Executive & Regulatory Advocacy

OFW has a specialized focus on CMS and FDA regulatory advocacy. Effective regulatory advocacy requires deep subject-matter expertise and an understanding of the complex administrative regulatory process. Our team includes seasoned healthcare and FDA lawyers who understand the Administrative Procedures Act (APA) and the statutory powers (and limitations) granted to CMS and FDA by Congress. Our Executive Branch advocates have a deep understanding of the regulatory process, and frequently work with CMS, FDA, HHS, OMB, the White House and Congress to effectively communicate on the various levels of the rulemaking process. We bring a unique combination of industry, regulatory, and legal expertise to the table, and partner with clients to anticipate and manage regulatory changes, navigate government approval processes, and execute advocacy strategies that advance policy objectives in rulemaking. Our experienced attorneys and advisors have worked as agency officials, attorneys, congressional staffers, managed winning political campaigns, and led successful coalitions for policy change.