Government Affairs & Public Policy
Lewis Brisbois’ Government Affairs & Public Policy Practice is a versatile, multidisciplinary practice group staffed by strategic attorneys who advocate on behalf of clients across several highly regulated industries by leveraging a rare combination of skills and experience to provide powerful solutions at the intersection of law, policy and politics.
We achieve powerful results for clients as lawyers, lobbyists and policy consultants through a combination of cutting-edge work in Washington, D.C. and coordinated outreach into states that are active on key policy issues.
The Practice’s clients include both small startups and large multinational corporations across the biopharmaceutical, health care, natural products, and technology sectors, as well as other highly regulated industries. Our attorneys “see the whole chess board,” working with clients to move the pieces to advance and protect their interests and promote social change at every level of government — federal, state, local or international. We work with industry leaders, stakeholders and all branches of government — executive, legislative, and judicial. We know which pieces to move, and when and how to execute. We help clients engage early to advance goals — to create opportunity or minimize risk.
We regularly assist clients in the following areas:
· Representation before Congress, federal agencies, and state regulatory authorities
· Legal, policy, political, and public relations strategic counseling
· Engagement with federal and state policymakers
· Congressional oversight, inquiries, investigations, and subpoenas
· State AG investigations
· Federal funding and authorizations
· Preparation of key legislation impacting clients’ businesses
· Campaign finance issues
· Promotion of social equity goals
Moreover, our attorneys regularly collaborate with other practices across Lewis Brisbois’ nationwide network so that clients are able to access the comprehensive knowledge and experience that our attorneys offer.
Chair
Vice Chairs
Related Attorneys
Partners
-
Barry Hassenberg
Partner
Los Angeles, CA213.580.3988Attorney Bio
Barry.Hassenberg@lewisbrisbois.com -
Paul W Kisslinger
Partner
Washington, D.C.202.558.0665Attorney Bio
Paul.Kisslinger@lewisbrisbois.com -
Jane C Luxton
Managing Partner
Washington, D.C.202.558.0659Attorney Bio
Jane.Luxton@lewisbrisbois.com -
Michael Marcello
Partner
Providence, RI401.406.3317Attorney Bio
Michael.Marcello@lewisbrisbois.com -
Michael P McGinley
Partner
Madison County, IL618.781.2756Attorney Bio
Michael.McGinley@lewisbrisbois.com -
Cheryl Wilke
Managing Partner
Fort Lauderdale, FL954.495.2220Attorney Bio
Cheryl.Wilke@lewisbrisbois.com
Related News, Publications & Events
Biopharmaceuticals & Health Care
Reshaping Proposed Regulation
Successfully helped a pharmaceutical client reshape a proposed regulation that misapplied the ACA in an overly broad manner, penalized the client financially and conflicted with other important policies of Congress and HHS.
Successes at the FDA
Obtained significant victories with FDA for a U.S. pharmaceutical company (including removal of competitors from our client’s market) to grant our client’s petition and deny the competitor’s application for approval.
Direction on Health Policy Strategies
Helped to guide a pharmaceutical company’s multi-prong health policy strategy, including its approach to changes in the health insurance exchanges under the Affordable Care Act.
Guiding Healthcare Reform
Consistently scored victories to help guide numerous global healthcare enterprises through the legislative process during healthcare reform, including the Affordable Care Act and subsequent debates regarding whether to build on or replace the ACA, 21st Century Cures.
Guiding Regulatory Reform
Guided healthcare clients through policy development and reform in an evolving regulatory climate. We help healthcare clients achieve successful outcomes on issues including essential health benefits, 340B and biosimilars.
Counseling on Policy Considerations and New Regulatory Frameworks
Providing counsel to biotech clients on policy considerations regarding the development by the FDA and CMS of the new regulatory framework for biosimilars.
Interfacing with HHS and Congress
Successfully assisting clients to interface with HHS and Congress to preserve coverage of the company’s product and to repel attempts to subject the product to unduly restrictive reimbursement methodologies.
