Biotech Industry Sounds Alarm on Trump Tariffs, Citing Threats to Rare Disease and Advanced Therapies
Despite billions of dollars being funneled into reshoring pharmaceutical manufacturing to U.S. soil, the biotech industry is sounding the alarm over looming tariffs proposed by former President Donald Trump, warning that the new trade measures could severely disrupt the supply chain for rare disease treatments, cell and gene therapies, and other complex biopharmaceutical products. Companies argue that the tariffs, if enacted without exemptions, could jeopardize not only the viability of U.S.-based innovation but also access to life-saving medicines for the country’s most vulnerable patient populations.
In recent weeks, dozens of biotech companies, trade associations, and patient advocacy groups have filed public comments in response to the U.S. Department of Commerce’s Section 232 investigation. This probe, initiated under the guise of national security, is evaluating whether the federal government should impose broad pharmaceutical import tariffs to reduce foreign dependency and encourage domestic drug production.
But for many in the industry, especially those focused on rare diseases and advanced therapeutic modalities, the move is being viewed as shortsighted, with potentially catastrophic consequences.
BioMarin: Tariffs Could Undermine Orphan Drug Innovation
Among the companies most vocally opposed to the proposed tariffs is BioMarin Pharmaceutical, a California-based biotech that has made a name for itself by developing treatments for rare genetic diseases. In a detailed seven-page letter submitted to the Department of Commerce, BioMarin highlighted the essential role that global supply chains play in making treatments available to underserved patients.
“With 95% of the more than 10,000 known rare diseases still lacking an FDA-approved therapy, it is in the interest of public health to preserve incentives that sustain this innovation ecosystem for rare diseases,” the company wrote.
BioMarin currently markets several advanced biologics, including Roctavian, a gene therapy for hemophilia A. While the company has recently achieved profitability, it notes that its financial stability was years in the making and was made possible largely through legislative support such as the Orphan Drug Act, which offers tax incentives and market exclusivity to developers of rare disease drugs. Tariffs, BioMarin warned, would erode those hard-won gains.
“Tariffs on these finished products and critical inputs would have an immediate and disproportionate effect on the availability and affordability of orphan drugs,” the company said. “Increased costs and supply disruptions could delay treatment development, constrain manufacturing capacity, and threaten timely access to life-saving medicines for patients who have no therapeutic alternatives.”
ARM: Tariffs Could Disrupt Patient Access to Cell and Gene Therapies
The Alliance for Regenerative Medicine (ARM), a leading advocacy organization representing companies involved in cell and gene therapy development, echoed similar concerns. ARM emphasized that many of these therapies are tailored for individual patients and manufactured in extremely small volumes—often for only a few people per year.
As such, the group argued that these treatments are highly sensitive to changes in manufacturing logistics and costs. Even minor disruptions, such as import duties on raw materials or manufacturing components, could have outsized impacts on production timelines and patient access.
“To ensure patient access, manufacturers must have confidence that they can secure ingredients from the widest possible set of reliable sources, at a predictable cost,” ARM stated. “Disrupting access to these therapies will cut off some of the most vulnerable and complex patients in our healthcare system from life-changing treatment.”
ARM proposed that if tariffs are enacted, the federal government should take a phased approach and allow small-volume imports to be exempted from duties. Such measures would allow companies time to gradually transition components of their supply chains back to the U.S., where feasible, without jeopardizing near-term treatment availability.
Rare Disease Company Coalition: Reshoring Orphan Drug Supply Chains Is Not Feasible
The Rare Disease Company Coalition (RDCC), a consortium of biotech companies dedicated to the development of orphan drugs, submitted its own comment, warning that a blanket imposition of tariffs could inadvertently cripple a sector that is already operating on tight margins and working with highly specialized manufacturing processes.
“Efforts to rapidly reshore the entire supply chain for orphan drugs, including those in development and those already approved, would be economically prohibitive,” RDCC wrote. “Orphan drug manufacturers lack economies of scale and often depend on highly specialized overseas partners for producing and packaging the final dosage form.”
RDCC includes companies such as Fulcrum Therapeutics, Sarepta Therapeutics, argenx, Inozyme Pharma, and AstraZeneca’s rare disease subsidiary, Alexion. These firms often rely on small-batch manufacturing partners located outside the U.S. that have the expertise and infrastructure to handle rare, complex biologics.
Imposing tariffs without exemptions would not only increase costs for these manufacturers but also risk creating delays in drug availability—delays that can be life-threatening for patients with ultra-rare conditions.
Complex Oncology Drugs Also at Risk
The concerns extend beyond rare diseases and regenerative therapies. Developers of complex oncology medicines are also urging the government to reconsider its approach.
Perspective Therapeutics, a U.S.-based biotech that manufactures radiopharmaceuticals used in cancer therapy, expressed concerns about potential tariffs on the specialized equipment and isotopes required for its operations. While the company has already established manufacturing sites in the United States and conducts most of its R&D domestically, its CEO Thijs Spoor argued that many of the inputs it depends on are only available from international sources.
Spoor requested that tariffs on radiopharmaceutical equipment and materials be deferred, warning that additional financial burdens could impede the company’s ability to scale its production and deliver new cancer treatments.
Similarly, Daiichi Sankyo, a Japanese pharmaceutical giant with a growing U.S. presence, pointed to the complexity of manufacturing antibody-drug conjugates (ADCs)—a cutting-edge class of cancer therapies. The company’s ADC Enhertu, developed in partnership with AstraZeneca, is manufactured across multiple continents, including the U.S., Japan, and Europe, with final packaging conducted in Ohio and distribution centered in Tennessee.
Daiichi Sankyo warned that restructuring its international supply chain to comply with potential tariff requirements would be both time-consuming and cost-prohibitive.
“Moving the overseas manufacturing steps to the U.S. would require significant overhaul of the company’s operations and substantial financial costs,” the company explained. While it is already in the process of expanding its U.S. manufacturing footprint, key production stages—including conjugation of the antibody to the drug payload—are still performed abroad.
“The application of tariffs to Enhertu and Daiichi Sankyo’s other medicines risks real consequences on the company’s ability to meet its goals for significant investment in the future of new treatments for patients and planned manufacturing capacity in the U.S.,” the company concluded.
Industry Urges Targeted Policy, Not Broad Tariffs
Taken together, the comments submitted to the federal government reflect a broad and growing consensus within the biopharmaceutical sector: while the aim of reducing foreign dependency is understandable, the means of achieving that goal must be carefully considered. Industry leaders are urging the Trump administration to adopt a targeted approach—one that accounts for the real-world complexity of biotech manufacturing and the fragility of the innovation ecosystem supporting rare diseases and advanced therapies.
From orphan drug developers to oncology innovators, the message is clear: sweeping tariffs on pharmaceutical imports could do more harm than good, threatening not only supply chains and company finances but the health of patients who depend on these medicines for survival. As policymakers weigh the results of the Section 232 investigation, the biotech sector is hoping for one thing above all—an approach that safeguards innovation without sacrificing patient access.
