The months and weeks leading up to August recess saw an uptick in activity by Congress on Health Care Legislation, including a focus on various aspects of Food and Drug Administration (FDA) policy. As part of this bipartisan, bicameral activity, both the House and Senate advanced FDA-related bills through various stages of the legislative process. There was a recurring focus on streamlining the path to approval for generic drugs and biosimilar products, as well as expediting the development and approval of over-the-counter nonprescription drugs, themes which echo continued areas of focus by the administration. This client alert provides a high-level state of play of recent legislative actions in the House and Senate, primarily related to FDA bills in the human medical product space, and considerations for what awaits when Congress returns from August recess.

House Actions

The House Energy and Commerce Committee has jurisdiction over FDA in the House. During the week of July 20, 2026, the Committee considered and approved various FDA focused bills. These bipartisan bills included the Biosimilar Red Tape Elimination Act (H.R. 5526), the Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act (H.R. 8908) and the Expedited Access to Biosimilars Act (H.R. 9661). Of note, a new section focused on expediting the development and review of priority nonprescription drugs was added to the Lower Costs, More Transparency Act of 2026 (H.R. 9393), in the version of the bill the Committee considered and approved at markup. Also in late July, the House passed the FDA Modernization Act 3.0 (H.R. 2821) as part of a continued focus to reduce animal testing in medical product development. The House also passed the Accelerating Access to Critical Therapies (ACT) for ALS (Amyotrophic Lateral Sclerosis) Reauthorization Act of 2026 (H.R. 8205) in late July. Please see appendix for additional details.

Senate Actions

The Senate Health, Education, Labor and Pensions (HELP) Committee has jurisdiction over FDA in the Senate, and the HELP Committee also had an active stretch this summer on FDA-focused bills. On June 17, 2026, the HELP Committee approved the Biosimilar Red Tape Elimination Act (S. 1954), the Medication Affordability and Patent Integrity Act (S. 2658), the ACT for ALS Reauthorization Act (S. 4472) and the Ensuring Timely Access to Generics Act of 2025 (S. 3014). The following month, on July 22, 2026, the HELP Committee continued its focus on FDA bills through its consideration and approval of the Expedited Access to Biosimilars Act (S. 1414), Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788), Safeguarding Americans from Fraudulent and Experimental Drugs (SAFE) Act of 2026 (S. 3794) and the Insulin Act of 2026 (S. 4189), which includes biosimilar and generic drug related provisions. Notably, on August 4, 2026, the Senate passed S. 4472. Please see appendix for additional details.

What About Fiscal Year 2027 Appropriations for FDA?

In addition to authorizing committees, the House and Senate Appropriations Committees have also been focused on FDA funding fronts. On June 4, 2026, the House passed the Agriculture, Rural Development, FDA, and Related Agency Appropriations Act, 2027 (H.R. 8646). On the other side of the Capitol, the Senate Appropriations Committee has yet to move any fiscal year (FY) 2027 appropriations bills through the Committee, as Congress is simultaneously considering a Continuing Resolution (CR) to fund the federal government, including the FDA, past the end of the current fiscal year (September 30, 2026). This would also provide more time to work through the FY27 funding bills. The House and Senate have contemplated two disparate CRs, with the House bill extending FY26 funding through December 4, 2026, and the Senate bill through December 11, 2026.

What’s Next?

While there has been a flurry of activity on FDA-related bills in both the House and Senate, the path forward for advancing the bills through both chambers of Congress remains unclear against the uncertain mid-term election backdrop and subsequent lame duck session. Nonetheless, the continued bipartisan focus on FDA legislation and policy affirms that Congress remains engaged on FDA fronts and provides further insight into policy issues lawmakers may continue to lean into beyond the current Congress. This is particularly informative as Congress is set to consider the prescription drug, medical device, biosimilar and generic drug user fee reauthorizations over the next year, with the current authorizations set to expire at the end of FY 2027 (September 30, 2027). Ultimately, how these individual bills are resolved (or not) before the end of this year will further shape the legislative backdrop for the next User Fee Act (UFA) reauthorizations and related considerations for policymakers.