Project FDA spurs industry efficiency
Former FDA commissioner Andrew von Eschenbach has joined the Manhattan Institute to head up its Project FDA initiative, which aims to reduce development times for promising medical products by allowing them on the market faster under very close post-market surveillance. The initiative will look to Congress for support as it considers reform proposals as part of this year's user-fee reauthorization.
“Project FDA promotes reforms that can enable the FDA to offer a more predictable, transparent, and efficient pathway for bringing safe and effective new products to patients,” the group says.
According to the Biotechnology Industry Organization, the changes being discussed will seek to modernize the program and offer product developers the ability to use biomarkers and other measurements of a drug's effectiveness that weren't considered when the program was originated.Under von Eschenbach's leadership, Project FDA says it will educate the public on FDA's “vital” role in advancing medical innovation; highlight the potential for new sciences to improve health and lower costs; and collaborate with patient and industry stakeholders to modernize the agency's policies and procedures.