FDA, After Taking Heat, Offers Up Reforms to Support Pharma, Biotech & Device Innovation
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Small Business Liaison program staffed with people who have experience starting and running biomedical companies that have been able to navigate the FDA regulatory process to develop new products. These same people will help train the FDA on how to better understand and work with the small business people who are seeking various FDA approvals.
—Young entrepreneurs from university business schools will be recruited into fellowship programs at the FDA. That part of the program will help provide “first-hand access to information about regulatory review and what it takes to move a product through the FDA approval process. This knowledge base will enhance their effectiveness as future business partners, founders of companies, or investors,” the FDA said.
—The agency is working to find ways to incorporate new technologies like whole genome sequencing and biomarkers that are supposed to help pave the way for more personalized medicine, rather than prescribing drugs through trial and error to see what works for an individual—which is usually how it works today. Much of the science to support personalized medicine is “underdeveloped” and falls across multiple centers within the FDA, the agency said. To improve the scientific understanding and encourage more co-development of diagnostics to help properly select patients for personalized medicines, the FDA says it plans to increase its investment in “regulatory science”. It defines this field as “the knowledge, tools, standards, and approaches necessary to assess the safety, efficacy, quality, and performance of FDA-regulated products, will play an important part in addressing the challenges presented by personalized medicine.”
(Incidentally, UC San Francisco Chancellor Susan Desmond-Hellmann, the former president of product development at Genentech, recently told me in an interview that while some people don’t appreciate it on campus, she wants to put greater emphasis on “regulatory science” at UCSF as a way to help basic science become translated into new products for patients. The FDA said it plans to support regulatory science through collaboration with other government agencies, academic institutions, and public/private partnerships.)
—To improve coordination among the various divisions within FDA, the commissioner said she appointed a deputy commissioner for medical products to oversee drugs, biologic drugs, and devices.
—The FDA cites some willingness in the report to move more quickly on reviewing treatments with what it calls “exceptional promise.” It cited the history from the early 1990s, when AIDS activists pushed the FDA to make experimental treatments available more quickly for people who had a life-threatening illness at the time. One of the ideas FDA is working on is in regard to helping select the patients most likely to benefit in clinical trials, as a way of making the trials much more efficient than in the past.
—For medical devices, the FDA is talking about a new regulatory pathway besides the PMA path for groundbreaking new devices (which many entrepreneurs consider too time-consuming and costly) and the 510k pathway for relatively modest iterations on existing technologies. The new pathway will be the “Innovation Pathway” and will be faster than the PMA route, the FDA said. The agency will commit time and resources for better understanding of these innovative products early in the development process so “”so scientific issues and regulatory hurdles can be identified early on and unnecessary delays can be avoided.” It is also developing a “Network of Experts” to help the agency better understand the new technology.
Hamburg plans to discuss the report later today in Washington DC at the Washington Ideas Forum. I’m curious to hear your reaction to the FDA’s Innovation Initiative—what you like or dislike about it; what’s missing; and what effect you think this might have on company formation and investment in biomedical R&D. As always, you can leave a comment in the space at the bottom of this story.