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Substantial Evidence and Other Standards of Evidence in Promotion
Session Chair(s)
Glenn N. Byrd, MBA
President
GByrd Ad-Promo Solutions, LLC, United States
The panel will discuss the quality/type of data needed to support various claims in prescription drug promotion. The quality/type of data that are required depends upon the type of claims one is seeking, such as treatment benefit claims (e.g., clinical outcomes, patient-reported outcomes) and non-clinical claims (e.g., convenience, ease of use), to cite a few. This area is a source of frequent discussion between companies’ regulatory/legal reviewers and marketing teams. It is also a topic frequently cited by FDA in its enforcement actions. This session will explore the meaning of terms such as: substantial evidence, substantial clinical experience, adequate evidence, etc.; and examine related enforcement actions.
Speaker(s)
Panelists
Elaine Hu Cunningham, PharmD
FDA, United States
Sr. Regulatory Review Officer, OPDP, CDER
Panelists
Mark S Hirsch, MD
FDA, United States
Medical Team Leader, Div. Reproductive & Urologic Drug Products
Panelists
James P. Stansbury, PhD, MPH
FDA, United States
Social Science Analyst, Division of Non-Prescription Clinical Evaluation, CDER
Panelists
Eugene J Sullivan, MD
EJS Consulting, LLC, United States
Principal
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