Ahead of a Senate hearing centered on high prices for Novo Nordisk’s in-demand semaglutide medications, lawmakers are pressing the government to use its “march-in” rights and allow generic versions of the drugs to enter the market.
Sen. Elizabeth Warren, D-Massachusetts, Rep. Lloyd Doggett, D-Texas, and other legislators penned a letter (PDF) to the secretary of the Department of Health and Human Services (HHS), Xavier Becerra, urging the agency to use its authority to dole out licenses to generic semaglutide makers in order to promote competition and bring down prices.
“By utilizing your competitive licensing authority to permit generic competitors to Wegovy and Ozempic, you can stabilize supplies at a time of enormous demand and lower outrageous prices that have severely limited access to these life-changing drug,” the lawmakers wrote.
"March-in" rights were introduced as part of the Bayh-Dole Act of 1980, enabling the government to grant licenses for any patented invention that is “used or manufactured by or for the United States” under certain circumstances. The move has never been used despite numerous attempts to pressure the government into using the legal authority.
A market exclusivity period is allotted to patented products as a reward for the investments drugmakers pour into the development process. Companies often use this reasoning to justify high prices, an argument the lawmakers say has been “debunked time and time again." The lawmakers say Ozempic and Wegovy have generated more than $38 billion in combined revenue, while Novo spent $4.71 billion on R&D last year.
A clutch of advocacy groups including Public Citizen and Doctors for America made similar arguments in their own separate letter to Becerra, noting that the savings generated from generic versions of Ozempic and Wegovy could add up to more than $10 billion yearly.
The efforts come just before Novo's CEO, Lars Fruergaard Jørgensen, is set to testify at a Senate hearing on his company's pricing.
Earlier this year, the Senate Committee on Health, Education, Labor and Pensions (HELP) launched an investigation into the company’s pricing, finding that it charges $969 per month in the U.S. for Ozempic versus $155 in Canada, $122 in the company’s home country of Denmark and $59 in Germany, with similar discrepancies in Wegovy pricing.
HELP committee Chair Sen. Bernie Sanders, I-Vermont, later threatened to subpoena the company into appearing at a Sept. 24 hearing on the matter, and Novo’s CEO eventually agreed to participate.
Along with the lawmakers speaking out ahead of the hearing, Médecins Sans Frontières/Doctors Without Borders (MSF) took the opportunity to publicly call on diabetes drugmakers Novo, Sanofi and Eli Lilly to lower prices and allow generics to enter the market.
Fruergaard’s appearance at the hearing follows a separate high-profile pricing probe that saw the CEOs of Bristol Myers Squibb, Johnson & Johnson and Merck testify before a Senate committee. The U.S. Chamber of Commerce previously wrote in a statement in response to the Novo subpoena threat that Sanders was “abusing the power of his committee to intimidate companies."