Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for regenerative medicine firms, as well as compliance issues for manufacturers and distributors of human cells, tissues and cellular and tissue-based products (HCT/Ps). Attorneys Sally Gu, Sarah Thompson Schick, and James Huang also discussed best practices for early government engagement. The panel discussion spotlighted increasing scrutiny from the Food and Drug Administration (FDA) over regenerative medicines, and provided advice for companies operating in the space on how to avoid government enforcement actions while advocating for the Centers for Medicare & Medicaid Services (CMS) to reimburse their products.
This article is the eighth in our 2022 series, “Trends in Cell, Tissue, and Gene Therapies,” which aims to help you stay informed about the broad array of legal and regulatory issues affecting companies operating in the regenerative medicine space.
Teeing up the Summit’s discussion of best practices for early government engagement, Sally Gu, associate in the Hogan Lovells Pharmaceuticals and Biotechnology regulatory practice group, outlined the various FDA regulatory review pathways that are available to sponsors of biological products and HCT/Ps, focusing on the potential benefits and downsides to each...
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