Pricing and Market Access Considerations for FDA’s Expedited Approval Programs
The FDA’s expedited approval pathways were created to enable access to therapeutic regimens for serious conditions in high unmet need areas. Experts Stephen Dunbar, Morgan Gryga, and Sabrina Ocasio outline how manufacturers can ensure long-term success by considering a product’s value proposition when pursuing FDA approval.
In an effort to encourage manufacturer innovation and aid in fulfilling unmet need for serious conditions, the FDA developed four expedited review and approval programs. These four programs are:
- Fast Track Designation
- Breakthrough Therapy Designation
- Accelerated Approval
- Priority Review
Each program expedites drug approvals for serious diseases, though each one has a different set of criteria for qualification. While these programs were created with generous intention, the associated risks and subsequent pricing and market access (P&MA) ramifications…
