Regulatory Litigation

RMMS is uniquely positioned to assist our clients in negotiating the minefield of litigation, statutory, and regulatory hurdles involved in the pharmaceutical industry.

By devoting our entire practice to pharmaceutical and biologics work, RMMS has become intimately familiar not just with the legal issues facing our clients, but with the legislative, regulatory, and political hurdles as well.  RMMS attorneys have significant experience representing clients in Administrative Procedure Act (APA) actions challenging agency decisions and actions at both the district court and appellate levels. We have prevailed in regulatory actions involving FDA/HHS aimed at delaying our clients’ approvals and marketing based on unlawful claims to exclusivity or unnecessary labeling requirements.