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Pink Sheet Podcast: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation

Executive Summary

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.

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

This and other podcasts are available on the Pink Sheet podcast 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.



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