Alan G. Minsk is a partner and leader of the Food and Drug Practice Team. Mr. Minsk is licensed to practice in Georgia and Washington, DC. He works out of AGG’s Atlanta and Washington offices.
Mr. Minsk was recently recognized by Chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers 2013 and 2014. Nominees are selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. Mr. Minsk also serves as practice leader of the Food and Drug Practice, which is recognized in U.S. News Media Group and Best Lawyers 2011–12 "Best Law Firms" rankings as one of the top food and drug practices in the nation. He serves as general counsel of PDMA Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability.
Mr. Minsk focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic and food companies, on all legal and regulatory matters relating to the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). For companies in the pre-approval phase, Mr. Minsk counsels on clinical trial issues, communications with the FDA during the review process, imports and exports, regulatory strategy including 505(b)(2) new drug applications, orphan drugs, combination product, designations, market exclusivity, premarket notifications, premarket approval applications and pre-approval discussions. He also drafts and reviews agreements relating to clinical trials, quality and contract manufacturing. For companies in the commercial phase, Mr. Minsk advises on lifecycle management, post-market surveillance, citizen petitions, FDA enforcement and inspections, fraud and abuse compliance, promotion and advertising, product liability, and interactions with the FDA. In addition, Mr. Minsk works with life science companies and venture capital firms on regulatory diligence matters involving acquisitions, divestitures, co-promotions and licensing. Mr. Minsk conducts in-house training on FDA and fraud and abuse topics.
Mr. Minsk’s client base is primarily focused on early-stage to mid-sized 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 Mr. Minsk tries to educate as well, eschewing legalese, so clients understand the issue and parameter and to solutions. Mr. Minsk is also a highly sought-out speaker for in-house training seminars and conference presentations. He previously worked in Washington DC for a food and drug boutique law firm.
Mr. Minsk has written book chapters, articles and bulletins on a wide variety of issues, including 505(b)(2) NDAs, orphan drugs, FDA and promotion, quality agreements, compliance, and medical device regulation. He has spoken throughout the U.S. and in Canada, England, Belgium, Israel, Luxembourg, Germany and the Netherlands.
