An insightful article by Robert Goldberg of the Centers for Medicine in the Public Interest, entitled “The future of drug development,” appeared today on the FiercePharma web site.
One can only commend Dr. Goldberg for his “glass half full” view of the current situation at the FDA. The moaning about the FDA’s supposed failure to approve “enough” NMEs in 2007 and probably in 2008 is an inaccurate reflection on the current situation, which has more to do with failures of innovation and failures of development practices than it has to do with an overworked and underappreciated Food & Drug Administration.
The future of drug development is dependent on the idea of entrepreneurial research and development, not on the historic R&D models used in some companies well beyond the 1970s and 80s. Too many companies are overburdened by non-innovative processes. Scientists have become internal pharmaceutical company beaurocrats, and corporate leadership is all too often divorced from the innovation needed in their own laboratories and clinical development groups.
Health + Vision joins with Dr. Goldberg to encourage a renewed commitment to entrepreneurial innovation, a process of cooperation with and support for the FDA (whenever possible), and a clear message that undue regulation will only drive up the prices of innovative pharmaceuticals even further than may already be necessary.
Through our own unwillingness to adapt in a changing environment and clamp down on our worst excesses, we have let our industry become stifled by lawyers and intellectual grammarians. This is no way to develop molecules for the meaningful implementation of personalized medicine. What that requires is inventive thinking and a determination to “do the right thing” more often that has been evident in recent years.
Filed under: Business strategy, Drug approvals and regulation, Drug development / clinical trials | Tagged: FDA, future, innovation, NME
