Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Phased plan unveiled to impose up to 250% tariffs on imported pharmaceuticals
- A plan to introduce a “small” initial tariff on pharmaceutical imports was announced, followed by increases to 150% within 18 months and ultimately 250%, aiming to drive domestic drug manufacturing, reports CNBC.
- This follows a section 232 investigation started in April which allows the Secretary of Commerce to investigate the impact of imports on national security.
FDA prepares for next medical device user fee amendments (MDUFA) cycle
- The current user fee agreement under MDUFA V runs through Sept. 30, 2027, with the U.S. Food and Drug Administration having secured increased user fee funding tied to performance goals and staffing commitments in its device center, reports MedTech Dive.
- Ahead of negotiations for MDUFA VI (covering Oct. 2027 to 2032), the FDA has initiated public meetings inviting feedback on current performance and suggestions for fee adjustments amid concerns over federal budget cuts and staffing instability.
NHS to grant early access to medtech before full regulatory approval
- Digital Health reports that the UK’s National Health Service (NHS) will be able to procure innovative medical devices—particularly diagnostic technologies addressing unmet clinical needs—under a new Medicines and Healthcare products Regulatory Agency (MHRA) early access service, allowing time‑limited and conditional use before full regulatory approval is granted, with progress monitored throughout the period.
- The initiative draws on learnings from the Unmet Clinical Need Authorisation tool piloted in the Innovative Devices Access Pathway, aiming to speed adoption while balancing risk, support innovators and align with the UK’s Life Sciences Sector Plan and 10‑Year Health Plan.
FDA approves therapy for rare brain tumor
- The FDA approved the first systemic therapy for diffuse midline glioma (DMG), a type of brain tumor with a specific mutation, targeting both adults and children aged one and older who have received at least one prior therapy. Clinical trials showed tumor shrinkage in 22% of cases.
- Reuters reports that there is a goal to rapidly distribute the drug, addressing a critical gap in treatment for the estimated 3,940 U.S. patients living with DMG.
Simultaneous dual submission aims to facilitate faster approvals for medicines in the UK
- Under the new NHS 10-Year Plan, pharmaceutical companies will now be able to register their new medicines with both the MHRA and the National Institute for Health and Care Excellence simultaneously, writes Pharmaphorum.
- This joint review process aims to shave three to six months off drug approval timelines by enabling simultaneous licensing and reimbursement decisions, while also reducing administrative costs by an estimated 25%.
For more insights in life sciences, check out RSM’s industry outlook.
