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Practice Areas :
Food and Drug
Attorneys in the Patton Boggs Food and Drug Practice provide sound, knowledgeable, and pragmatic advice aimed at one goal – to help our clients, whether multinational corporations or start-ups, achieve their business objectives in the face of complex state, national, and global regulatory regimes. Our clients include traditional food, drug, biologics, device, and dietary supplement companies, as well as trade associations, multi-level marketing companies, advertising agencies, catalog companies, and Internet-based companies.
We address a wide spectrum of matters for our clients, whether they need advice on effective strategies to obtain approval to market a new product, assistance in determining which regulatory pathway to follow, assessment of regulatory and business risks associated with a particular strategy, help in dealing with an enforcement matter, or counsel in relation to public policy issues.
The firm counsels clients in matters related to the broad range of products regulated by federal entities, including the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC), Public Health Service, Environmental Protection Agency (EPA), U.S. Customs and Border Protection, National Institutes of Health (NIH), Drug Enforcement Administration (DEA), Consumer Product Safety Commission (CPSC), Agency for Healthcare Research and Quality, Health Resources and Services Administration, HHS Office of the Assistant Secretary for Preparedness and Response, Substance Abuse and Mental Health Services Administration, Department of Defense (DOD), Department of Homeland Security (DHS), Indian Health Service, Veterans Health Administration, and Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF).
Because our clients’ businesses are always subject to the activities of legislative bodies – including Congressional investigations, hearings, and new legislation – a substantial part of our practice involves assisting clients on public policy matters. We help clients prepare for and defend themselves in connection with Congressional oversight; we assist clients in the presentation of their views on proposed legislation; we alert clients to legislative developments that may affect their business and help them to understand the challenges and opportunities presented when new legislation is enacted; and we use the legislative process to help clients achieve their objectives, even in situations where the client issue is not, strictly speaking, a “legislative matter.”
Food and drug regulation is increasingly a global issue, and our attorneys are experienced in advising clients on global strategies. We have assisted clients in obtaining approval to market their products from Asia to Europe. We regularly advise clients on the activities of the Codex Alimentarius Commission, World Trade Organization (WTO), EU Commission, and other foreign or international organizations. We have relationships worldwide with expert consultants and counsel, and can provide effective counsel in whatever jurisdiction a problem arises.
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