J. Benneville (Ben) Haas

Ben Haas, Global Vice Chair of the Healthcare & Life Sciences Practice, advises clients across all stages of pre- and post-market US Food and Drug Administration (FDA) regulation and compliance.

Mr. Haas leverages extensive experience and a sophisticated understanding of FDA-regulated products to guide medical device, pharmaceutical, biotechnology, tobacco, food, cosmetic, and dietary supplement companies on:

• Pre-market product development, clinical, and pre-clinical testing
• FDA submissions
• Product promotion and labeling
• Compliance with good manufacturing practices
• Agency inspections and recalls
• Regulatory diligence for major public and private financings, mergers, and other transactions

Mr. Haas advises on corporate compliance, mergers and acquisitions, and other corporate transactions, and counsels on legislative and administrative rulemaking proceedings relating to healthcare government mandates.

Mr. Haas also counsels clients on compliance and regulatory matters arising under the Consumer Product Safety Act (CPSA) and other statutes administered by the US Consumer Product Safety Commission (CPSC). He also helps clients design and implement product recalls within the CPSC’s jurisdiction.

A recognized thought leader and member of the FDA bar, Mr. Haas serves on multiple steering committees for the Food and Drug Law Institute and regularly speaks on FDA regulatory and enforcement matters. He has also written articles for the Food and Drug Law Institute’s Update Magazine and the Pharmaceutical Law & Industry Report.

Thought Leadership

Mr. Haas has authored and co-authored articles on FDA regulatory matters, including articles in the Food and Drug Law Institute's Update Magazine and the Pharmaceutical Law & Industry Report, and has been a featured speaker and lecturer on FDA regulatory and policy matters at industry-sponsored events. Some of Mr. Haas’ recent publications include:

• “FDA Works to Increase Competition Under Commissioner's Drug Competition Action Plan,” Latham & Watkins Client Alert June 2017 
• “FDA Issues Draft Guidance on Biosimilar Interchangeability,” Latham & Watkins Client Alert January 2017
• “President Obama Signs the 21st Century Cures Act Into Law,” Latham & Watkins Client Alert December 2016
• “Highlights of the FDA’s Abbreviated New Drug Applications,” Latham & Watkins Client Alert October 2016
• “Tobacco and Nicotine Delivery: Regulation and Compliance, Second Edition” FDLI July 2016
• “FDA to Regulate E-Cigarettes, Cigars and Other Tobacco Products,” Latham & Watkins Client Alert May 2016   
• “Human Clinical Trials and Drug Approvals: Transnational Issues,” chapter from Food and Drug Regulation in an Era of Globalized Markets September 2015   
• “FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices,” Latham & Watkins Client Alert August 2014   
• “Medical Device IDEs: FDA Continues Effort Toward Greater Efficiency and Transparency,” Latham & Watkins Client Alert July 2013   
• “FDA Issues Draft Guidance on Expedited Review Programs, Including Breakthrough Therapy Designations,” Latham & Watkins Client Alert July 2013   
• “EU Proposes Overhaul of Clinical Trial Procedures,” Latham & Watkins Client Alert July 2012   
• “Medical Device Benefit-Risk Determinations: FDA Releases a Novel Guidance Giving Industry an Inside View of Agency Decision-Making,” Latham & Watkins Client Alert April 2012
• “FDA Issues Draft Guidance for In Vitro Companion Diagnostic Devices,” Latham & Watkins Client Alert July 2011   
• "FDA Moves to Clarify Nanotechnology Guidelines,” Latham & Watkins Client Alert June 2011
• “Supreme Court Holds That Bayh-Dole Act Does Not Automatically Strip Employees Of Rights In Their Federally Funded Inventions,” Latham & Watkins Client Alert June 2011
• “An Ounce of Prevention: FDA Issues First Rules Under FSMA Intended to Prevent Unsafe Food from Entering the Market,” Latham & Watkins Client Alert (June 2011)
• “Matrixx Initiatives, Inc. v. Siracusano: Changes in Adverse Event Reporting,” Latham & Watkins Client Alert April 2011
• “Medical Device Reform Is (Almost) Here: FDA Announces Action Items for Improving The Agency’s 510(k) Premarket Clearance Process,” BNA’s Medical Devices Law & Industry Report March 2011   
• “FDA Announces Actions Designed to Improve the 510(k) Premarket Clearance Process,” Latham & Watkins Client Alert January 2011   
• “FDA Revises Informed Consent Regulations to Incorporate Clinical Trial Registration Requirements,” Latham & Watkins Client Alert January 2011
• “FDA Revises Safety Reporting Requirements for Investigational New Drug and Bioavailability and Bioequivalence Studies,” Latham & Watkins Client Alert November 2010   
• “Not Yet: Patented Risk Evaluation and Mitigation Strategies May Delay (or Tax) Competitors,” Intellectual Property Today June 2009
• “The Web of Clinical Trial Registration Obligations: Have Foreign Clinical Trials Been Caught?” Food and Drug Law Journal, Vol. 64 No. 2 June 2009
• “FDA Issues Clarification of US Clinical Trials Registry Requirements,” Latham & Watkins Client Alert January 2009
• “Looking Abroad: Clinical Drug Trials,” Food and Drug Law Journal, Vol. 63, No. 3 September 2008
• “Increased Scrutiny of Investor Communications by Federal Regulators,” FDLI’s Update Magazine January 2006
• “FDA-SEC Initiative May Signal Increased Scrutiny of Investor Communications,” Latham & Watkins Client Alert March 2004