In a letter to the Department of Commerce, Novo Nordisk argued that unsanctioned compounded semaglutide, mostly from China, constitutes a national security threat to the U.S.
Novo Nordisk “strongly” urged the Department of Commerce not to impose tariffs on pharmaceutical products, citing the potential disruptions such a move could have on access to crucial medications.
The Danish pharma made these assertions in a letter to the federal agency dated May 6, submitted as part of the Commerce Department’s request for comments regarding its Section 232 national security probe into pharma imports. Instead of a blanket levy across all imports, Novo instead is asking the department “to focus its investigation on imported semaglutide [the active pharmaceutical ingredient in its Wegovy and Ozempic] from unauthorized sources to determine whether these illegal imports constitute a threat to national security.”
In particular, Novo points the finger at “unauthorized semaglutide from China,” imports the company claims “impede investments in the United States and constitute a threat to national security.” The FDA, Novo added, does not have sufficient oversight over the manufacturers of these Chinese semaglutide knockoffs that are exported into the U.S. and made available to patients through compounded drugs.
China’s own regulators, Novo claimed, have “insufficient” oversight over these producers—of the 19 documented companies that delivered semaglutide compounds into the U.S., 12 “are considered not in compliance with [Good Manufacturing Practice] for semaglutide manufacturing.”
Novo is urging the Commerce Department to focus its efforts on such imports while securing a robust pharma supply chain with “our European allies.” The pharma stated in its letter that “much” of its products are developed, filled and packaged in the U.S., but that a substantial portion of its manufacturing still takes place in Europe.
“All semaglutide API imported into the U.S. comes from our manufacturing site in Denmark,” Novo wrote. Tariffs and other policy moves to restrict the flow of products through these “approved channels” could not only threaten the company’s U.S. investments and capacity, but also affect patient access to medicines, the company argued.
“Protecting the integrity of our supply chain is crucial to ensuring that Americans continue to benefit from our high-quality pharmaceutical products without interruption,” the letter continues.
Novo joins a growing list of Big Pharma players that in recent weeks have spoken out against the steps taken by President Donald Trump in a purported effort to lower drug costs in the U.S. Amgen, for instance, argued earlier this month that instead of imposing tariffs, the government should boost domestic manufacturing through a pro-growth tax policy.
Much of pharma’s opposition, however, has focused on Trump’s Most Favored Nation drug pricing executive order, which seeks to bring down drug prices in line with those of other similarly developed countries.
Takeda’s U.S. president Julie Kim earlier this month called this “a price control,” noting that it could have “an industry impact over 10 years of up to 1 trillion dollars.” Last month, AbbVie noted that such price controls could “harm” the “U.S. healthcare industry and future innovation.”
