MassBio CEO & President Kendalle Burlin O’Connell originally shared this update on LinkedIn.
Uncertainty at FDA. Movement on SBIR. A Congress increasingly focused on China. This week had no shortage of consequential developments for our industry.
FDA Leadership Uncertainty Continues: Last Friday, it was announced that Vinay Prasad will be departing FDA, the latest in a series of leadership changes that have deepened concerns about instability at the agency. A successor has not yet been named, though FDA Commissioner Marty Makary has committed to naming one before Prasad’s departure next month. We are watching closely how the churn at the top of FDA impacts industry — and actively sharing with Congress why predictable, science-driven regulatory oversight is essential to our work.
SBIR Reauthorization: With the House expected to take up SBIR reauthorization the week of March 16, MassBio is urging swift passage and continuing to share that SBIR is a lifeline for early-stage biotechs. Critically, uncertainty remains over whether President Trump will sign the legislation, given his signals that he won’t sign any bills until Congress first passes the SAVE Act. We’ll be watching for what happens following the anticipated passage in the House.
Congressional Hearings on China’s Pharmaceutical Industry: Recent Congressional activity has made clear that pharmaceutical supply chain security is a top-tier priority in Congress. Yesterday, the Senate Special Committee on Aging convened a hearing, “Foreign Dependence: How China Captured America’s Drug Supply”. Witnesses examined how China’s dominance in active pharmaceutical ingredients, driven by government subsidies and aggressive pricing, has created serious vulnerabilities in the U.S. drug supply. Next week, the House Select Committee on China will follow with its own hearing, “From the Science Lab to the Medicine Cabinet: How China Is Cornering the Market on Our Medicines,” scheduled for March 18. More hearings are expected soon.
Members Press Treasury to Extend Outbound Investment Restrictions to Biotech: Biotech House Foreign Affairs Committee Chairman Brian Mast sent a letter to Treasury Secretary Scott Bessent urging expansion of the Outbound Investment Security Program to cover biotechnology investments in countries of concern. Senators Cotton and Banks, and Reps. Ricketts, Moolenaar, and Crawford co-signed the letter, which warns that U.S. capital is helping to expand China’s biotechnology industry in ways that could leave the United States dangerously dependent on a strategic competitor. MassBio will continue to engage on policies that strengthen domestic biotech competitiveness and protect U.S. innovation leadership.
SEC Small Business Forum…Regulatory Reforms to Benefit Biotechs Being Considered: At the SEC Small Business Forum earlier this week, SEC Chair Atkins and Commissioners Uyeda and Peirce sent encouraging signals to the biotech community, highlighting that their 2026 focus is on crafting regulations that support small businesses and reduce red tape. On the public company side, Commissioners outlined how reforms building on the success of the JOBS Act could help smaller companies manage limited resources more effectively. Ideas on the table include allowing companies to remain on the Emerging Growth Company “on-ramp” for multiple years rather than being forced off based on arbitrary thresholds like market cap and potentially shifting to a semi-annual reporting cadence. MassBio supports efforts to reduce the diversion of capital to costly compliance.