As a part of the ongoing evaluation of FDA's regulations in this area, FDA is proposing to study the impact of disclosures as they relate to presentations of preliminary and/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. To address these questions, 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 oncology or hematology product. Independent variables will include: (1) Specific disclosure (technical, non-technical, none), (2) general statement (present, absent), and (3) specialty (PCPs, oncologists). Outcome (dependent) variables will focus on the assessment of the data display as a whole as well as attention to the disclosure, if present.
The latest form for Disclosures of Descriptive Presentation in Professional Oncology Prescription Drug Promotion expires 2021-12-31 and can be found here.
Supporting Statement B
Supporting Statement A
Approved with change
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Federal Enterprise Architecture: Health - Consumer Health and Safety