Life Science Compliance Update

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August 08, 2017

FDA Issues Two Proposed Studies on Disclosures for Advertising

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Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for oncology advertising. Both studies have comment periods that end on August 18, 2017.

For both proposals, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

General Advertising

The Food and Drug Administration Office of Prescription Drug Promotion (OPDP) plans to investigate the way repetition and over warning apply to the presentation of risks in promotional prescription drug print pieces. They propose to test two levels of the Important Safety Information (ISI) – short versus long – and the presence of the Brief Summary in two different medical conditions (overactive bladder and rheumatoid arthritis). This will be investigated in DTC print ads for prescription drugs.

OPDP will collect descriptive eye tracking data on adult participants' attention to the following: (1) The important safety information, (2) the brief summary, and (3) the indication and benefit claims.

OPDP will conduct one 60-minute pilot study with 40 participants and two 60-minute studies with 200 participants each (50 participants in each cell), for a total of 400 main study participants. The studies will be conducted in person in at least five different cities across the United States. The pilot study and main studies will have the same design and will follow the same procedure.

Participants who self-identify as having one of the medical conditions of interest will be randomly assigned to one of four test conditions. In Study 1, the ad will be for a fictitious drug to treat rheumatoid arthritis. In Study 2, the ad will be for a fictitious drug to treat overactive bladder. After obtaining consent, they will explain the study procedure to participants and calibrate the eye tracking device. To collect eye tracking data, an unobtrusive glasses-based real-world eye tracker with a minimum speed of 50 Hertz will be used. The test images will be presented on paper and sized similarly to how they would appear in print materials such as magazines. To simulate normal ad viewing, participants will view two ads. One of the ads will be the study ad. The non-study ad will be for a consumer product unrelated to health. Only eye tracking data from the study ad will be analyzed. Next, participants will complete a questionnaire that assesses risk perceptions, risk recall, efficacy perceptions, efficacy recall, and covariates such as demographics and health literacy. In the pilot study, participants will also answer questions as part of a debriefing interview to assess the study design and questionnaire.

Oncology Advertising

FDA is proposing to study the impact of disclosures as they relate to presentations of preliminary or descriptive scientific and clinical data in promotional labeling and advertising for oncology products. The use of disclosures is one method of communicating information to health care professionals about scientific and clinical data, the limitations of that data, and practical utility of that information for use in treatment. These disclosures may influence prescriber comprehension and decision making, and may affect how and what treatment they prescribe for their patients.

According to the FDA, promotional labeling and advertising for cancer drugs deserve specific attention. Oncology drugs represented 26 percent of the 649 compounds under clinical trial investigation from 2006 to 2011.

Different aspects of disclosures may influence their effectiveness. For example, despite the advanced education of health care providers, in a busy practice they may not be willing or able to process the disclosures thoroughly. The level of technicality in the disclosure may play a role in their use of the disclosure to contextualize the data display. Additionally, the addition of a general summary statement to frame the disclosure may help or hinder the processing of the disclosure and therefore the entire data display.

The proposed study seeks to address the following research questions:

  1. Do disclosures mitigate potentially misleading presentations of preliminary or descriptive data in oncology drug product promotion?
  2. Does the language (technical, non-technical) of the disclosure influence the effectiveness of the disclosure?
  3. Does the presence of a general statement about the clinical utility of the data in addition to a specific disclosure influence processing of claims and disclosures?
  4. Do PCPs, oncologists, and mid-level practitioners (nurse practitioners, physician assistants) differ in their processing of claims and disclosures about preliminary or descriptive data?
  5. Which disclosures do physicians prefer?

To address these questions, the FDA has designed a study that will be conducted in three independent phases, each phase examining a data display in a promotional piece for a unique oncological product. Independent variables will include: (1) Specific disclosure (technical, non-technical, none), (2) general statement (present, absent), and (3) specialty (oncologists, PCPs, mid-level practitioners). 

Outcome variables will focus on the assessment of the data display as well as attention to the disclosure, if present. Specifically, recognition of the clinical endpoint in the data display, comprehension of the data display, perceptions of the exploratory nature of the data, and the perceived credibility of the promotional piece will be examined.

Oncologists, PCPs, and non-oncology mid-level practitioners will be recruited to participate via the Internet, and the study is expected to take approximately 20 minutes. Participants will view professionally developed promotional pieces that mimic currently available promotion and answer questions. The questionnaire is available upon request.

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