Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Trump administration opens investigation into pharma-specific tariffs
- The Trump administration has launched a Section 232 national security investigation into pharmaceutical imports, focusing on drug products, active ingredients and supply chain vulnerabilities. This could lead to trade restrictions, including tariffs, according to Fierce Pharma.
- The timing of any action on this matter remains unclear.
Executive order aims to change the IRA negotiation program
- This week President Trump issued an executive order that aims to reform the Inflation Reduction Act’s drug price negotiation program; however, it is likely that significant changes will require Congressional approval, per BioSpace.
- The executive order specifically targets the IRA’s unequal treatment of small molecule drugs versus biologics, known as the “pill penalty.” Many in the industry believe the proposed changes could help restore investment in small molecule research and development if enacted through legislation.
Court blocks FDA rule on lab tests pushing issue to Congress
- A federal judge vacated the U.S. Food and Drug Administration’s attempt to regulate lab-developed tests as medical devices, citing the agency’s lack of statutory authority under existing law, according to MedTech Dive.
- While the FDA is unlikely to appeal, any future oversight may depend on Congress, though legislative action is expected to be slow.
Pharma firms ask EU for support amid tariff concerns
- Over 30 pharmaceutical companies urged the European Commission to offset high regulatory and innovation costs to keep operations in the European Union, reports Reuters.
- The push comes as U.S. tariffs loom, prompting fears of industry migration due to cheaper drug pricing and streamlined processes in the U.S.
Raleigh emerges as hub in pharma onshoring surge
- Pharma companies are investing over $10 billion in the Raleigh, N.C., region, attracted by lower costs and a highly skilled workforce, according to PharmaVoice.
- With potential U.S. tariffs on foreign drugs, firms are accelerating domestic production, positioning Raleigh as a strategic manufacturing and innovation center.
For more insights in life sciences, check out RSM’s industry outlook.
