INDUSTRIES & EXPERIENCE
Our clients range from small startups to large multinational companies.
We focus on integrated strategies and individual services in law, policy, and politics for life sciences, technology, and other highly regulated industries. We partner with our clients to strengthen their position for greater offensive and defensive advantage.
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.
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.
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.