David Adams is nationally recognized as a leading attorney in the Food and Drug bar. Mr. Adams brings years of experience with Food and Drug Administration to advise companies on product development, approval, and marketing. Mr. Adams' practice concentrates on FDA approval and marketing of drugs, devices, and biologics, as well as regulation of food and dietary supplements. He also represents clients before other agencies such as the Federal Trade Commission (FTC), Drug Enforcement Administration (DEA), and the Centers for Medicare and Medicaid Services (CMS), as well as before the courts, Congress and the National Advertising Division of the Better Business Bureaus (NAD). His work encompasses: · regulatory counseling · lobbying · private business negotiation · litigation · advocacy before federal agencies and NAD · serving as expert witness Prior to joining Venable, Mr. Adams held senior positions at the Food and Drug Administration including: · Associate Chief Counsel for Drugs, Office of the Chief Counsel · Associate Chief Counsel for Enforcement, Office of the Chief Counsel · Director of the Policy Development and Coordination Staff, Office of the Commissioner Mr. Adams is recognized in The Best Lawyers in America for FDA Law. Representative Clients Mr. Adams represents manufacturers and distributors of prescription and over-the-counter medications, medical devices, cutting-edge biotechnology products, foods, dietary supplements and cosmetics. He also represents trade associations for FDA-regulated companies and medical and professional societies. Significant Matters · Mr. Adams has provided counsel on numerous drug, device, biologic and food issues and appeals before the FDA. · He has successfully represented companies in complex litigation involving FDA's approval processes and other regulatory issues. · Mr. Adams has represented clients in FTC, criminal and Congressional investigations. · He has successfully lobbied Congress on important food and drug legislation. Activities Mr. Adams teaches Food and Drug Law at the George Washington University Law School. He is an editor of Food and Drug Law and Regulation, a food and drug law reference text. Mr. Adams has served as chair of the Food and Drug Law Committee of the ABA Section of Business Law, as well as chair of the editorial board for the Food and Drug Law Journal. Industries Pharmaceuticals Consumer Products and Services Drugs, Medical Devices and Biologics Dietary Supplements, Cosmetics and Functional Foods Life Sciences Government Experience Associate Chief Counsel for Drugs, Food and Drug Administration Director, Food and Drug Administration, Policy Development and Coordination Staff Judicial Clerkships Honorable Winston E. Arnow, Chief Judge, U.S. District Court for the Northern District of Florida, 1977 - 1978 News December 5, 2011, Venable announces new Government Division leadership team November 29, 2011, 11 Venable attorneys included in Washingtonian's "Washington's Best Lawyers" September 14, 2011, 75 Venable attorneys listed in The Best Lawyers in America® 2012 November 12, 2010, David Adams quoted on FDA plans for criminal prosecutions of pharmaceutical company executives August 23, 2010, 65 Venable attorneys receive 2011 Best Lawyers honors December 3, 2009, David Adams quoted in FDA Webview on FDA regulation of the Internet November 23, 2009, 13 Venable attorneys included in Washingtonian's "Washington's Top Lawyers" November 5, 2009, Best Lawyers recognizes 24 Washington-area Venable attorneys in Washington Post supplement August 25, 2008, Fifty-nine Venable Attorneys Earn Best Lawyers in America Honors September 12, 2007, Fifty-five Venable Attorneys Earn Best Lawyers in America Honors October 2, 2006, Forty-Seven Venable Lawyers Cited Among The Best Lawyers in America April 27, 2006, Seventeen Venable Lawyers Cited Among "Best Lawyers in America" in the Washington Area Honors AV® Peer-Review Rated by Martindale-Hubbell Listed in The Best Lawyers in America, FDA Law, (Woodward/White, Inc). Recognized in 2011 by Washingtonian magazine as one of "Washington's Top Lawyers" 2011, Editor, Food and Drug Law and Regulation, Second Edition
David G. Adams 2008, Editor, Food and Drug Law and Regulation
David G. Adams October 22, 2007, A Two-Cigarette Society
David G. Adams
The New York Times. 2005, Best Practices for Food and Drug Law: Leading Lawyers on FDA Approval Strategies, Industry Regulations, and Client Communication
David G. Adams 2005, Essential Elements of FDA Practice and Strategy
David G. Adams
Best Practices for Food and Drug Law November 12, 2004, Dietary Supplement Health Education Act (DSHEA)
David G. Adams, Todd A. Harrison October 25, 2004, New California Law Mandates Compliance with OIG Guidance and PhRMA Code
David G. Adams, Peter P. Parvis 1998, Key Provisions of the Food and Drug Modernization Act Relating to Drugs and Biologics
David G. Adams
Fundamentals of Law and Regulation Supplement 1997, Editor,
Fundamentals of Law and Regulation Vol. II: An In-Depth Look at Therapeutic Products
David G. Adams 1995, USPTO and FDA Rulings Limit Uruguay Round Agreements Act Benefits and Protections for Certain Patents on FDA-Regulated Products
David G. Adams
136 Legal Mind 731, Japan 1995, FDA's Final Regulations on Generic Drug Approval: Marketing Exclusivity
David G. Adams
131 Legal Mind 59, Japan 1994, FDA Regulation of Communications on Pharmaceutical Products
David G. Adams
24 Seton Hall L. Rev. 1399 1994, FDA's Final Regulations on Generic Drug Approval: Patent Protections, Patent Challenges
David G. Adams
