Driven by constant demand from the public to develop new treatments for diseases, infirmities, and other health problems, the U.S. pharmaceutical industry has grown into one of the most innovative economic sectors in the world.  Over the last decade, the industry has progressed tremendously, with the emergence of new drugs and treatment methods leading to revolutionary advances in the prevention or cure of many human and animal illnesses. The industry is also a vital economic force – in 2004, for example, major pharmaceutical companies spent nearly $40 billion toward the research and discovery of new medicines, while Americans alone spent hundreds of billions of dollars on both prescription drugs and over-the-counter medicines and treatments.

Although the pharmaceutical industry remains robust, its well-being is continually challenged by government and consumer demands.  The industry is heavily regulated and monitored by federal entities, imposing a burden that increases both costs and lead times for important drugs and treatments.  At the same time, the industry faces conflicting pressure from consumer advocates to make pharmaceuticals more affordable, or in some cases, to provide drugs free-of-charge.  Pharmaceutical companies must also guard against the constant threat of intellectual property loss and consumer-driven litigation.

Patton Boggs assists members of the pharmaceutical industry in meeting the many challenges of today’s market. Our clients include traditional food, drug, device, and dietary supplement companies, as well as trade associations, multi-level marketing companies, advertisers, and Internet-based companies.  We counsel clients in matters related to the broad range of products regulated by federal entities, including:

• the Food and Drug Administration
• the U.S. Department of Agriculture
• the Federal Trade Commission
• the Environmental Protection Agency
• the Bureau of Alcohol, Tobacco, and Firearms
• the U.S. Customs and Border Patrol
• the Drug Enforcement Administration
• the Consumer Product Safety Commission
• the Centers for Medicare and Medicaid Services

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 also regularly advise clients on global regulatory regimes, such as the activities of the Codex Alimentarius Commission, World Trade Organization, EU Commission, and other foreign or international organizations.