Today we face a different sort of crisis; the unsustainable reality that on average it takes 15 years and over one billion dollars to get a new drug to market. The scientific complexity of drug development has lead to continually increasing cost and time. If this is not resolved it will begin to reverse the positive trends in availability of new medicines for U.S. patients.
This crisis involves and affects all stakeholders and the 2012 reauthorization of PDUFA is an opportunity to begin to address several of the challenges faced by the biomedical research enterprise. As other industries have demonstrated, it is possible to innovate out of difficult situations. The goal should not be to arbitrarily lower evidentiary standards for new products, but rather to seek scientifically driven solutions for the current environment. We are fortunate that biologic information and cutting-edge science is pointing toward completely new ways to target diseases. Now, to translate these discoveries into treatments for patients, collaboration is needed across all sectors.
In the coming months Congress will evaluate the new PDUFA proposal that includes vital elements needed to help address current challenges in drug development. If passed, the proposal would significantly enhance mechanisms for input to FDA. This includes opportunities for the agency to receive counsel from both scientific experts in the field, as well as patients who are experiencing a particular condition. The agreement would also expand channels for FDA output. The biomedical research community would greatly benefit from clear guidance from the FDA on acceptable strategies for new and innovative drug development.
The PDUFA reauthorization can be a vehicle for innovation, and most importantly, continue to drive patient access to breakthrough medication. It is an opportunity to position the FDA, working with all sectors, both public and private, to better evaluate and advance new treatments that will hopefully continue to be discovered and manufactured here in the United States. This agreement is a significant step forward to bolstering one key part of the biomedical research enterprise and should be passed in an expedited manner.
Jeff Allen, PhD, is Executive Director of Friends of Cancer Research, a think tank and advocacy organization based in Washington D.C.