Navigating Drug Pricing
Guiding several clients through the complex legal, policy and political issue of drug pricing, through pre-launch price development processes and periodic price review, and successfully helping navigate the complex political/policy/legal terrain of Congressional investigations into drug pricing.
Social Impact Strategies
Guided social impact strategies for healthcare clients including patient access, healthcare disparities, and prevention. We develop effective means for healthcare innovators and industry stalwarts to move policy while creating a positive social impact. We identify business and policy opportunities and develop synergies between clients and law and policymakers to increase impact.
Natural Products
Outside Counsel to Major Trade Associations
Served as outside counsel to large natural products trade associations. Helped clients navigate troubled waters and lead industry efforts on many health-related issues (marketing, quality and safety) – on legislative, regulatory and litigation fronts.
Guiding Industry Efforts and Building Bridges
Successfully guided industry effort to interface with and build relationship with skeptical Congressional investigators regarding marketing practice of clients and others in industry.
Developing Best Practices Programs
Developed and helped implement a voluntary agricultural best practices certification program for specialty crop producers and other stakeholders with diverse interests.
Reshaping FDA Guidance Through Congressional Support
Led successful effort to leverage Congressional support to reshape controversial FDA draft guidance that would have significantly limited access to safe and effective dietary supplements contrary to statutory intent.
Marketing and Labeling
We helped industry successfully navigate new and proposed changes to marketing and labeling regulation, including health claims and substantiation, and nutrition labeling. We have spearheaded industry engagement. We fought the FTC’s attempt to change the standard for substantiation of marketing and label claims through efforts in Congress and in court.
Strategies to Navigate Regulations
Help client develop and execute strategy to navigate the State of California’s process to replace its emergency cannabis regulations with permanent regulations.
Guiding GMO Policy
Successfully balanced diverse trade association membership interests to help guide GMO labeling policy.
Preparing for Investigation Hearings
Prepared witnesses to testify in Congressional oversight and investigation hearings.
Defeating Controversial Legislation
Guided successful efforts to defeat a powerful U.S. Senator’s controversial legislation to amend the Food Drug and Cosmetic Act.
Good Manufacturing Practices Development and Compliance
Guided industry policymakers’ and stakeholders’ engagement for trade associations and other clients for the development, implementation, and reform of the good manufacturing for dietary supplements.
Defending Clients in Litigation
Served functional food clients on FDA regulation of “low carb” claims and related class action litigation. Led the defense counsel group and leveraged greater regulatory knowledge to enhance effectiveness. Leveraged policy and Congressional experience to enhance litigation position of a number of clients on disputed interpretation of a new provision of law, leading to favorable settlement.
Technology
Engaging Policymakers on Behalf of Disruptive Innovators
Advised a disruptive innovator regarding strategic engagement of policymakers and its effort to fend off aggression from the traditional disrupted industry.
Helped disruptive innovator to develop strategies on many fronts, including each state, the federal government and U.S. trade policy. Assisted with engagement of members of the Congress and to leverage Congressional connections for needed help in home districts and states.
Counseling on Compliance and Business Strategy
Counseled a technology company to successfully implement its innovative strategic plan while defending from a rival’s aggressive counter-measures. We developed a strategy to counter the rival’s well-devised campaign across the functions of public policy, regulatory, enforcement and litigation, which successfully allowed our client to move forward with its plans.
Advising on International Trade Issues
Helped client navigate the complex legal, policy and political challenges of countervailing duties and antidumping investigations and other controversies relating to international trade.
Latest Posts
Latest News
- May 08, 2024 Josh Cole Aicklen Receives 2023 NBI Outstanding Faculty Award
- May 07, 2024 Steven Lee Speaks With Law360 On Binance Founder’s Prison Sentence
- May 07, 2024 Francis Pileggi Speaks With Law360 About Delaware’s Business Haven Status
Seminars & Webinars
- May 16, 2024 • General Webinar Series Workers’ Compensation: Recent Trends
- June 20, 2024 • General Webinar Series Accident Investigation I: Transportation
- July 18, 2024 • General Webinar Series Social Media & Claims Investigation