Harnessing Regulation as a Competitive Lever: Strategy at the Intersection of Market Access, Pricing and Antitrust Exposure

Once viewed as a defensive, compliance-driven function, regulatory engagement is increasingly being integrated into broader corporate strategies for long-term product protection. In the context of MFN initiatives and intensifying commercial pressures, regulatory tools are becoming an important strategic lever for shaping market access and influencing pricing dynamics, bringing regulatory activity into closer alignment with IP, competition and commercial decision-making.

Using FDA citizen petitions as a case study, this session will examine how regulatory mechanisms and lifecycle management tools can be deployed to influence market access and shape competitive dynamics, and explore how their use intersects with IP considerations, commercial positioning and antitrust enforcement risk.

- How are companies using regulatory tools, such as FDA citizen petitions, and non-patent exclusivities to complement patent strategy and support long-term product protection?
- To what extent can regulatory mechanisms and lifecycle management tools, such as new formulations and product hopping, be deployed to influence generic market entry without crossing the line into anti-competitive conduct?
- How does the timing and sequencing of regulatory interventions dictate competitive outcomes and antitrust exposure, particularly in the context of generic and biosimilar entry?
- How do regulatory strategies that influence competitive entry translate into pricing and market access dynamics, stakeholder engagement and broader commercial outcomes?

- Where can decisions around the development and launch of successor products create legal risk? 
- How are regulators, courts and competition authorities assessing and responding to the use of regulatory mechanisms and lifecycle management tools?