Company statement

Novo Nordisk files lawsuit to protect patient access challenging the Inflation Reduction Act’s drug pricing scheme as unconstitutional and the Centers for Medicare and Medicaid Services’ actions as unlawful

• As drafted and implemented the IRA harms patients by limiting access to life saving medicines and depressing needed innovation for chronic diseases
• Novo Nordisk supports policies that seek to ensure medicines are affordable for patients and help increase access for those in need

PLAINSBORO, N.J., September 29, 2023 – Novo Nordisk announced today that it has filed a lawsuit against the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) related to the drug pricing provisions of the Inflation Reduction Act (IRA), which subject the company’s medicines to unconstitutional government-imposed price controls by ignoring or disallowing provisions and processes required by law, arbitrarily limit the submission of information needed to ensure prices are fair and appropriate, and unlawfully oversteps the agency’s authority.

With the implementation of the IRA, Novo Nordisk asserts that price negotiations violate several constitutional rights, including both the Fifth and First Amendments.

CMS also directly violated the law by, among other things, selecting more than 10 individual drugs for price controls by grouping together products with the same active ingredient or moiety. The IRA does not permit CMS to treat multiple products, such as Novo Nordisk’s novel insulin aspart products, including NovoLog ^® (insulin aspart injection) and Fiasp ^® (insulin aspart injection) as one. These medications are different drugs with different formulations and different requirements for approval, each separately licensed by the US Food and Drug Administration (FDA). Each medicine had its own development timeline, clinical trial program, and production cost. By treating these products as one, CMS is defying the IRA’s clear and express mandates and setting up conflicts with the FDA’s longstanding regulatory definitions and programs.

“Not only are pricing provisions of the IRA unconstitutional, CMS has overstepped its authority and taken aggressive and unlawful steps that harm patients living with chronic disease,” said Steve Benz, Corporate Vice President, Legal and General Counsel at Novo Nordisk. “We believe the IRA’s pricing scheme will limit patient access and negatively affect overall patient care. Novo Nordisk is challenging this law to protect patients and ensure our ability to continue developing and providing transformative medicines to treat and cure chronic diseases now and in the future.”

For more than 100 years, Novo Nordisk has been devoted to addressing the unmet medical needs of people living with serious chronic diseases by discovering innovative medicines and delivery systems. This includes the company’s long-standing commitment to affordability in the US and the company remains steadfast in ensuring people living with diabetes can afford the insulins on which they rely.

Novo Nordisk previously announced in March that the Company is lowering the US list price of NovoLog^® by 75%, effective January 1, 2024. Novo Nordisk also continues to offer several other affordability programs that can be accessed by eligible patients directly at NovoCare.com. 

About NovoLog^®

NovoLog^® is a rapid-acting insulin that helps lower mealtime blood sugar spikes in adults and children with diabetes. It has been proven to help control high blood sugar in people with diabetes when taken with a long-acting insulin. For additional information about NovoLog^®, please see the full prescribing information here .

About Fiasp^®

Fiasp^® is a rapid-acting insulin indicated to improve glycemic control in adult and pediatric patients with diabetes. For additional information about Fiasp^®, please see the full prescribing information here .

About Novo Nordisk

Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity and rare blood and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in seven states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk-us.com ,  Facebook ,  Instagram , and  Twitter .

         

NovoLog^® is a registered trademark of Novo Nordisk A/S.
Fiasp^® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
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