Alan G. Minsk

Partner

Phone: 404.873.8690
Fax: 404.873.8691
Atlanta
171 17th Street NW
Suite 2100
Atlanta, Georgia 30363

Biography

Alan is a partner and leader of the Food & Drug Practice Team. Alan is licensed to practice in Georgia and Washington, DC. 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 – 2017. Nominees are selected based upon comprehensive, independent survey work with both General Counsel and private practice lawyers worldwide. 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.

Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, 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 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-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 he tries to educate as well, eschewing legalese, so clients understand the issues and parameters to solutions. Alan also provides for 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 co-editor of AGG’s Food and Drug Newsletter. He has spoken throughout the U.S. and in Canada, England, Belgium, Israel, Luxembourg, Germany, and the Netherlands.

He currently serves on a number of editorial boards for professional publications, including the RAPS Focus magazine, the Law Journal Newsletter’s Product Liability Law and Strategy, and the Food and Law Drug Institute’s Food and Drug Journal. He serves on a number of other professional boards and currently serves as the Vice President of the Atlanta Jewish Academy.

Related Services

Related Industries

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    Experience

    • Assisted with the review of agreements for Puma Biotechnology for clinical trials of a new breast cancer medication to be conducted in Russia.

    • Advised a U.S. biotechnology company in connection with clinical trials of a new breast cancer medication to be conducted in Russia.

    • Assisted clients with preparation of Regulatory Opinion Letters for IPO filings.

    • Counseling pharmaceutical companies on regulatory issues relating to 505(b)(2) new drug applications and orphan drug issues.

    • Counseling a New York-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

    • Serves on multiple client promotional review boards for pharmaceutical and medical device companies as the legal representative to ensure  regulatory compliance of FDA’s labeling and promotional requirements.

    • Counseling a California-based biopharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.

    • Counseling a pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.

    • Counseling a Montreal-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

    • Counseling a pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.

    • Counseling a Pennsylvania-based pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.

    • Serving on client review board for a North Carolina-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.

    • Serving on client review board for a Montreal-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.

    • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.

    • Counseling a Georgia-based medical services manufacturer on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

    • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.

    • Counseling a California-based pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.

    • Counseling a biopharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.

    • Counseling an Alabama-based manufacturing company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

    • Helped prepare a Citizen Petition, submitted by King Pharmaceuticals, a publicly traded company subsequently acquired by Pfizer, defending a challenge to the company’s sale of an approved drug product; the product remains on the market to date.

    • Represented a number of pharmaceutical clients before local FDA district offices and the FDA’s Office of Compliance to develop proactively a phase-out program of Drug Efficacy Study Implementation (DESI) products before the FDA took enforcement action against the companies.

    Client Successes

    Credentials

    Education
    • Georgetown University Law Center, Juris Doctor — 1992
    • Brandeis University, Bachelor of Arts — 1989,

      summa cum laude, Highest Honors in Politics

    Admissions
    • District of Columbia Bar – 2011
    • State of Georgia – 1992
    Court Admissions
    • United States District Court for the Northern District of Georgia – 1997
    • Supreme Court of Georgia – 1993
    • Georgia Court of Appeals – 1993
    Associations
      • University of Georgia Regulatory Affairs Graduate Educational Program Advisory Board
      • Food and Drug Law Journal, Editorial Board
      • Product Liability Law and Strategy, Editorial Board
      • Pharmaceuticals Policy and Law, Editorial Board
      • Atlanta Jewish Academy, Board of Trustees President
      • Regulatory Affairs Professionals Society Focus, Editorial Advisory Board
      • Georgia Biomedical Partnership
      • Food and Drug Law Institute
      • Southeastern Medical Device Association
      • Center for Communication Compliance Advisory Board
      • Conexx: America Israel Business Connector
      • Drug Information Association
      • Regulatory Affairs Professionals Society—Georgia Chapter, former Leader
    Languages
    • Hebrew ( Proficient )

    Recognition

    • Best Lawyers in America (FDA Law), 2018-2020
    • Chambers USA: America’s Leading Lawyers for Life Sciences, Regulatory/Compliance, 2015-2019
    • The International Who’s Who of Life Sciences Lawyers (Regulatory chapter), 2013-2017, 2019

    News & Insights

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