Congress Moves To Cap Insulin At $35/Month — Targets Patent Tactics That Delay Cheaper Drugs

The Senate Health, Education, Labor and Pensions (HELP) Committee approved the INSULIN Act on a 17-5 vote and the bill now heads to the full Senate. If passed, the measure would cap out-of-pocket insulin costs at $35 per month for privately insured patients and create a pilot program to help uninsured people access insulin at that same price. Beyond price relief, the bill includes provisions intended to limit regulatory tactics that can delay lower-cost generics and biosimilars.

What the INSULIN Act Would Do

Price Cap: The legislation would extend a $35 monthly cap on insulin to people with private insurance — equal to a Medicare cap enacted by the Inflation Reduction Act. It would also establish a pilot grant program to help uninsured patients obtain insulin at that price.

Addressing Patent And Regulatory Delays

The bill targets alleged misuse of FDA citizen petitions, which any individual or organization can file to ask the agency to take, modify, or defer an administrative action. Brand manufacturers have sometimes filed petitions shortly before a generic or biosimilar was expected to receive approval, raising issues that can slow or block market entry.

Lawmakers are also pursuing reforms to biosimilar policy. The Biosimilar Red Tape Elimination Act would remove the FDA's separate 'interchangeable' designation requirement, eliminating the need for an additional interchangeability study once biosimilarity is demonstrated — a step many other regulators, such as the European Medicines Agency, do not require.

Real-World Delays

Approved biosimilars have sometimes been kept off the U.S. market for years because of litigation settlements or layered patent protections. For example, several Humira (adalimumab) biosimilars were approved but could not enter the U.S. market until 2023 — more than six years after regulatory clearance — while Humira biosimilars reached European markets as early as 2018. Similarly, the first biosimilar referencing Enbrel (etanercept) was approved in the U.S. in 2016 but faces restrictions that will delay certain U.S. launches until 2029.

Broader Legislative Efforts

Other bills aim to shore up patent oversight and limit so-called 'patent thickets' — overlapping portfolios of related patents that can be asserted to delay competition. Examples include the bipartisan Medication Affordability and Patent Integrity Act, the Eliminating Thickets To Increase Competition (ETHIC) Act, and the Affordable Prescriptions For Patients Act. These measures would increase scrutiny of patent strategies and in some cases cap the number of related patents a company can claim or assert in litigation.

Politics, Pushback And Possible Impact

Supporters argue the reforms would lower prices and broaden access to affordable medicines. During the INSULIN Act markup, lawmakers from both parties criticized tactics they called 'gaming' of the system. Sen. Bill Cassidy (R-LA) said patents are essential for innovation but should be time-limited because abuses can unfairly extend monopolies. Critics from industry contend that weakening intellectual property protections could reduce incentives to invest in drug development.

Despite partisan divides on many issues, there is notable bipartisan concern about drug affordability: polling cited by lawmakers indicates that most voters consider prescription costs an important factor in upcoming elections, giving momentum to proposals that directly lower patient costs while also targeting practices that delay competition.

Originally published on Forbes.com.