The Role of Social Science in Prescription Drug Promotion at FDA and Preview of Upcoming

Studies Kathryn J. Aikin, Ph.D.

Senior Social Science Analyst, Research Team Lead Office of Prescription Drug Promotion | CDER | FDA

DIA Advertising and Promotion Regulatory Affairs Conference

Marriott Hotel and Conference Center| N. Bethesda, MD

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Office of Prescription Drug Promotion’s (OPDP) Mission

• Protect the public health by helping to ensure that prescription drug information is truthful, balanced, and accurately communicated

• Guard against false or misleading advertising and promotion through comprehensive surveillance, enforcement, and educational programs

• Foster better communication of information to help patients and healthcare providers make informed decisions about treatment options

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Organizational Structure

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Office of the Commissioner

Center for Food

Safety & Applied Nutrition

Center for Drug

Evaluation & Research

Center for Biologics

Evaluation & Research

Center for Devices &

Radiological Health

Center for Veterinary Medicine

National Center for Toxicological Research

FDA Organization

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Office of Regulatory

Affairs

Center for Tobacco Products

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Catherine Gray Supervisor

Advertising and Promotion Policy Staff

Mark Askine Deputy Office Director

Thomas Abrams Director

Robert Dean Director

Division of Advertising and Promotion Review II

Andrew Haffer Director

Division of Advertising and Promotion Review I

OPDP Organizational Structure

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Catherine Gray Supervisor

Katie David (Acting) Deputy

Supervisor

Julie Chronis Regulatory Counsel

Olga Salis Project Manager

Vacant Regulatory Counsel

Kemi Asante Policy Analyst

Helen Sullivan Social Science Analyst

Lauren Miller Regulatory Counsel

Kathryn Aikin Team Lead

Research Team

Kevin Betts Social Science Analyst

Becki Vogt Project Manager

Sheila Ryan Team Lead Policy Team

Amie O’Donoghue Social Science Analyst

Michael Wade Project Manager

Diane Nhu Project Manager

Jason Cober Team Lead

Project Management Team

Robyn Tyler Team Lead

Regulatory Counsel Team

Dominic Cirincione Regulatory Counsel

OPDP/Advertising and Promotion Policy Staff

Sabrina Smith Administrative Officer

(serving OPDP via OMP)

Elizabeth Pepinsky Policy Analyst

Christine Corser Policy Analyst

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OPDP Research Team

• Kathryn Aikin, Ph.D. (Team Lead) • Kevin Betts, Ph.D. • Amie O’Donoghue, Ph.D. • Helen Sullivan, Ph.D., M.P.H.

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How Social Science Can Inform Approach to Problems

• Help identify goals

• Identify barriers to achieving goals ‒ Cognitive barriers (capacity, motivation, attention) ‒ Behavioral barriers (time, opportunity) ‒ Others (literacy)

• Identify potential solutions

• Test and verify effectiveness of solutions

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Role of Research Team What we do

• Provide scientific evidence and advice to help ensure that OPDP’s policies related to prescription drug promotion have the greatest benefit to public health – Investigate issues relevant to healthcare professional

and patient/consumer usage of medical product information

– Consider the audience’s perception and comprehension of medical product information

– Assess the accuracy and effectiveness of the informational messages

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Role of Research Team (cont.) How we do it

• Apply social science and communication principles to OPDP’s: – Advice to industry, academia or internal FDA

stakeholders – Guidance and policy development – Research – Surveillance and compliance activities

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OPDP’s Research Agenda

• Provide science-based evidence and perspective • Studies are proposed and selected to fulfill a

number of purposes such as: – Congressional mandate – Help inform guidance and policy development – Enhance scientific literature base

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Application of Social Science Principles to Research

• Advertising Features ‒ Content ‒ Format

• Target Population(s) • Research Quality

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Focus of OPDP’s Research Studies

• Advertising Features – How do the features of the promotion impact the

communication and understanding of prescription drug product risks and benefits?

– Examples include: • Quantitative Information • Advertising and message elements • Disease characteristics • Product characteristics • Other elements, such as cost or comparative information

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Focus of OPDP’s Research Studies (cont.)

• Target Population

– How does understanding of prescription drug product risks and benefits vary as a function of audience?

