Practices: Federal

Our experience with the issues, the process, and the decision-makers in Washington, D.C. brings to each task a unique combination of public policy and legal skills that provides our clients the opportunity to impact federal policy. We routinely appear before the Department of Health and Human Services, the Food and Drug Administration, the Department of Justice, the Federal Trade Commission, the Environmental Protection Agency, the Department of State, the Department of Defense, the Small Business Administration, the Department of Transportation, and the Department of Agriculture on behalf of our clients. In addition, the firm maintains a strong presence before the U.S. House of Representatives and the U.S. Senate.

Specific examples of work in Washington, D.C. include:

• Working with the Consumer Product Safety Commission;
• Advocating product liability reform legislation on behalf of a Fortune 200 Company;
• Advising clients before the Department of the Treasury, SEC, and CFTC;
• Advising a Fortune 100 Company on various sources of funding for research and development of specific product lines;
• Working with various clients before the Senate Finance and House Ways and Means Committee;
• Working with the Department of Justice and the Army Corps of Engineers on a major environmental initiative on behalf of a chemical company;
• Working with the Department of Justice and related agencies on antitrust issues;
• Obtaining congressional support to oppose an agency action that was unsupported by science and sound public health policy;
• Advocating before various federal agencies, including FDA, OSHA, and DOT on regulatory matters impacting clients;
• Providing FDA with advice on how to set new industry standards for manufacturing vital healthcare equipment;
• Working with the Department of Justice and related agencies to prevent a “hostile takeover” of a company;
• Working as part of a consortium of manufacturers to reform the False Claims Act;
• Negotiating a regulatory position with the Department of Labor on behalf of a major healthcare company;
• Obtaining legislative and regulatory relief for a startup airline company;
• Working with local authorities to secure FAA discretionary funds under the Airport Improvement Program;
• Helping local airports to obtain new airline service from the DOT;
• Addressing major superfund recycling issues before the EPA;
• Working with the Federal Reserve Board to assist our client during a hostile takeover;
• Counseling and defending food, drug, medical device and other companies and individuals with respect to FDA inspections and enforcement actions;
• Counseling numerous companies on compliance issues regarding FDA, Federal Trade Commission, EPA, USDA, U.S. Customs Service, U.S. Consumer Product Safety Commission, and numerous state laws;
• Reviewing and developing label and advertising copy for compliance with the requirements of FDA, FTC and USCS;
• Preparing and submitting Food Additive Petitions to FDA;
• Defending criminal prosecutions for violations of the Federal Food, Drug and Cosmetic Act;
  Obtaining Letters of No Objection from FDA and USDA for food-contact substances and processes;
• Providing opinions on the regulatory status of substances that are potential direct or indirect food additives;
• Rendering opinions that substances are Generally Recognized As Safe; and
• Advocating transportation issues before the Department of Transportation for a national railroad company.