Amid Medicare negotiation battle, lawmakers push for answers on insulin prices and patent reform

It was a year ago this month that President Joe Biden signed the Inflation Reduction Act. While the landmark bill introduces several pricing measures, Democrats on Capitol Hill are still pursuing ways to rein in the pharma industry.

On Thursday, Senators Maggie Hassan (D-N.H.) and Tina Smith (D-Minn.) pressed insulin makers Eli Lilly, Novo Nordisk and Sanofi on their eligibility criteria for inexpensive insulin that the companies have pledged to provide later this year.

Additionally, Rep. Pramila Jayapal (D-Wash.) and Sen. Elizabeth Warren (D-Mass.) have asked the FDA to address “sham patents” that biopharma companies acquire to “hold off generic competition for at least 2.5 years, regardless of the outcome of any litigation.”

In a letter (PDF) to FDA Commissioner Robert Callif, the lawmakers specifically highlighted the FDA’s practice of delaying generic reviews for 2.5 years if a brand-name company sues the competitor for infringement.

The lawmakers are urging the FDA to clarify guidelines for patents that can be listed in the regulator’s Orange Book—the registry for patents of approved drugs.

They also want the FDA and the U.S. Patent Office to develop a validation system for patents and to enact other measures that would allow easier access to the market for generics and biosimilars.

As for Hassan and Smith’s effort with the insulin manufacturers, they want answers by Sept. 15 on the sign-up procedure for users and whether income level or insurance status will affect eligibility.

Earlier this year—at the urging of Biden and Sen. Bernie Sanders (I-Vt.)—Lilly, Novo and Sanofi said they would cap the monthly price of insulin at $35. The companies have not addressed barriers that might exist for diabetes patients to access the treatment.

Sanofi said in an email that it would respond to the letter and cited its March 16 announcement on dropping the price of insulin.

“As shown by our longstanding and extensive efforts to expand access and affordability for people living with diabetes, Sanofi supports actions taken to lower costs for patients,” a company spokesperson wrote. 

The lawmakers said that they questioned the three companies on their insulin plans back in May but got no “concrete response.”

The letters come in the same week that the Centers for Medicare & Medicaid Services revealed the first 10 drugs set to face Medicare price negotiations under the Inflation Reduction Act. While the law states that negotiated prices on the blockbuster drugs are set to go into effect on January 1, 2026, the industry is fiercely fighting the negotiating system in court. 

At least half a dozen drug companies have challenged IRA with lawsuits, and the U.S. Chamber of Commerce has also gotten involved with its own litigation.

In response to the CMS' list earlier this week, Stephen Ubl, president and CEO of industry trade group PhRMA, criticized the "rushed process" that he says is "focused on short-term political gain rather than what is best for patients.” But it remains to be seen whether the industry objections can bring any changes to the law.