FDA Aims To Spur Biomedical Innovation

FDA has identified several steps it can take immediately to help reinvigorate the U.S. biotech and pharmaceutical industries and spur innovation. In its report titled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,” released last week, FDA lays out a plan to rebuild outreach services with small businesses and work with the Small Business Administration to educate entrepreneurs about regulatory science. Other initiatives in the plan include building the infrastructure to support personalized medicine, creating a rapid drug development pathway and new clinical trial models, improving the consistency of the medical device review process, and streamlining and reforming FDA regulations. Last year, FDA received the lowest number of applications for new drug approvals in several decades, FDA Commissioner Margaret Hamburg noted at an Oct. 5 briefing. “The number of new products in the drug development pipeline is not where we would want it to be and is not commensurate with the medical and public health needs,” Hamburg stressed. FDA wants to be a “gateway, not a barrier” to biomedical innovation, she said.