FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion – FDA Watch
In this third part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry team at AGG; and Laura LaBrie, Associate in the Healthcare and Food & Drug practices at AGG. Together, they discuss recent actions by FDA’s Office of Prescription Drug Promotion surrounding direct-to-consumer advertising, AI’s role with OPDP enforcement and company promotion and review, and promotional areas getting the most attention in review committees recently. They also address how to navigate issues with competitor promotion, areas in advertising and promotion that could be in focus in 2027, and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Alan Minsk
Alan Minsk is a partner, chair of the Food & Drug practice, and co-chair of the Life Sciences industry team. Alan is licensed to practice in Georgia and Washington, D.C. He works out of AGG’s Atlanta and Washington offices.
Alan is recognized by Chambers USA America’s Leading Lawyers for Life Sciences, Regulatory/Compliance and has been selected for inclusion in the International Who’s Who of Life Sciences Lawyers from 2013-2025. Nominees are selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. He serves as general counsel of The Sharing Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability.
Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, and food (including dietary supplements and medical foods) companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration. For companies in the pre-approval phase, he counsels on the following areas:
- clinical trial issues
- communications with the FDA during the review process
- imports and exports
- regulatory strategy including 505(b)(2) new drug applications
- orphan drug designation
- Fast Track and Breakthrough Therapy designations
- combination product determinations
- market exclusivity
- premarket notification (510(k)) submissions
- premarket approval applications
- pre-approval discussions
For companies in the commercial phase, Alan advises on:
- promotion and advertising
- interactions with the FDA
- lifecycle management (e.g., next-generation products)
- post-market surveillance
- Citizen Petition submissions
- FDA enforcement and inspections
- fraud and abuse compliance
In addition, Alan works with life science companies and venture capital firms on regulatory diligence matters involving acquisitions, divestitures, regulatory opinion letters, co-promotions, and licensing agreements. He also drafts and reviews agreements relating to clinical trials, quality, and contract manufacturing. He conducts in-house training on FDA and fraud and abuse topics.
Alan’s client base is primarily focused on early-stage to mid-size life science companies, where he must clearly articulate the legal and regulatory issues for consideration, while also recognizing the client’s business realities and needs. Clients frequently refer to him as “practical,” “responsive,” and “cost-effective,” and he tries to educate as well, eschewing legalese, so clients understand the issues and parameters of solutions. Alan also provides in-house training for clients and speaks at educational conferences.
Alan has written book chapters, articles, and bulletins on a wide variety of issues, including 505(b)(2) NDAs, orphan drugs, product promotion, quality agreements, compliance, and medical device regulation. He is the editor of AGG’s Food and Drug Newsletter. He has spoken throughout the U.S. and in Canada, Israel, and Europe.
Alan currently serves on the advisory board of the Food and Law Drug Institute’s Food and Drug Journal. He also serves on a number of other professional boards and currently serves as the past president of the Atlanta Jewish Academy.
Laura LaBrie
Laura LaBrie is an associate in the Healthcare and Food & Drug practices and a member of the Hospitals & Health Systems, Life Sciences, and Emerging Technologies industry teams. She is also a member of AGG’s Women in Tech Law initiative.
Laura focuses her practice on a variety of regulatory, compliance, and transactional matters within the healthcare industry, with a focus on FDA-regulated products and industry. As part of the Food & Drug and Life Sciences teams, Laura has handled several aspects of food and drug law, such as pre- and post-market promotion, clinical trial-related documents, product registration and listing, user fee compliance, competitor complaints, and state-specific registration requirements. Laura also offers strategic insight during the pre-market approval stage for FDA-regulated products.
Laura works on a variety of transactions in the healthcare and life sciences space, including De Novo licensure and change of ownership-related issues for healthcare facilities and acquisition or disposition of assets and facilities relating to FDA and USDA-regulated products.
Laura serves as part of the New to FDA Law and Regulation Planning Committee under the Food & Drug Law Institute.
As part of both the Life Sciences team and AGG’s Women in Tech Law, Laura has presented on emerging technology and artificial intelligence-related issues in relation to FDA-regulated products.
While in law school, Laura served on the executive board of the University of Virginia’s Health Law Association and the editorial board of the Virginia Tax Review. She was a pro bono volunteer for healthcare-related issues at the Legal Aid Justice Center in Charlottesville, Virginia, during law school and following her graduation.
Following her first year of law school, Laura worked at the Federal Mine Safety and Health Review Commission for an administrative law judge, where she advised on matters relating to the protection of miners’ rights to a safe working environment and retaliation claims.
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