WWFH Letter to House Committee on Energy & Commerce Ahead of July 20 Markup

July 20, 2026

House Committee on Energy and Commerce

2125 Rayburn House Office Building

Washington, D.C. 20515

Re: July 20 House E&C Committee Markup

Dear Members of the House Committee on Energy and Commerce:

On behalf of We Work For Health (WWFH), a coalition of national and local business leaders, labor organizations, biopharmaceutical companies, patient advocates and other healthcare stakeholders united in support of policies that foster innovation and facilitate the delivery of cutting-edge medicines, we appreciate the opportunity to provide comments ahead of the July 20 markup considering The Expedited Access to Biosimilars Act (H.R. 9661) and The STOP GAMES Act of 2026 (H.R. 8908).

As the House E&C Committee prepares to discuss these proposals, we respectfully urge members to carefully evaluate the significant and far-reaching consequences certain provisions could have for U.S. innovation, patient access to care, and our nation’s long-term competitiveness and security. While we appreciate the Committee's efforts to address critical healthcare challenges, WWFH is concerned that certain aspects of these bills could produce unintended consequences for patients, manufacturers, and the broader healthcare ecosystem. We therefore offer the following comments on the two bills and their potential impact on healthcare stakeholders and the innovation pipeline that supports future medical advances.

H.R. 9661, Expedited Access to Biosimilars Act

WWFH opposes the Expedited Access to Biosimilars Act because it could undermine FDA’s ability to make science-based decisions that protect patients while maintaining confidence in the biosimilar approval pathway. The bill would fundamentally change the current biosimilar approval process by shifting the burden to FDA to justify when clinical studies assessing pharmacodynamics, or comparative efficacy are necessary. This approach could create uncertainty around when these important assessments are appropriate and limit FDA’s ability to evaluate each product based on its unique characteristics.

Rather than the sponsor demonstrating that immunogenicity, pharmacodynamics, or comparative efficacy studies are unnecessary for a given product, the bill would place the burden on FDA to affirmatively justify requiring them. This inverts a standard that has governed biosimilar review since the pathway's creation, and it raises real questions about whether the agency will retain the flexibility to tailor its evidentiary requirements to the specific product in front of it.

This concern is compounded when H.R. 9661 is read alongside the Biosimilar Red Tape Elimination Act. If both measures move forward together, a biosimilar could reach the market under a lighter evidentiary standard and simultaneously be deemed automatically interchangeable — meaning it could be substituted for the reference product at the pharmacy counter without a separate determination. Layering these two changes at once leaves less room for FDA to course-correct if a safety signal emerges after approval.

We are also concerned that the bill would ask FDA to commit, years in advance of any specific application, to whether certain categories of clinical data will be required — a determination made before the agency has any of the product-specific evidence in front of it.

Should Congress move forward with changes in this area, we urge that FDA be directed to publish clear, transparent, and scientifically grounded criteria governing when the additional studies remain necessary, so that the standard is predictable and publicly accountable rather than decided informally on a case-by-case basis. WWFH has historically supported efforts to increase accessibility to biosimilars, as they are critical in lowering healthcare costs and promoting patient accessibility. However, the legislation as proposed would undermine necessary steps for accountability and protecting patient safety.

H.R. 8908, STOP GAMES Act of 2026

WWFH is deeply concerned that H.R. 8908 would narrow a longstanding and legally protected channel, the citizen petition process, for raising legitimate scientific, safety, and regulatory questions with FDA. The bill would give FDA authority to summarily deny a Section 505(q) petition when it determines the petition was filed primarily to delay a generic, biosimilar, or 505(b)(2) approval, or that it fails to raise a genuine scientific or regulatory issue, and would layer on new procedural requirements and altered judicial review provisions.

However, this legislation would grant FDA authority it already possesses. Under its 2019 guidance, the agency can summarily deny petitions it determines were filed primarily to delay and that lack scientific or regulatory merit. Moreover, the available evidence does not suggest that abuse of the petition process is a widespread problem requiring a legislative remedy. In its most recent Section 505(q) report, FDA found no petitions filed with a primary purpose of delay and confirmed that no ANDA, biosimilar, or 505(b)(2) approval was actually delayed by a petition. The report also noted that only four petitions were filed under this provision in fiscal year 2023, a volume that does not support the claims that the process is being widely exploited. As a result, the proposed changes appear to address a problem that FDA already has the tools to manage and that available data indicate is exceedingly rare.

Restricting this pathway risks discouraging the legitimate use of citizen petitions to flag real safety and scientific concerns, and narrowing an important channel for public input into FDA's decision-making.

As the Committee prepares for this markup, WWFH urges members to pursue policies that expand patient access while preserving the scientific standards, innovation incentives, and supply chain stability necessary to deliver safe and effective medicines.

Thank you for your attention to this matter.

Sincerely,

Dan LeonardExecutive DirectorWe Work For Health

www.weworkforhealth.org