Marks Calls For Efficient Manufacturing To Cut Gene Therapy Costs

Peter Marks, director of FDA’s biologics center, warned that the high costs of gene therapy treatments may not be sustainable in the long term for large numbers of patients in the United States, and though he acknowledged FDA can’t regulate prices, he told Inside Health Policy that the cost of developing a product could be lowered through more efficient manufacturing methods that avoid reengineering of the entire process for each application. An April report from the Institute for Clinical...