September 25, 2024

Chairman Sanders, Ranking Member Cassidy, and Members of the Senate HELP Committee,

Consumer Action for a Strong Economy (CASE) writes today to represent the interests of millions of U.S. consumers before your committee to raise serious concerns about the Biosimilar Red Tape Elimination Act.

While CASE appreciates honest efforts to rein in the excessive federal bureaucracy and red tape that too often strangles our economy, these steps should not cut corners on basic consumer protections. This bill would do just that, as outlined in CASE’s recent op-ed on the proposed legislation.

Specifically, the Biosimilar Red Tape Elimination Act eliminates the current system we have in place for determining whether a biosimilar pharmaceutical product can be licensed as an interchangeable biosimilar for reference products. The proper checks allow the U.S. Food and Drug Administration (FDA) to flag risks for threats like immune reactions and confirm that the biosimilar in question would work as effectively as the substituted product. However, the bill would remove the FDA’s risk determination and simply grant all biosimilars licenses to be used as substitutes for patients.

What’s more, this legislation ignores the primary factors impacting healthcare costs and access. The bill does nothing to take on the largest Pharmacy Benefit Managers (PBMs) that use their market share to drive up prices and increase their own profits. PBMs collect nearly $200 billion annually from negotiated rebates and, because of this, have little reason to promote cheaper options on formularies. The higher the list price, the larger the rebates middlemen can squeeze out of manufacturers.

This means that low-cost biosimilars are often blocked from formularies, solely to benefit PBMs’ bottom lines. And to gain even more control over the market, the largest PBMs are now creating their own lines of biosimilars. The proposed legislation would clear the way for PBMs to force their own products on consumers by eliminating the need for FDA interchangeability designations. Members of the Senate HELP Committee must consider the unintended consequences of this legislation.

We urge you to reject this bill and refocus your attention on the actual issues plaguing our healthcare system today.