– Variables include: • Literacy • Education • Age

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Focus of OPDP’s Research Studies (cont.)

• Research Quality

– How can the quality of the research data be maximized to ensure the best possible return on investment for FDA?

– Variables include: • Analytical methodology development • Sampling and response issues

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Research Design Choices

• Surveys – Survey of opinions of DTC promotion

• Experimental research – Studies that employ random assignment to

condition in order to test causative hypotheses

• Qualitative research for development purposes – Smaller studies designed to efficiently focus future

research priorities and considerations

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Accelerated Approval Disclosure Adequate Provision Adolescent DTC Ads Animation in DTC Attentional Effects Brief Summary Claim ID Comparative Composite Corrective Disclosures Disease Awareness 1 Disease Awareness 2 Display Page (Consumer) Display Page (HCP) DTC Survey 2 Format Study Focus Groups on Targeted and Natural Framing Risks Pilot Frequency of Ad Exposure HCP Survey 1 HCP Survey 2 HCP Interviews 1 HCP Interviews 2 HCP Risk Processing Hearing and Older Adults Limited Space Market Share Claims in DTC Major Statement Content Analysis Mobile Content Analysis Oncology Disclosure Oncology Online Content Analysis Online Studies Price Comparison Quant TV Study Risk Amount and Location in DTC Risk in Each Part HCP Scale Development Source Study Standardized Risk Statement DTC Supers

Content

Format

Target Populations

Research Quality

Advertising Features

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Public Comment Periods for OPDP Social Science Research

• Two statutory comment periods • 60-day Federal Register Notice

– Comments to FDA

• 30-day Federal Register Notice – Comments to OMB

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Sneak Peek at Upcoming Research

• Focus groups • Surveys • Experimental studies

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Interpretation of Claims in Scientific Publications vs. Promotional Pieces

• Subject matter: Investigate the impact of information context, information quality, and presentation of FDA approval status in healthcare professional prescription drug promotion.

• Description: – Three types of context (medical journal, sales aid without graphic

design elements, sales aid with graphic design elements) – Two types of study quality (classified as high or low) – Presence of a sentence saying the product is approved by FDA

(present, absent). • We will test promotional (sales aid) and non-promotional

(journal) sources to examine the potential differences in perception that may arise by presenting the same information in different contexts.

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Disease Awareness and Product Promotion in DTC Television Ad Contexts

• Subject matter: Test the effects of similarity, positioning, and timing of disease awareness ads on consumer perception and understanding of direct-to-consumer (DTC) product ads.

• Description: In two studies, we will examine the impact of – – Perceptual similarity between target ads (disease

awareness and product promotion) – Distance between target ads over the course of

programming – Exposure frequency and delay.

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Healthcare Professional Survey of Prescription Drug Promotion

• Subject matter: Healthcare professional promotion of prescription drugs

• Description: A nationally representative sample of HCPs will be recruited online to answer questions about their opinions, attitudes, beliefs, and intentions regarding pharmaceutical promotion directed at them.

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Focus Groups Examining Accelerated Approval Information

• Subject matter: Consumer understanding of information about the accelerated approval process.

• Description: – Eight focus groups – Focus group moderator will explain the accelerated

approval process to participants and ask for their perceptions and reactions.

– Focus groups will explore the types of information participants would like to have when making decisions about prescription drugs. www.fda.gov

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Experimental Study of an Accelerated Approval Disclosure

• Subject matter: Examine utility and consumer comprehensibility of a disclosure explaining the drug's accelerated approval

• Description: – Participants will view a website for a fictional oncology

prescription drug and then complete a questionnaire that assesses their attention to and understanding of the product’s accelerated approval information.

– Websites will vary the presence, prominence, and readability of an accelerated approval disclosure.

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Healthcare Professional Interviews: Risk Processing for Newly Promoted

Drugs • Subject matter: Healthcare professional promotion

of prescription drugs

• Description: – Study how HCPs process risk information for newly

promoted prescription drug products, including any impact of typical time constraints.

– The research methodology will involve in-person, semi-structured interviews with practicing HCPs.

– The study will assess attention to risk information in a mock promotional piece using eye-tracking technology.

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Additional Information About OPDP Research

OPDP Research Website • Completed projects

– Link to publication

• Research in progress – Link to 60day FRN, 30day FRN

• https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm

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