MassBio CEO & President Kendalle Burlin O’Connell originally posted this update to LinkedIn.
With Congress in recess this week, the policy action shifted to the White House and the SEC — and the news on both fronts has direct implications for Massachusetts biotechs. Here’s what we’re watching.
White House releases most-favored nation pricing details: The Council of Economic Advisers published a report this week outlining the administration’s MFN drug pricing framework, including highlighting expected savings of $529 billion over the next decade. The report discusses that the Administration expects to reach similar agreements with most manufacturers in the country. We remain concerned about how MFN cascades directly into early-stage investment decisions. Massachusetts-based biotechs depend on a clear, predictable path to commercial returns to attract VC and structure partnerships with larger pharma. We’ve already witnessed an increase in caution among the investment community as a result of MFN codification efforts and are continuing to share perspectives that pursuing such legislation may ultimately weaken U.S. biotech innovation.
IRA negotiations begin showing up in Q1 earnings: Amgen and AbbVie became among the first drugmakers to publicly attribute Q1 sales declines partly to the Inflation Reduction Act’s negotiated prices, which took effect in January. Amgen’s Enbrel saw a 37% YoY decline (with multiple drivers, including 340B and competition); AbbVie’s Imbruvica dropped 25% globally, with leadership citing “IRA pricing and competitive share pressure.” Many drugs eligible for upcoming negotiation rounds were discovered or developed here in Massachusetts. We’ll be monitoring for how these IRA pricing impacts play a role in shaping innovation here and across the country.
SEC proposes optional semiannual reporting for public companies: On May 5, the SEC proposed rule amendments that would let public companies file semiannual reports on a new Form 10-S in lieu of quarterly 10-Qs. Chairman Paul Atkins framed it as restoring flexibility so companies and investors can choose the cadence that best fits their business. The public comment period runs 60 days after Federal Register publication. We’ve been expecting this proposal following recent comments by Commissioners and view this as a meaningful potential change for the dozens of public Massachusetts biotechs, particularly smaller-cap, pre-revenue companies for whom quarterly reporting is a real cost and management distraction.
Congress back in session next week: Both chambers are in recess this week. When they return, we’re already tracking a few hearings, including FDA Commissioner Marty Makary testifying before the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA on the FY2027 budget, though we expect robust discussion on growing concerns over review timelines and FDA priorities under current leadership. In addition, Senate Small Business Committee will hold a hearing, “America 250: Industrialization and the Rise of Small Manufacturers.” We’ll be monitoring for how Members discuss the growing biomanufacturing footprint in Massachusetts and across the country.