Ben Haas practices in Latham & Watkins’ Washington, D.C. office, where he is a corporate partner in the Healthcare and Life Sciences Practice Group. Mr. Haas focuses his practice on regulatory, transactional and legislative matters involving the medical device, pharmaceutical, biotechnology, tobacco, food, cosmetic and dietary supplement industries. Mr. Haas has counseled clients on a wide variety of regulatory matters involving the US Food and Drug Administration (FDA), including, among others:
- Pre-market product development and clinical and pre-clinical testing
- FDA submissions
- Product promotion and labeling
- Compliance with good manufacturing practice requirements
- Agency inspections and recalls
In the transactional area, Mr. Haas provides counsel on corporate compliance, mergers and acquisitions, and other corporate transactions. He regularly assists FDA-regulated device companies in initiating, managing and completing large, international clinical trials. He has counseled clients regarding clinical trial strategy; contracting with and managing clinical research organizations, other clinical trial vendors, and clinical trial sites and investigators in the US and in dozens of overseas jurisdictions; and communicating with US and foreign regulatory authorities, as well as institutional review boards and ethics committees, both domestic and foreign. Mr. Haas has also drafted and negotiated several types of agreements for healthcare clients, including manufacturing and supply, licensing, joint development, consulting and marketing and distribution contracts. Finally, Mr. Haas has conducted regulatory diligence for major public and private financings, mergers and other transactions in the device, pharmaceutical, biotechnology and dietary supplement industries.
Mr. Haas also counsels clients on legislative and administrative rulemaking proceedings relating to the FDA, including issues resulting from the implementation of the Family Smoking Prevention and Tobacco Control Act of 2009, the Food and Drug Administration Amendments Act of 2007, the Medical Device User Fee and Modernization Act of 2002, the Bioterrorism Act of 2002, and the Medicare Prescription Drug Improvement and Modernization Act of 2003. He has also worked with trade associations and other clients to address specific regulatory issues in matters before several federal agencies, including the Environmental Protection Agency, Federal Trade Commission, Department of Transportation, US Department of Agriculture and Drug Enforcement Administration.
Mr. Haas has been recognized by leading publications for his work in the life sciences industry. He is recommended by The Legal 500 US in the Life Sciences category (2015) and LMG Euromoney named him a “Life Sciences Star” in the Regulatory category (2015).
Mr. Haas also served as a member of the Latham's Global Training and Career Enhancement Committee.
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:
- “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)
- “Associates’ Corner: FDA Issues Guidance on Pharmacogenomic Data,” Latham & Watkins Client Alert (March 2004)