MassBio CEO & President Kendalle Burlin O’Connell originally posted this update to LinkedIn:
This week, MassBio hosted our 2026 Align Summit, where policy and regulatory leaders joined industry stakeholders to discuss how shifting priorities in Washington could shape the future of American innovation. While we were at the Conference, we kept an eye on several key policy developments in Washington, including a new FDA initiative focused on rare disease drug development and Treasury’s proposed COINS rule moving through review ahead of its public release, and today we submitted our comments on PDUFA VIII reauthorization.
MassBio Hosts 2026 Align Summit: MassBio convened investors, pharma leaders, policy and regulatory experts, and emerging company executives in Boston on October 15 for our annual Align Summit. With policy and regulatory priorities in Washington shifting quickly, the program focused on what these changes mean for the industry, including a regulatory panel featuring key leaders from the Administration and an outlook on how federal developments could affect capital formation, drug development, and research funding. In addition, more than 50 pre-seed to Series B startups presented to investors and pharma partners, building the connections that will help fuel the next wave of Massachusetts innovation. Thank you to everyone who joined us and helped make this year’s summit a success.
MassBio Submits Comments on PDUFA VIII Reauthorization: On October 16, MassBio submitted comments to FDA on its proposed recommendations for reauthorizing the Prescription Drug User Fee Act for fiscal years 2028 through 2032. We strongly support timely reauthorization and welcomed commitments to strengthen communication between FDA and sponsors and make review more predictable, including a new process for clarifying meeting minutes and earlier feedback on pivotal protocols. Our comments focused on making sure these benefits reach sponsors of every size, especially the small companies that make up 80 percent of our biopharma membership. We supported the proposed 50 percent fee reduction for applications with U.S.-anchored Phase 1 data while noting that regulatory speed and predictability weigh more heavily in where companies start trials. We also urged FDA and Congress to evaluate proposed changes to the orphan drug fee exception before they are finalized, and recommended FDA pilot a dedicated navigation service to help first-time sponsors through the IND process. MassBio will continue to engage with FDA and Congress as reauthorization moves forward.
FDA Launches Rare Disease Framework Initiative: On October 14, FDA announced a Rare Disease Framework Initiative to reshape how drugs and biologics for rare diseases are developed and reviewed. The initiative aims to establish an approach tailored to the unique challenges of developing rare disease therapies, accounting for specific disease characteristics, patient needs, product type, and the evidence that can be generated in small populations. The FDA’s stated priorities include more consistent and predictable decision-making, earlier and more structured patient input, risk-based approaches to manufacturing review and pre-approval inspections, and greater use of novel methods and statistical approaches. FDA is expected to host roundtables and post Requests for Information in the coming months on how to ensure success for the program. MassBio will continue to closely monitor the initiative and engage with FDA as the framework moves forward.
Treasury Outbound Investment Rule Moves to White House Review: On October 9, Treasury sent its proposed rule implementing the COINS Act to the White House Office of Management and Budget for review, a key step before the rule is published for public comment. Treasury must finalize the regulations by March 13, 2027. While biotechnology is not currently covered by COINS, Treasury has the authority to add it under covered sectors, and several members of Congress have urged the agency to do so. MassBio will continue tracking the rule and share updates once it is public, while advocating for domestic policies that keep the U.S. the best place in the world to develop new medicine.
