MassBio CEO & President Kendalle Burlin O’Connell originally shared this update on LinkedIn.
Democrats won control of both the House and Senate in Tuesday’s midterm elections, setting up a major shift in Washington’s health policy agenda when the 120th Congress convenes in January. While President Trump will retain veto power, Democratic control of key congressional committees will bring greater scrutiny of the administration’s health policies, continued pressure on pharmaceutical pricing, and shifting priorities on federal research funding and FDA oversight.
- Drug Pricing and PDUFA VIII: Senator Bernie Sanders is expected to chair the Senate HELP Committee, giving one of the pharmaceutical industry’s most vocal critics significant influence over the upcoming reauthorization of FDA’s prescription drug user fee program. Sanders is one of the few lawmakers who have opposed the premise of the user fee structure altogether, and he could use negotiations to seek broader reforms related to drug pricing and FDA oversight. In the House, Rep. Frank Pallone (D-N.J.), who chaired Energy and Commerce from 2019 to 2022, is seeking the gavel again and would lead the House side of the reauthorization. In a letter sent to colleagues, Rep. Pallone outlined an ambitious agenda focused on reversing Republican health care cuts, strengthening the Affordable Care Act, and expanding access to affordable care. He also called for expanding Medicare drug price negotiations to cover more medicines annually and extending negotiated prices to the commercial insurance market.
- FDA and NIH Oversight: Democratic majorities are expected to intensify scrutiny of HHS Secretary Robert F. Kennedy Jr.’s leadership, including changes to FDA decision-making, agency staffing, NIH grantmaking, and vaccine policy. FDA has been led by an acting commissioner since May, so any nominee for the permanent post would face confirmation before Sanders’ committee. Democrats will also have greater influence over annual appropriations, potentially strengthening congressional efforts to protect biomedical research funding and challenge political interference in scientific grant decisions.
- MFN and China Policy: Senator Ron Wyden, expected to chair Senate Finance, has already signaled that pharmaceutical CEOs will be called before his committee to answer for pricing and for what he describes as windfalls from the administration. Congressional Democrats are likely to investigate the terms of the administration’s most-favored-nation (MFN) arrangements with manufacturers, and Wyden could also pursue expansion of Medicare drug price negotiations and other affordability measures. Meanwhile, maintaining U.S. leadership in biotech will remain a bipartisan priority, and we should expect China’s rise as a global biotech power to continue to be a focus in the new Congress, with a particular eye toward how legislators respond to final Treasury COINS rules, expected by March.
- Capital Formation and SEC Oversight: Massachusetts Senator Elizabeth Warren is expected to chair the Senate Banking Committee, giving the Senator greater influence over SEC oversight and capital markets policy. Warren has been a vocal critic of SEC Chair Paul Atkins’ deregulatory agenda, including proposals intended to encourage IPOs by easing disclosure and reporting requirements. Late last week, Warren and Sen. Chris Van Hollen (D-Md.) urged the SEC to abandon four of those proposals, arguing they would weaken investor protections and undermine confidence in public markets. Her anticipated chairmanship could bring increased scrutiny of the SEC’s approach to capital formation, public listings, and private markets, with implications for emerging biotechs that depend on access to investment capital to fund research and development.
- Small Business Innovation and Access to Capital: Senator Ed Markey is expected to chair the Senate Small Business and Entrepreneurship Committee, positioning Massachusetts to play a leading role in federal small-business innovation policy. Markey worked to secure the five-year reauthorization of SBIR/STTR earlier this year as Ranking Member of the Committee and has recently challenged proposed SBA commercialization requirements that could restrict participation by certain research-intensive companies. In the House, leadership of the Small Business Committee remains unsettled following the retirement of Rep. Nydia Velázquez (D-N.Y.), with several Democrats competing for the chairmanship, including Reps. Gil Cisneros (D-CA) and Sharice Davids (D-KS) mentioned as potential successors.
