
MFN and New Rules of Global Launch Sequencing
Key Takeaways
- Learn how MFN reference pricing is prompting companies to delay, skip, or concentrate launches in the U.S. market alone.
- Understand how global launch sequencing decisions interact with FDA exclusivity timelines and Europe's health technology assessment process.
Skadden's Rachel Turow explains how MFN reference-pricing exposure is changing the way companies sequence global drug launches and what's at stake for patients outside the U.S.
In this segment, Rachel Turow of Skadden explores how the expanding scope of Most Favored Nation (MFN) policy is reshaping the way pharmaceutical companies sequence global drug launches.
Turow explains that companies traditionally designed clinical programs around simultaneous global launches, but MFN reference-pricing exposure is now prompting some to delay, skip, or concentrate launches in the U.S. alone — an outcome she describes as ultimately harmful to patients outside the U.S. She also discusses how launch-sequencing decisions interact with FDA exclusivity timelines for new chemical entities, and why out-licensing deals for ex-U.S. markets have become less attractive given European antitrust rules that require separating U.S. and European pricing control.
Regulatory affairs, market access, and business development teams will gain insight into how MFN exposure is reshaping global launch strategy and licensing decisions.
