Our internationally leading Food and Drug Practice includes representation before the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and United States Department of Agriculture (USDA), and litigation at all levels in the federal courts. In addition, the firm has represented numerous clients in state food and drug law matters. The firm represents clients in each of the product categories regulated by FDA and USDA, including human prescription and nonprescription drugs, food, medical devices, human and veterinary biological products, animal feeds and drugs, cosmetics, tobacco products, and electronic radiation products.
Firm lawyers have participated in matters relating to drug and device approvals, clinical trials, hearings on drug approval withdrawals, and various enforcement and rulemaking proceedings. We have extensive experience in GMP and quality system compliance, review of labeling and advertising claims, FTC regulatory and enforcement proceedings, Lanham Act false advertising cases, and self-regulatory advertising proceedings before the National Advertising Division (NAD) of the Council of Better Business Bureaus.
We advise pharmaceutical and device manufacturers and other health care providers on matters related to Medicare and Medicaid, including obtaining favorable Medicare coverage and reimbursement, Medicaid drug rebate requirements, and compliance with the Medicare Anti-Fraud and Abuse Act. Our in-depth knowledge of the inner workings of the FDA and the Centers for Medicare & Medicaid Services (CMS) enables us to assist our clients in developing optimal strategies for product development, approval and reimbursement. In appropriate circumstances, these strategies may include a legislative component, developed in collaboration with the firm’s Public Policy and Government Affairs practice.
The firm has served as general counsel or principal outside counsel to over 20 trade associations in the food and drug area and related fields, including the Animal Health Institute, the American Bakers Association, the American Forest & Paper Association, the Compressed Gas Association, the Corn Refiners Association, the Personal Care Products Council, the International Dairy Foods Association, the National Pharmaceutical Council, and the Consumer Healthcare Products Association. In addition, we represent on specific projects a number of other trade associations, including the Biotechnology Industry Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Corn Refiners Association.
We assist our food, drug and device clients in crisis management, advising on the many legal issues that are raised by FDA inspections, quality failures, recalls, tampering, extortion demands, and other episodes raising potential threats to public health. Our involvement has included advice and representation on such matters as: evaluation of a company’s obligation to initiate a recall; consultation with FDA and USDA enforcement officials; potential exposure of companies and employees to criminal or other enforcement sanctions; recall notifications and statements to the media and product liability considerations. We regularly provide assistance on FDCA compliance issues in connection with criminal and civil investigations by the U.S. Department of Justice, the Office of Inspector General of the Department of Health and Human Services, and state attorneys general of issues relating to the manufacture, sale and promotion of pharmaceuticals and medical devices.
Firm legislative activities include legislative analysis, preparation of draft legislation, Congressional testimony, interaction with Congressional members and staff, and evaluation of recent statutory enactments.
Our attorneys advise on international food and drug law matters, through the London, Brussels, and Washington offices, including advice on national requirements and monitoring European Community activities.