FDA’s Marks Issues ‘Provocative’ Call for Target Gene Therapy Profile That Includes Costs

Sarah Karlin-Smith

Sarah is a senior writer with Pink Sheet and has covered U.S. regulation and reimbursement policy for the biopharma industry since 2004, starting with the establishment of the Medicare Part D program. Since then, she has written extensively about developments in all major sectors of the U.S. insurance market (Medicare, Medicaid and commercial plans). She has covered key legislation affecting biopharma, including the Medicare Prescription Drug, Improvement, and Modernization Act which created Part D, health care reform under President Obama, and the Inflation Reduction Act. She has closely followed the increasing influence of pharmacy benefit managers and their use of formulary negotiations and rebates to control pricing. Cathy also has covered developments in health technology assessments and has monitored industry progress on novel drug contracting that reflects value-based pricing.