Successfully charting today’s highly regulated and complex operating environment often requires early and direct involvement in legislative and administrative processes.  At the same time, businesses and other regulated organizations are also concerned about the legal pitfalls and adverse publicity that may result from ill-conceived approaches in this volatile area.  Our lawyers who practice in governmental affairs fully understand our clients’ need for coordinated, professional, and cost-effective representation.  Lawyers at Ropes & Gray work with clients as part of a team, which can include other lobbying professionals, public relations experts, grassroots advocacy organizations, and non-legal specialists.

Although our practice is national, our roots in Washington grow deep, as our partners come from senior positions with the Environmental Protection Agency and the Securities and Exchange Commission, and on Capitol Hill, as well. In recent years, our lawyers have argued two cases to the U.S. Supreme Court, won a criminal jury trial in Texas, counseled one of the fastest growing families of mutual funds in the nation, formed and led a new trade association to address cutting-edge environmental problems, and charted legislative strategy for the Business Roundtable. Reinforced by the extraordinary talent and depth throughout the firm, our experience yields creative solutions to the government related problems we confront every day in litigation,  environmental law, life sciences, and legislative representation.

How We Help Our Clients

Our mission is to combine legislative, administrative, and subject-matter expertise with analytical, drafting, and strategic skills to provide clients with creative and effective solutions that achieve their business objectives.  We do this by:

• Assisting clients in identifying how Congress, state legislatures, and government agencies might help or hurt them and developing a plan to take advantage of governmental assistance or to defuse potential challenges;
• Carrying out an effective program to secure enactment of favorable legislation beneficial to clients or to oppose harmful legislation;
• Representing clients in administrative proceedings or in informal dealings with government agencies, including the White House and Executive Offices;
• Utilizing Congress and state legislatures to advance clients’ interests before government agencies;
• Coordinating litigation, lobbying, and public affairs activities to magnify desired results;
• Developing broad-based coalitions of consumers and other interested parties in support of legislative or administrative goals identified by clients;
• Organizing congressional coalitions and briefings for Members or staff to highlight client positions on issues under consideration; and
• Monitoring and routinely reporting on legislative and administrative developments in specified areas to enable rapid response by clients.

Practice Focus Areas

Environmental Law

Ropes & Gray has proven ability to help its clients with one of the most significant demands facing modern business: the challenge of meeting environmental responsibilities. The firm's national reputation in environmental litigation is matched by its expertise in Federal environmental policy making. Of the four former Associate General Counsels that have left EPA for private practice since 1986, three have joined Ropes & Gray’s Washington office.

Our lawyers’ special expertise and knowledge of EPA’s inner workings offer an opportunity to learn about upcoming environmental policies and to develop cost-effective strategies that align environmental obligations with business needs. Our goal is to help clients develop compliance approaches that minimize economic and operating impacts. Our lawyers have established expertise in the wide range of statutes that can affect the operation of industrial facilities (RCRA, the Clean Water Act, the Clean Air Act and the Emergency Planning and Community Right to Know Act), as well as those that can affect products in commerce (TSCA, FIFRA, and the Consumer Product Safety Act).

For clients seeking to bring new products and technologies to market, our lawyers can guide them through the maze of regulatory obstacles to commercialization and identify the opportunities for those technologies created by governmental programs. In addition, we have extensive experience in fields that promise to have a major impact on business operations in the next several years, including "public right to know" disclosure requirements and international environmental policies.

When litigation is necessary to resolve environmental issues, Ropes & Gray has the experience to advocate its clients’ interests vigorously.

FDA Regulatory

Ropes & Gray provides counsel, representation, and strategic advice to companies subject to Food and Drug and related law.  Command of FDA regulatory matters and associated issues in patent and antitrust law is critical when seeking product approvals, developing an effective lifecycle management strategy, and in assuring that products are marketed in compliance with federal and state requirements. Our lawyers have served in Congress and in the administrative agencies of the federal government; this experience is extraordinarily valuable when designing and carrying out a plan to address our clients’ concerns.

We advise established and development-stage pharmaceutical and medical device manufacturers and distributors on the requirements and strategies to pursue marketing authorizations including NDAs, BLAs, PMAs, and 510(k)s. With more than 25 years of experience on Hatch-Waxman Act and Orphan Drug issues, we have an in depth understanding of the competitive issues that affect the industry. We are also recognized leaders in the field of pharmaceutical promotion and compliance and have represented major pharmaceutical and biotech companies in areas ranging from biologics regulation to Rx and OTC switches.

Our FDA experience, combined with our extensive knowledge in related areas such as research funding, health care regulatory matters, clinical trials, and legislation is rare in law firms.  It allows us to thoroughly understand complex issues and to offer our clients an opportunity for coordinated action in conjunction with the firm’s patent, government enforcement, and transactional lawyers in several areas, including:

• Product Approvals
• Labeling, Advertising, and Other Promotional Activity
• FDA Enforcement Actions
• Federal Policy
• Due Diligence Reviews
• Fraud & Abuse
• Reimbursements

Life Sciences

Ropes & Gray has more than 40 lawyers actively involved in providing legal services to the life sciences industry. We believe the depth and breadth of our practice on sophisticated cross-disciplinary issues affecting the life sciences industry are unsurpassed.  Our practice covers the wide range of complex and sophisticated legal and regulatory matters for the life sciences industry including FDA regulatory concerns, intellectual property advice and litigation, and regulation and labeling of genetically modified organisms. (GMOs). 

Legislative Representation

Lawyers from our Washington office provide a variety of services in connection with matters in which the United States government is involved. We have served as lobbyists in tax, antitrust, regulatory reform, environmental, health care, government contracts, and intellectual property matters, among others. We have advised and represented clients during congressional investigations, and we have mobilized congressional interest to assist clients in dealings with federal agencies. We also regularly represent clients directly in proceedings before the Federal Trade Commission, the Treasury Department (Customs, BATF, Tax Legislative Counsel), the Federal Communications Commission, the Securities and Exchange Commission, the Food and Drug Administration, the Department of Agriculture, the Export Administration, and other government organizations.

Contact

For further information on this area of practice, please contact:

• Colburn T. Cherney 
• Mark A. Greenwood 

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