The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products
Kerri-Anne Mallet, MBA
Vice President, Clinical and Regulatory Affairs
Pharmatech Associates, Inc., United States
Combination products in the US are becoming mainstream in the healthcare industry. While there are a number of resources focusing on premarket and post-market requirements for combination products, the requirements for labeling, advertising and promotion are often neglected or under-emphasized.Labeling requirements for combination products (including advertising and promotion) are dictated by the product’s primary designation (i.e. drug, device or biologic). However, there are nuances unique to combination products that companies must consider, especially for companies expanding from a traditional pharma or device platform to combination products. Aside from different requirements, there are also different philosophies in how each industry develops labeling and the development of claims for use in advertising and promotion. Many combination products are intended for “home-use”. Health literacy and human factors are critical to the labeling process for these products. How should manufacturers practically address human factors in its product labeling? What about individually packaged devices intended to be used with an individually packaged drugs; or co-packaged combination products? - what is cross-labeling and how can it be practically managed? Do co-packaging products impact labeling? And, what opportunities the future of devices references drugs and cross-labeling may bring. Case examples will be presented, and a panel of experts share their experiences and answer audience questions. This session will be interactive and audience participation is highly encouraged.
Learning Objective : Describe the regulatory labeling/AdPromo nuances and challenges specific for different types of combination products; Discuss differences in labeling development and approaches to support promotional claims in the pharma and device industries; Identify how to practically address human factors for “home use” combination products; Describe the components of cross-labeling, and the unique challenges related to implementation.
Utilization of Human Factors Studies
Darin Seth Oppenheimer, DrSc, MS, RAC
Executive Director, Drug Device Center of Excellence
Merck & Co., Inc., United States
Cross Labeling and Devices Referencing Drugs
Alexander Varond, JD
Goodwin Procter LLP, United States
Labeling and Ad/Prom Challenges for Combination Products
Anthony Genovese, PharmD
Deputy Director, Advertising and Promotion
Bayer Healthcare, United States