Legal Perspective on Recent FDA Enforcements
Heather Bañuelos and Gillian Russell of King & Spalding will be presenting at the Life Science Advertising & Promotions Regulatory Affairs Conference this July. Preview their session “Update on Recent Enforcement of Regulations & Guidances Related to Advertising & Promotions” below.
Can you please give a description of your job title and what your position entails?
We both serve as Counsel in the FDA & Life Sciences practice at King & Spalding. Our practice focuses almost exclusively on advertising and promotion issues related to pharmaceutical and medical device products. On a day-to-day basis, we advise clients on questions related to promotional and non-promotional communications, regularly addressing questions that are more complicated and controversial. This includes both pre-commercial and commercial companies and products. We have each served as the legal and/or regulatory representative on dozens of promotional review committees and medical and scientific review committees. Our goal is to work seamlessly with clients to help evaluate and assess risks to compliantly achieve their marketing and communications goals.
Can you give a brief summary of the presentation?
We frequently present updates on FDA enforcement, research and policy related to advertising and promotion. Based on current examples, we identify important trends and topics from government activities to help inform companies’ evaluations of promotional and non-promotional activities. During this session, we will discuss recent FDA and other government activities related to advertising and promotion of prescription drugs and devices. Understanding current enforcement, regulations and policy is critical to assessing compliance, including legal and regulatory risks, in promotional and non-promotional communications. This session will include a discussion of recent drug and device related advertising and promotion enforcement letters, FDA guidance, FTC guidelines pertinent to social media and influencers and the new CMS requirement for drug price disclosures in DTC television ads.
How does staying updated on regulations lead to optimal decision making?
Staying up to date on regulations is important to evaluating compliance for promotional and non-promotional communications. Because few updates are made to FDA regulations for advertising and promotion, it becomes even more critical to stay updated on FDA enforcement letters, guidance, social sciences research and related activities by other government agencies, such as the FTC. A comprehensive review and understanding of all applicable activities will better inform internal decision-making about advertising and promotion strategies.
What are the main takeaways you hope attendees learn from the presentation?
At the conclusion of our presentation, we hope attendees will understand the current legal and regulatory trends and topics related to advertising and promotion, and any looming or anticipated changes.
Why do you believe regulatory affairs advertising and promotions professionals should attend this event?
This conference offers a variety of relevant and thought-provoking presentations on advertising and promotion topics that will benefit regulatory affairs professionals. In the current landscape, it is important to stay up to date on current and anticipated legal and regulatory developments, which are always evolving and changing. Such knowledge and understanding is important to effectively advise one’s organization and clients consistent with applicable laws and policies. Conferences like this provide an opportunity to learn, engage and network with some of the best in the field.
Save your spot for an upcoming Advertising & Promotions Regulatory Affairs program today to learn more about recent FDA and FTC enforcements.