In early October at the Washington Ideas Forum, FDA Commissioner Margaret Hamburg released a report containing immediate steps that the agency can take to drive biomedical innovation.
Titled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,” the report addresses concerns about the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development.
“America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public,” said Hamburg. “Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”
The “blueprint” launches the “Innovation Initiative” at FDA and identifies additional steps the agency can take immediately to address the most pressing concerns facing patients and industry.
The proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups.
The blueprint focuses on implementing the following actions:
● rebuilding FDA’s small business outreach services
● building the infrastructure to drive and support personalized medicine
● creating a rapid drug development pathway for important targeted therapies
● harnessing the potential of data mining and information sharing while protecting patient privacy
● improving consistency and clarity in the medical device review process
● training the next generation of innovators, and
● streamlining and reforming FDA regulations.