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# FDA Probes DTC Promotional Claims ‘Tradeoffs’
- URL: https://www.fdaweb.com/fda-probes-dtc-promotional-claims-tradeoffs/
- Published: 2022-04-25T12:00:00.000Z
- Updated: 2026-09-14T17:42:00.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5151668

CDER’s Office of Prescription Drug Promotion (OPDP) is seeking comments on a research proposal to understand the “Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion.”

The research is intended to examine the “relative importance of prescription drug product information such as prescription drug efficacy, risk, adherence, and patient preference claims in two medical conditions (Type 2 diabetes and psoriasis) in consumer and physician samples,” an [FDA notice](https://www.govinfo.gov/content/pkg/FR-2022-04-25/pdf/2022-08728.pdf?ref=fdaweb.com) explains. “When confronted with an important decision, people tend to make choices that reflect a series of tradeoffs between certain desirable and undesirable attributes of a product, service, or experience.”

OPDP says treatment decisions are influenced by a drug’s impact on quality of life, complexity of dosage regimens, mode of administration, cost, and marketing claims unrelated to medicinal properties. “Although diagnosed consumers may weigh the risks, benefits, or other salient characteristics of prescription drug products differently than physicians, little research directly compares the treatment preferences of these two groups…,” it says. “Understanding the tradeoffs among drug product characteristics diagnosed consumers make — and how the tradeoffs could potentially differ from the tradeoffs made by physicians — will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions.”

OPDP says it will use data from the study to “draw inferences about the relative value they place on different product attributes, estimate the relative importance of different attributes, explore the tradeoffs that consumers and physicians are willing to make to avoid or accept specific attribute levels, and compare the preferences of these two groups.” The target sample size for the main study is 800 physicians and 800 consumers, which will be split across each cohort focusing on treatments for psoriasis and the other half focusing on treatments for Type 2 diabetes.