Life Sciences and Government Strategies
January 1, 2012
Legislative and regulatory matters are critically important for life sciences companies. The lawyers and policy specialists in Foley Hoag’s Government Strategies Practice have extensive experience in the development and implementation of legislation and regulations affecting the biotechnology, pharmaceutical, medical device, and healthcare provider industries. The regulatory environment can pose significant burdens to life sciences companies, but intelligent strategic advocacy on Capitol Hill and appropriate engagement of federal regulatory agencies can also provide new markets and opportunities for innovative products. Our team works directly with Congressional staff and federal agencies, including the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), on a variety of matters relating to the life sciences.
The Government Strategies Practice provides a comprehensive approach to legislative advice and advocacy. Our team has led legislative campaigns. On behalf of our individual and corporate clients, we formulate strategic initiatives, draft legislation, analyze legislative proposals, advise Members of Congress and their staffs, prepare Congressional testimony, and counsel clients for hearings. While serving as Congressional staff members, our lawyers and specialists helped craft key legislation, including the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA); the Deficit Reduction Act of 2006; the FDA Modernization Act of 1997; revisions to the Orphan Drug Act; the Biodefense and Pandemic Vaccine and Drug Development Act of 2005; and the Health Insurance Portability and Accountability Act of 1996. Drawing on our experience, our growing team has been engaged in every major piece of legislation affecting the pharmaceutical, medical device, and biotech industries over the past several years.