WWFH Letter to Senate Committee on Health, Education, Labor and Pensions Ahead of July 22 Markup

July 22, 2026

Senate Committee on Health, Education, Labor and Pensions

428 Senate Dirksen Office Building

Washington, DC, 20510

Re: July 22 Senate HELP Committee Markup

Dear Members of the Senate Committee on Health, Education, Labor and Pensions:

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 22 markup of The CLEAR LABELS Act (S. 3788); The Expedited Access to Biosimilars Act (S. 1414); and The Ensuring Timely Access to Generics Act of 2025 (S. 3014).

As the Senate HELP Committee prepares to discuss these proposals, we urge members to carefully consider the significant and far-reaching consequences certain provisions could have for U.S. innovation, patient access, and national security. WWFH raises the following concerns regarding these three bills and their potential implications for patients, manufacturers, and the broader healthcare system.

S. 1414, 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 immunogenicity, 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.

The bill would significantly alter the FDA’s science-based framework for evaluating biosimilars by weakening the requirements for a licensure of a biosimilar while automatically granting interchangeability status - therefore undermining patient safety and restricting FDA’s ability to respond to emerging safety concerns or new scientific information.

The bill would also require FDA to determine whether certain scientific data is necessary years before a biosimilar application could be approved, limiting the agency’s ability to consider new evidence during the review process.

Congress should not substitute statutory mandates for the FDA’s scientific expertise. If changes to longstanding biosimilar policy are considered, the agency must retain the flexibility to determine, based on the totality of the evidence, whether clinical studies are necessary to support approval or interchangeability. Limiting that authority would weaken the FDA’s rigorous review process, reduce its ability to respond to evolving science and safety concerns, and risk eroding patient and provider confidence in the biosimilar marketplace. Strong, science-based safeguards remain essential to protecting patients and ensuring continued access to safe and effective medicines.

S. 3788, CLEAR LABELS Act

WWFH opposes the CLEAR LABELS Act because it would create significant market, national security, and patient access concerns without providing a clear public health benefit. The bill would require drug labels to include detailed supply chain information, including country of origin and identifying information for the manufacturers of the active pharmaceutical ingredient (API) and finished drug product, as well as the company that packages or distributes the drug. This information would include each entity’s name, place of business, and unique facility identifier, with failure to comply considered misbranding under federal law.

WWFH sees no meaningful public health benefit from this proposal and is concerned about the significant unintended consequences it could create for the market, particularly because FDA already collects this information through existing drug listing and NDA/BLA processes. The bill would not enhance FDA’s oversight capabilities or provide the agency with new data but instead would publicly disclose confidential supply chain information that could be used by competitors and purchasers to gain insight into sensitive commercial decisions and sourcing strategies.

Requiring unique facility identifiers on drug labels also raises national security and commercial concerns by publicly identifying where medicines are manufactured and potentially exposing critical supply sites to bad actors. At a time when policymakers are working to strengthen domestic pharmaceutical manufacturing, and while other countries like China are actively trying to overtake the U.S. as leader in the life sciences, public disclosure of sensitive facility information could create new security vulnerabilities for strategically important manufacturing sites. It is unclear how disclosing a facility’s precise location would provide a meaningful public health benefit, while unnecessary disruptions to the supply chain could ultimately put timely patient access to certain medicines at risk.

S.3014, Ensuring Timely Access to Generics Act of 2025

WWFH opposes the Ensuring Timely Access to Generics Act because it could unnecessarily restrict an important mechanism for stakeholders to raise scientific, safety, and regulatory concerns with FDA. The bill would amend the process for reviewing citizen petitions related to the approval of generics, biosimilars, and other drug applications by allowing FDA to summarily deny petitions if the agency determines they were submitted primarily to delay approval or do not raise valid scientific or regulatory issues. It would also add new procedural requirements for these petitions and change certain rules governing legal challenges to FDA decisions.

Citizen petitions provide an important, transparent process for stakeholders to raise scientific, safety, and public policy concerns with FDA. WWFH believes this legislation is unnecessary because FDA already has the authority and guidance needed to address petitions that are submitted primarily to delay approvals or that fail to raise valid scientific or regulatory issues. FDA’s most recent report found no evidence that 505(q) petitions were submitted with the intent to delay approvals and confirmed that no biosimilar, ANDA, or 505(b)(2) approvals were delayed as a result of these petitions. In addition, only four 505(q) petitions were submitted in FY 2023, demonstrating that the process is not being broadly abused.

Changes that could limit the use of citizen petitions may discourage legitimate scientific and safety concerns from being raised and could reduce an important avenue for stakeholder input into FDA’s decision-making process.

As the Committee prepares for this week’s 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