MassBio CEO & President Kendalle Burlin O’Connell originally posted this update to LinkedIn.
Washington is clearing its desk before August recess. The Senate has stacked a final round of hearings, including several in the biotech space, the SEC sent Congress its annual capital formation recommendations, and the administration proposed new federal rules governing high-risk life sciences research.
Senate Schedules a Pre-Recess Run of Relevant Hearings: Before departing for August recess, the Senate will hold several hearings with a focus on the biotech industry. The Senate Finance Subcommittee on Health Care meets Tuesday, August 4 at 10:00 a.m. on Building a Resilient Health Care Future with Biotechnology, with witnesses including Alan Palkowitz of the Indiana Biosciences Research Institute, Kevin Outterson of Boston University, Vera Luther of Dartmouth Health, and NSCEB Vice Chair Michelle Rozo. The Senate Judiciary Committee follows the same morning at 10:15 a.m. with a hearing, Prescribing Sunshine: How Competition & Transparency Lowers Prescription Drug Costs, where we expect PBM practices and insurer consolidation to dominate the hearing. MassBio will be monitoring these hearings and provide a readout next week.
SEC Sends Small Business Capital Formation Recommendations to Congress: On July 27, the SEC released its report to Congress from the 45th Annual Government-Business Forum on Small Business Capital Formation, held March 9, summarizing the proceedings, the policy recommendations prioritized by participants, and the Commission’s responses. The forum’s three sessions covered early-stage capital raising, growth-stage companies and smaller funds, and small cap companies in the public markets. For biotech, the through-line was that the ability to raise capital in the public markets quickly and flexibly is a primary motivator for going public at all, given long development cycles and minimal revenue before approval. Participants pointed toward an expanded “IPO on-ramp” to widen the path for companies across stages and industries, and toward moving away from mandatory quarterly reporting so smaller companies can allocate limited resources more effectively. Chairman Atkins has framed the surrounding problem in terms of concentration: in the first seven months of 2025 roughly 40% of all venture dollars went to just ten companies, the share of deals under $5 million fell to a decade low of 49%, and thirty firms accounted for about 75% of venture dollars raised in 2024. These recommendations track closely with the comments MassBio filed on the Commission’s semiannual reporting proposal and on filer status reform, and they give Congress a concrete agenda to act on this fall.
Administration Issues Government-Wide Policy on High-Risk Life Sciences Research: On July 28, the White House released the U.S. Government Policy for Stopping High-Risk Life Sciences Research, which NIH Director Jay Bhattacharya described as establishing an explicit prohibition on dangerous gain-of-function research. The policy is a risk-based framework backed by enforcement, accountability, and transparency measures, and introduces enhanced review and reporting requirements for all life sciences research that may increase the harmful consequences of biological agents. It also imposes new international restrictions, barring life sciences research involving certain countries or entities and prohibiting high-risk work in countries lacking adequate oversight.
