S. 5043: Secure Drug Supply Chain Act of 2026

This bill would direct the Food and Drug Administration and the Department of Health and Human Services to take stronger steps to block counterfeit, unapproved, misbranded, or adulterated drugs and drug ingredients from entering the United States, with a particular focus on products from China and other countries the Secretary of State designates as adversarial.

What the bill would do

• Require federal agencies to use existing drug-law authorities to stop the import of questionable drugs, including active pharmaceutical ingredients and “key starting materials” used to make drugs.
• Increase enforcement against foreign manufacturers, importers, and other entities involved in the drug supply chain if they are handling unlawful drug products.
• Allow the government to refuse entry to covered products and, in some cases, order destruction of refused goods that pose significant public health concerns, without allowing them to be exported first.
• Expand the list of circumstances under which a foreign drug establishment can be barred from registration if it knowingly used forced labor or violated U.S. sanctions.
• Add new prohibited acts and labeling/misbranding rules for false or fraudulent statements tied to imported drugs.

More reporting and transparency

The bill would require drug manufacturers and other registrants to report more detailed supply-chain information, and to do so quarterly instead of annually. The new reporting would cover, for certain drugs, the identity, quantity, and country of origin of active ingredients, key starting materials, and certain intermediate materials.

For the first year after the new rules take effect, this added reporting would apply to drugs on the FDA’s Essential Medicines List that rely on ingredients or materials sourced from China or another foreign country of concern. After that first year, the reporting would apply more broadly to drugs with ingredients or materials sourced from China or another foreign country of concern.

Companies would have to keep supporting records for at least five years and make them available to the Secretary upon request.

New reports to Congress

• The Secretary of Health and Human Services would have to send annual reports to Congress on enforcement actions taken against unlawful imports.
• The Secretary would also have to submit a confidential report analyzing U.S. dependence on pharmaceutical ingredients and starting materials from China and other foreign countries of concern, identifying supply-chain vulnerabilities and trends over time.
• Within 180 days of enactment, HHS would have to report on current legal tools that could encourage sourcing from other countries, and on gaps in existing authority.

New regulations and guidance

• HHS would have to issue proposed regulations within 90 days and finalize them later under set deadlines.
• HHS would also have to issue guidance defining the term “key starting material,” since that term is used throughout the bill.

Relevant Companies

• PFE — Pfizer could be affected if it relies on imported active ingredients or intermediate materials that fall under the bill’s new reporting, inspection, or sourcing requirements.
• MRK — Merck could face added supply-chain documentation and compliance obligations for covered drug inputs sourced from foreign countries of concern.
• BMY — Bristol Myers Squibb could be impacted by tighter import controls and reporting rules for drug ingredients and manufacturing inputs.
• JNJ — Johnson & Johnson could see compliance effects if any of its pharmaceutical products or inputs are sourced through affected supply chains.
• LLY — Eli Lilly could be directly affected if ingredients or key starting materials in its drug manufacturing supply chain are subject to the new sourcing and disclosure rules.
• SNY — Sanofi could be affected in its U.S. drug operations if imported ingredients or finished products are subject to the new import restrictions.
• NVO — Novo Nordisk could face added scrutiny or compliance costs for imported drug inputs used in products sold in the U.S.
• TEVA — Teva, a large generic-drug manufacturer, could be affected if its supply chains depend on foreign-sourced ingredients or manufacturing facilities covered by the bill.
• VTRS — Viatris could be impacted by the bill’s expanded import oversight and reporting requirements for generic and branded drug supply chains.