FDA Legal, Regulatory & Compliance Issues, Part 4: Mergers & Acquisitions – FDA Watch
In this fourth and final 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 Brian Teras, Partner in the Corporate & Securities practice at AGG. Together, they discuss current mergers and acquisitions trends and issues for FDA-regulated companies, recent shifts in the M&A environment, the FDA administration’s regulatory approach and its effects on corporate transactions, the FDA Transparency Roadmap and its implications for M&A, common mistakes by buyers and sellers when evaluating deals, emerging FDA regulatory developments that could affect M&A activity, 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.
Brian Teras
Brian Teras is a partner in the Corporate & Securities practice. He works with clients to structure, negotiate, and complete mergers, acquisitions, divestitures, licenses, collaboration agreements, and joint ventures, with a focus on advancing their strategic and operational goals. Additionally, Brian advises public and private companies on securities, corporate finance, and corporate governance matters.
As a trusted advisor, Brian supports clients through SEC reporting and compliance and guides issuers in securities and corporate finance transactions, including registered and private offerings (including Reg D, Rule 144A and Reg A+ offerings). He also advises sponsors of private equity funds, credit and debt funds, venture capital funds, and co-investment funds in fund formation matters, and represents institutional investors in evaluating and participating in a wide range of investment funds.
Drawing from his experience as in-house counsel for an Atlanta-based publicly traded life sciences company, Brian provides clients with a business-oriented, pragmatic perspective — particularly those in the healthcare and life sciences sector. A significant portion of his practice involves advising companies and investors in this space in transactions at all stages of the corporate life cycle, with an acute understanding of their specific needs and challenges.
