experimental manipulations into the survey “as an exploratory test to assess the impact of opening statements that could be used to introduce risks in DTC prescription drug ads.” The three opening statements that will be evaluated include:

• “[Drug] can cause severe, life-threatening reactions. These include …”
• “[Drug] can cause serious reactions. These include …”
• “[Drug] can cause reactions. These include …”

All risk statements will conclude with the following language: “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.” Participants will be randomly assigned to experimental condition, and all manipulations will be pre-recorded to allow for consistent administration, according to OPDP. Following exposure to these manipulations, “participants will respond to several questions designed to assess risk perceptions.”

The FDA will accept comments on the information collection aspects of this survey until Aug. 11.