Three New OPDP Research Studies to Cover Broad Array of Promotional Activities

Oct. 22, 2018 – Broadcast disease awareness ads, accelerated approval disclosures in direct-to-consumer (DTC) ads, and physician interpretation of drug information in scientific publications as compared to promotional pieces are the subjects of future Office of Prescription Drug Promotion (OPDP) research, according to notices published Oct. 17 in the Federal Register.

“All three of these studies are interesting and demonstrate that the FDA is willing to push ahead with research that examines common activities of sponsors that may be misleading, both for doctors and patients,” said Coalition for Healthcare Communication Executive Director Jon Bigelow.

OPDP states in its notices that it has consistently conducted research that focuses on three main topic areas: (1) advertising features, including content and format; (2) target populations; and (3) research quality.

Comments on all three OPDP research studies are due by Dec. 17, 2018. Each of the new studies is outlined below.

Disease Awareness Ad Proximity Study

In taking a look at disease awareness ads and prescription drug promotion on television, which falls under the topics of advertising features and target populations, OPDP is interested in whether and to what extent the drug industry practice of releasing a disease awareness ad prior to releasing a new drug ad “may result in consumers confusing or otherwise misinterpreting the different information and claims presented” in both ads, the notice states.

OPDP cites earlier research showing that consumers “tend to conflate the information presented in prescription drug promotional materials with information presented in disease awareness communications. Specifically, the results of these studies suggest consumers incorrectly ascribe benefits to a prescription drug as a result of being exposed to information in a disease awareness communication that broadly describes the symptoms and negative consequences of the disease.”

The OPDP’s research on this topic will be divided into two parts. The first study will explore the impact on consumer perception and comprehension of different levels of temporal separation between the disease awareness communication and prescription drug promotion within a single period of television programming, as well as the level of similarity versus distinctiveness between these communication types. The second study will experimentally examine the impact of disease awareness communication temporal separation and exposure frequency on consumer perception and comprehension. For details on this research study, go to:

OPDP states that the results of the second study will examine the industry practice of “seeding the market” by running disease awareness ads in close proximity to product promotion ads. “The stated purpose of the FDA’s social science research is to inform guidance and policy. If the research finds that audience members conflate the two types of messages in their comprehension, FDA may well further regulate whether and how they may be used in proximity,” Bigelow explained.

For additional details on this research study, go to:

Accelerated Approval Disclosures Study

OPDP’s experimental study of accelerated approval disclosures “will examine the presence, wording, and prominence of a disclosure communicating information related to the drug’s accelerated approval in [DTC] promotional materials,” the notice states.

This study, which falls under the topic of advertising features (content and format), will examine whether it is appropriate for companies to share prescribing information (PI) – which includes complex concepts and sophisticated wording and is meant for healthcare professionals — in DTC promotional materials for drugs approved under accelerated approval.

To read more about the study design, go to:

Physician Interpretation Study

The OPDP research study entitled, “Physician Interpretation of Information About Prescription Drugs in Scientific Publication vs. Promotional Pieces” will examine “important public health issues in professionally directed prescription drug print promotion.”

Specifically, the study will “investigate how physician perception of prescription drug information is influenced by variations in informational context (presence of graphical elements and information delivery vehicle – medical journal abstract or sales aid), methodologic rigor of the underlying clinical study (high or low), and time pressure (present versus absent).”

OPDP cites prior research showing that physicians were less likely to prescribe the drugs or read the full study from trials funded by industry, and that physician prescribing behavior can be influenced by the context in which information is delivered.

To read more about this study, go to: