Food, Drug, and Device

Covington’s internationally leading Food, Drug, and Device Practice encompasses the full range of pharmaceutical, biotechnology, medical device, veterinary, food and beverage, dietary supplement, and cosmetics issues. Through our offices in the United States, Europe, and China and a network of local counsel, we advise trade associations, multinational corporations, and emerging companies on a global basis. We are the only firm ranked “Band 1” for Life Sciences across Chambers’ US, UK, Europe, China, and Global surveys.

In the United States, we represent pharmaceutical, biotechnology, and medical device clients on matters spanning the product life cycle, from product development and clinical trials, through the FDA premarket review process, to postmarketing compliance, including adverse event reporting, Good Manufacturing Practice (GMP) and Quality System requirements, and sales and marketing. We also advise clients on complex issues relating to Hatch-Waxman, biosimilars, and orphan products. As a result of our long and deep work in the area, Covington lawyers have extensive knowledge of the governing laws and regulations, broad-based practical experience with their application, and an intimate knowledge of government regulators and enforcement authorities.

We assist clients in all aspects of food and beverage product development, safety, labeling, and promotion, and have played a key role in the most important legislative developments in the food arena, including advising clients on every new FSMA rulemaking and FDA guidance issued to date. We also have a preeminent regulatory practice relating to veterinary pharmaceuticals, veterinary biological products, pet food, and animal feed. We advise the principal trade association and numerous companies on regulation of cosmetic products.

Our London and Brussels offices include more than twenty-five lawyers who are qualified in various European Union (EU) member states and speak the main languages of the EU. We advise clients on the full range of issues involving pharmaceuticals, biotechnology, devices and diagnostics, foods, cosmetics, and borderline products. We advise on life cycle management planning, pharmacovigilance, EMA transparency policies, and the classification, conformity assessment, and CE marking of medical devices in Europe. We participate in pricing and reimbursement proceedings, including appeals against negative recommendations by the UK’s National Institute of Health and Clinical Excellence, and have in-depth expertise in the EU chemical regime (REACH), which has a significant downstream impact on consumer and health products.

We handle regulatory matters before the European Commission, the European Medicines Agency (EMA), and national regulatory agencies in the European Union. We have actively participated in the development of key pharmaceutical legislation in Europe, and we represent clients in connection with new legislative and regulatory initiatives, including new Medical Device Regulations, Clinical Trials Regulation, Transparency Directive on pricing and reimbursement, and legislation on information to patients.

Our China regulatory team plays a significant role in the firm’s global practice. Our attorneys in Asia and the United States regularly counsel national and multinational companies on the regulatory requirements of the China FDA and provincial FDA authorities. We advise on major developments in the law, regulation, and policy-making processes, including changes to the regulatory frameworks governing food safety, medical devices, pharmaceuticals, and cosmetics, and assist with regulatory advocacy during the notice and comment process before the China FDA.