128 Legal Mind 66, Japan 1993, FDA Policy on Industry-Supported Scientific and Educational Activities
David G. Adams
47 Food and Drug Law Journal 624 1992, Pharmaceutical Advertising: Education versus Promotion (reprinted as Promotion of Pharmaceuticals)
David G. Adams
J. of Pharmaceutical Marketing and Management 53 Events/Speaking Engagements Past Events June 28, 2011, "Navigating the New Law on Licensing Biosimilars" at the BIO 2011 International Convention
David G. Adams June 28, 2011, "Talking About Your Product in the New Age: Social Media and the Internet" at the BIO 2011 International Convention
David G. Adams June 13, 2011, "Globalization of Clinical Trials, Data Integrity and Pre-Market Approvals" at the Food and Drug Law Institute's US-China Conference
David G. Adams April 28, 2011, FDA Workshop NYC, Independent Cosmetic Manufactures and Distributors (ICMAD)
David G. Adams, Sharon A. Blinkoff March 16, 2011, "The Drug and Biologic Approval Processes" at the American Conference Institute
David G. Adams July 21, 2010, "The New Biosimilars Framework: Outlining the Issues as FDA Begins Implementation" webinar for The Food and Drug Law Institute
David G. Adams June 29, 2010, "Navigating the New Law on Licensing Biosimilars" Webinar, presented by Venable LLP
David G. Adams, Jill B. Deal April 29, 2010, FDA Cosmetic Regulations Workshop
David G. Adams, Sharon A. Blinkoff March 24, 2010, "Drug and Biologic Approval" at the American Conference Institute
David G. Adams March 3, 2010, "Social Media and the Internet" at the Annual Meeting of the New York State Bar Association
Sharon A. Blinkoff, David G. Adams December 8, 2009, "FDA Regulation of Marketing" at the FDA Fellow Program
David G. Adams November 6, 2009, "Regulation of Drug Marketing" at the FDLI Drug Law Workshop
David G. Adams February 5, 2009, "Generic Drug Approval Issues" at the FDLI Program on Hatch-Waxman
David G. Adams 2008, "Marketing Biologics" at the Food and Drug Law Institute
David G. Adams 2007, "Patents, Exclusivity, and Generic Drugs" at the Food and Drug Law Institute
David G. Adams April 12, 2007, "Regulation of the Follow-On Biologics" at the 50th Annual FDLI and FDA Conference
David G. Adams March 27, 2007, Tech Counsel of Maryland General Counsel's Roundtable
David G. Adams 2007, "Regulation of Follow-On Biologics" at the Food and Drug Law Institute
David G. Adams 2006, "Recent Cases Involving Promotion of Off-Label Use" at the Thompson Interactive Audio Program
David G. Adams 2006, "Legislative Proposals Regarding Follow-On (Generic) Biologics" at the Food and Drug Law Institute
David G. Adams October 27, 2006, "How an Off-Label Use Becomes Your Intended Use" at the Center for Business Intelligence Annual Program
David G. Adams 2006, "Liability for Off-Label Promotion" at the HCPro Audioconference
David G. Adams 2006, "Introduction to Drug Law" at the Food and Drug Law Institute
David G. Adams 2006, "Legislative Proposals Regarding Follow-On Biologics" at the Food and Drug Law Institute
David G. Adams 2006, "Patents, Exclusivity, and Generic Drugs" at the Food and Drug Law Institute
David G. Adams 2006, "Introduction to Drug Law" at the Food and Drug Law Institute
David G. Adams 2006, "Recent Cases Involving Promotion of Off-Label Use" at Thompson Publishing
David G. Adams 2006, "A Question of Intent" at the Center for Business Intelligence
David G. Adams 2005, "Regulatory Liability Based on Intended Use" at the Drug Information Association
David G. Adams 2005, "NDAs, ANDAs, Patents, and Exclusivity" at the Food and Drug Law Institute
David G. Adams 2005, "Regulatory Liability Based on Support for CME" at the Medical Education Congress
David G. Adams 2004, "Product Life Cycle Management" at the Pharmaceutical Education Association
David G. Adams June 15, 2004, "Enforcement Beyond the FDZ: Justice Department, Attorneys General and HHS IG" at the Drug Information Association Annual Meeting
David G. Adams June 14, 2004 - June 15, 2004, FDLI's Introduction to Drug Law and Regulation Workshop
David G. Adams 2004, "Disseminating Product Information Prior to Approval" at the American Conference Institute
David G. Adams 2004, "Current Issues in Regulation of Continuing Medical Education" at the Drug Information Association
David G. Adams 2004, "FDA Regulation of Marketing" at the Food and Drug Law Institute
David G. Adams 2004, "Product Life Cycle Management" at the Pharmaceutical Education Association
David G. Adams 2003, "Current Issues in FDA Regulation of Prescription Drug Promotion" at the Drug Information Association
David G. Adams 2003, "Current Issues in FDA Regulation of Prescription Drug Promotion" at the Drug Information Association
David G. Adams 2002, "FDA's First Amendment Review" at the Food and Drug Law Institute
David G. Adams 2002, "Constitutional Limitations on FDA Regulation of Promotion" at the Federalist Society
David G. Adams 2002, "FDA Regulation of Drug Marketing" at the Drug Information Association
David G. Adams 2001, "Pre-Approval Promotion: How to Do It Legally" at the Drug Information Association
David G. Adams 2001, "Industry-Supported Information on Therapeutic Products" at the American Medical Association
David G. Adams 2001, "Current FDA Enforcement of Drug Advertising Requirements" at the Drug Information Association
David G. Adams 2000, "Current FDA Enforcement of Drug Advertising Requirements" at the Drug Information Association
David G. Adams 2000, "Constitutional Challenges to FDA Implementation of FDAMA" at the Drug Information Association
David G. Adams 2000, "Federal Regulation of Drug Information on the Internet" at the American Conference Institute
David G. Adams |