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).
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As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs
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Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity
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US FDA Asked To Tighten China Risk Control By Legislators As Markup Looms
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‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks
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US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals
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