Morgan Lewis

Biologicals and Drugs Selected Representations

  • Represented pharmaceutical manufacturers regarding FDA, healthcare regulation, antitrust and state regulatory requirements relating to drug pricing, distribution and promotion programs.
  • Litigated market exclusivity issues for a major pharmaceutical manufacturer concerning FDA approval of a generic version of its product.
  • Negotiated a multistate consent settlement and related FDA enforcement action involving the promotion of prescription drugs and provision of pharmacists’ information services.
  • Successfully represented a major pharmaceutical manufacturer in switching a combination drug from prescription to over-the-counter.