The Senate Health, Education, Labor and Pensions (HELP) Committee voted to advance two important pieces of drug affordability legislation: the Medication Affordability and Patent Integrity Act (S. 2658) and the Biosimilar Red Tape Elimination Act (S. 1954). ERIC applauds these votes. Both bills take direct aim at the anticompetitive tactics and regulatory barriers that keep lower-cost generics and biosimilars out of the hands of patients, workers, and their families.
But progress came with a setback. While the Ensuring Timely Access to Generics Act (S. 3014) was not reported out of committee, it carries an amendment on insulin price capping that ERIC strongly opposes, one that would harm rather than help patients and employer-sponsored health plans.
As ERIC President and CEO James Gelfand put it: “These three bills cut through the gamesmanship that drives up drug costs for America’s employers and workers. When it comes to biosimilars, the U.S. is woefully behind. The rest of the developed world has solved this problem. S. 1954 and S. 2658 will finally bring us in line with global standards by removing red tape that serves no medical purpose.”
However, he added, “What we cannot support is the Sanders amendment attached to S. 3014, which would cap insulin out-of-pocket costs, but force employers to pay whatever astronomical prices big pharma demands. ERIC urges Congress to separate this provision and advance S. 3014 without encumbering it with insulin pricing mandates that will ultimately hurt the very workers and families we are all trying to help.”
What the bills do
S. 2658
The Medication Affordability and Patent Integrity Act closes a critical coordination gap between the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) — a gap that drug manufacturers have exploited to extend monopolies and delay competition from generics and biosimilars. Drug companies have used this loophole to file secondary patents on characteristics already known and approved by the FDA years earlier, artificially extending market exclusivity and blocking lower-cost alternatives. The eye drug Eylea is a stark example: it faces a secondary patent that could extend exclusivity until 2040, despite its primary patent expiring in 2023. S. 2658 requires drug sponsors to certify that information submitted to each agency is complete and consistent, and it establishes a patent infringement defense when manufacturers fail to meet that obligation. CBO estimates the bill would save $115 million over ten years.
S. 1954
The Biosimilar Red Tape Elimination Act eliminates the FDA’s burdensome and unnecessary “interchangeability” designation for biosimilars, automatically deeming all FDA-approved biosimilars interchangeable with their reference products. The bill also removes exclusivity periods that have further delayed competition, while preserving the FDA’s authority to require safety studies when necessary. ERIC has long advocated for elimination of these redundant requirements, which restrict pharmacist substitution and limit competition in ways that no other developed nation imposes.
S. 3014: Where we stand
ERIC supports the core purpose of the Ensuring Timely Access to Generics Act, which expands FDA authority to deny citizen petitions filed primarily to delay approval of generic or biosimilar competitors. That reform is badly needed. What we cannot support is the Sanders amendment attached to it, which would cap insulin cost-sharing at $35 per month for participants in employer-sponsored health plans.
Let us be clear: insulin costs are outrageous, but a blunt pricing mandate is the wrong tool. This approach would shift costs onto employer plans and their employees, disrupt well-established drug formularies that group health plans use to lower overall costs, and set a troubling precedent for further government intervention in plan design — without a logical stopping point.
ERIC urges the Senate to separate the Sanders amendment from S. 3014 and instead pursue meaningful insulin affordability solutions through greater transparency requirements for manufacturers and pharmacy benefit managers.