In response to concerns about the sustainability of US drug-development efforts, FDA has released a report, titled Driving Biomedical Innovation: Initiatives to Improve Products for Patients. The report outlines several steps that FDA will take to spur biomedical innovation and ensure that such innovation can be quickly translated into safe and effective therapies. Input used to compile the report was obtained from a broad spectrum of stakeholders, including members of large pharmaceutical companies, small biotech companies, academic researchers, and patient advocacy groups.
The report outlines major areas in which FDA will be launching initiatives to address feedback obtained from stakeholders. They include:
- Rebuilding FDA’s small business outreach services: FDA will establish a FDA Small Business Liaison program and a Young Entrepreneurs program, as well as establish a new partnership with the US Small Business Administration.
- Building infrastructure to drive and support personalized medicine: FDA will invest in regulatory science and clarify agency policies to support the emerging field of personalized medicine.
- Creating a rapid drug-development pathway for important targeted therapies: To clarify the pathway for rapid development of promising therapies, FDA will host a series of scientific meetings intended to achieve a common understanding of steps needed when an investigational drug being studied for a serious disease shows exceptional promise during the early stages of development.
- Harnessing the potential of data mining and information sharing while protecting patient privacy: FDA is rebuilding its IT and data analytic capabilities and establishing science enclaves that will allow for the analysis of large, complex datasets while preserving patient privacy.
- Training the next generation of innovators: FDA is designing a new Future Innovators Program under which promising candidates will be brought into the agency for training and experience. This program will provide FDA with important outside expertise and perspective while equipping these innovators with highly marketable skills and experience.
- Streamlining and reforming FDA regulations: The agency is reviewing its current regulations to identify burdensome, unclear, obsolete, ineffective, or inefficient regulations.
The report comes at a time when new drug applications have fallen to record lows, despite continuous increases in research and development budgets. FDA hopes that the initiatives outlined in this report will promote innovation, help developers overcome challenges in product development, and speed the delivery of safe and effective treatments to patients. In her introduction to the report, FDA Commissioner Dr. Margaret Hamburg says, “It is important to note that while these are important first steps to address the immediate concerns before us, this is an ongoing initiative at the agency and will be expanded beyond the reforms outlined in this document.”