Biotech Leaders Urge FDA to ‘Modernise’ Regulation to Compete with China

On June 5, 2025, the FDA hosted a roundtable focused on the regulation of cell and gene therapies, with participation from top biotech leaders and policymakers25.

A central concern voiced at the roundtable was the need to speed up the regulatory process for new, innovative therapies to prevent the U.S. from falling behind China in biotech innovation and competitiveness2.

Attendees, including FDA and HHS officials, discussed eliminating outdated or burdensome regulations and called for streamlining approval pathways to accelerate patient access to novel treatments2.

The roundtable was attended by high-level government appointees such as FDA Commissioner Martin Makary, NIH Director Jay Bhattacharya, and CMS Administrator Mehmet Oz, all under President Trump's second term2.

Leadership at the meeting pledged that the FDA would act based on input from industry stakeholders to modernize regulations and better support rapid biotech innovation2.

Sources:

2. https://www.fiercebiotech.com/biotech/fda-cell-and-gene-roundtable-makary-rfk

5. https://www.politico.com/newsletters/prescription-pulse/2025/06/03/fdas-early-ai-debut-sparks-questions-00381781