SEAN GRIFFIN represents life science clients in disputes with state and federal agencies and in government enforcement matters. He routinely represents clients before FDA and CMS, as well as in courts around the country. Representative matters include:
- Obtaining a preliminary injunction on behalf of a trade association to prevent CMS from implementing “most favored nation” pricing for Medicare Part B drugs
- Representing a trade association in a pending lawsuit to prevent FDA from authorizing the importation of unapproved drugs from Canada
- Representing a trade association in a successful administrative action to prevent FDA from amending its “intended use” regulations
- Representing pharmaceutical manufacturers in connection with successful “section 505(q)” petitions that prevented labeling “carve-outs” proposed by generic drug manufacturers
- Representing biological product manufacturers in connection with citizen petitions regarding biosimilar labeling, the “patent dance,” and interchangeability
- Representing medical product manufacturers in disputes with FDA regarding REMS issues, Hatch-Waxman issues, orphan drugs, regulatory exclusivities, unapproved products, compounding, and other issues
- Representing medical product manufacturers in disputes with CMS regarding ASP reporting, participation in Medicaid, termination of billing privileges, and other issues
- Representing Medicare Advantage organizations in disputes with CMS regarding Star Ratings, service area expansions, risk adjustment, data validation audits, and other issues
- Defending clients in state and federal investigations and enforcement actions, including qui tam actions, often involving alleged violations of the FCA, the FDCA, the Anti-Kickback Statute, and/or state consumer protection statutes
- Generally advising clients regarding the availability of judicial review of agency action, the preservation of claims and the justiciability objections (standing, ripeness, finality, exhaustion, abstention, et) most often raised by government agencies
- In a pro bono matter, obtaining a landmark D.C. Circuit opinion limiting FDA’s enforcement discretion, see Cook v. FDA, 733 F. 3d 1 (D.C. Cir. 2013)
Sean graduated with honors from the University of Chicago Law School in 2005, where he served on the board of the Hinton Moot Court and on the staff of the MacArthur Justice Center legal clinic.