Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Interim Editor in Chief Nielsen Hobbs discuss the implications of the BIOSECURE Act on the pharma industry in the US and China now that the bill that would restrict US government contracting with “biotechnology companies of concern,” as well as the other companies that contract with them, has cleared the House Oversight and Accountability Committee (:30). They also consider some in industry pleading for tougher US Food and Drug Administration enforcement of clinical trial diversity regulations (22:26), as well as the agency’s use of platform technology designation principles for products that do not qualify for the designation (33:07).
More On These Topics From The Pink Sheet
- As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs
- BIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern’
- Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity
- US FDA Asked To Tighten China Risk Control By Legislators As Markup Looms
- ‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks
- US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals
This and other podcasts are available on the Pink Sheetpodcast page, as well as the Citeline channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.
