Industrial Policy & Trade Monitor· 2662 actions· ✨ 89 recent

On 2 April 2026 President Trump issued a Presidential Proclamation under Section 232 of the Trade Expansion Act of 1962 ("Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States") imposing a 100% ad valorem tariff on imports of patented pharmaceutical products listed in the FDA Orange Book and Purple Book, together with the active pharmaceutical ingredients (APIs) and key starting materials used to make them. The base rate takes effect at 12:01 a.m. EDT on 31 July 2026 for the 17 manufacturers identified in Annex III, and on 29 September 2026 for all other companies. The proclamation adopts findings of the Section 232 investigation initiated by the Department of Commerce on 14 April 2025 into pharmaceuticals and APIs as a national- security supply-chain risk. The instrument is structured around a multi-tier rate ladder rather than a flat tariff: concessionary 15% rates for EU/Japan/South Korea/Switzerland/Liechtenstein under reciprocal-deal tracks, 10% for the UK with a pathway to 0% under the pending UK pharmaceutical agreement, a "+20%" surcharge for companies operating under a Commerce-approved onshoring plan (until 2 April 2030), and a 0% pathway for companies that combine an approved onshoring plan with an MFN-pricing agreement with HHS (until 20 January 2029). Generics, biosimilars and their ingredients, orphan drugs, nuclear medicines, plasma-derived therapies, fertility treatments, and cell/gene therapies are carved out.

Section 851 of the FY 2026 National Defense Authorization Act (P.L. 119-60), signed December 18, 2025, prohibits US federal agencies from procuring biotechnology equipment or services from designated "biotechnology companies of concern" (BCCs), and bars federal contractors from using such equipment/services in work performed under federal contracts, grants, or loans. The final enacted text ties initial BCC designations to DoD's existing §1260H Chinese-military-company list (which currently includes BGI and MGI, but not WuXi AppTec or WuXi Biologics) and directs OMB to designate additional BCCs within one year of enactment; operational prohibitions activate 60-90 days after FAR revision, with a five-year grandfather period for pre-existing contracts — enforcement is expected to begin in 2027-28. The legislation is the successor to H.R.8333 (118th Congress, House-passed September 2024 but stalled in the Senate before adjournment) and represents the first enacted US federal-procurement biotech-supply-chain-resilience statute.

On 13 August 2025 President Trump signed an Executive Order ("Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve", Federal Register Doc. 2025-15823, published 19 August 2025) directing the HHS Assistant Secretary for Preparedness and Response (ASPR) to refill and operationalise the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). Within 30 days, ASPR must compile an initial list of 26 essential drugs, account for available funding, and acquire and maintain a six-month supply of the corresponding APIs. Within 90 days, ASPR must deliver an expanded list of up to 86 essential medicines and medical countermeasures plus a plan to source those APIs from domestic manufacturers, and within 120 days (subject to appropriations) ready the existing SAPIR repository and submit a proposal and cost estimate for opening a second repository. The order prioritises domestically manufactured APIs in federal procurement and reserve build-out and directs interagency coordination across HHS/ASPR, FDA, DoD (Industrial Base Fund / Defense Production Act Title III), and the Department of Commerce.

President Trump signed Executive Order 14273, "Delivering Most- Favored-Nation Prescription Drug Pricing to American Patients", on 12 May 2025. The EO directs HHS, USTR, and Commerce to pursue mechanisms (negotiation targets, importation pathways, and trade-policy levers) to bring the prices Americans pay for innovative prescription drugs into alignment with the *lowest* prices paid by other comparably-developed nations — the "most-favored-nation" (MFN) benchmark. Unlike the Biden-era Inflation Reduction Act drug-price-negotiation provisions (which apply to a handful of Medicare Part D drugs), the EO applies pressure across the broader pharmaceutical pricing surface. As of April 2026, 17 major pharmaceutical manufacturers (incl. Eli Lilly, Pfizer, Bristol-Myers Squibb, AbbVie, Merck, AstraZeneca, Regeneron) have signed bilateral agreements bringing US drug prices toward the international- benchmark level for selected medications.

On 16 January 2025 the US Bureau of Industry and Security published an interim final rule (90 FR 4598; FR Doc 2025-00723) creating new ECCN 3A069 for high-parameter flow cytometers and liquid chromatography mass spectrometers specially designed for top-down proteomics, plus new ECCN 3E069 for related development and production technology. Items previously controlled under the catch-all ECCN 3A999 are migrated into the dedicated 3A069 classification, which carries National Security (NS), Regional Stability (RS), and Anti-Terrorism (AT) controls. Licensing policy is presumption of denial for destinations in Country Group D:1 and D:5, Macau, and Country Group E (i.e. China, Russia, Iran, North Korea, Cuba, Syria, Venezuela). The rule also adds new EEI/AES filing requirements (§ 758.1(b)(11)) for all 3A069 exports to Country Group D destinations. Public comments were accepted until 17 March 2025.

On 23 December 2024 the US Bureau of Industry and Security published a final rule (89 FR 104408; FR Doc 2024-30425; RIN 0694-AJ83) amending the Export Administration Regulations to implement decisions adopted at the Australia Group's 2023 and 2024 plenary meetings. The rule adds new ECCN 2B352.k controlling instruments for the automated chemical synthesis of peptides that are partly or entirely automated and capable of generating peptides at a system-synthesis scale of 1 mmol or greater, finalising the April 2023 BIS proposed rule. It also adds dipropylamine to ECCN 1C350.d.11, neosaxitoxin to ECCN 1C351.d.12, revises the 1C351.d.3 entry from "botulinum toxins" to "botulinum neurotoxins" to capture all serotypes, adds a "minimum detection limit" definition for toxic-gas monitors in 2B351.a, and explicitly captures single-use centrifugal separators in 2B352.c. License requirements (CB, AT, CW where applicable) apply for export to non-Australia-Group destinations; the rule is effective on publication.

The US Bureau of Industry and Security issued a final rule on 5 September 2024 (effective 6 September 2024, published in the Federal Register on the same day as 89 FR 73285) establishing multilateral export controls on four categories of emerging technologies: (1) quantum computing items including quantum computers, related cryogenic / control / measurement systems, and certain quantum software; (2) gate-all-around field-effect transistor (GAAFET) production technology — the next-node semiconductor architecture beyond FinFET; (3) advanced additive-manufacturing equipment for metals + alloys; (4) certain biotech-related items added in a parallel rule on 12 September 2024. The rule operates without country exceptions for some categories, with multilateral coordination via Wassenaar + Australia Group + Nuclear Suppliers Group frameworks.