The 21st Century Cures Act, signed into law on December 13th, 2016, plans to speed drug development through an “Innovation Initiative,” according to FDA and its commissioner Scott Gottlieb. Gottlieb recently wrote on the blog FDA Voice: “FDA will soon unveil a comprehensive Innovation Initiative. It will be aimed at making sure our regulatory processes are modern and efficient, so that safe and effective new technologies can reach patients in a timely fashion.”
Gottlieb does “not want to present regulatory barriers to beneficial new medical innovations that add to the time, cost, and uncertainty of bringing these technologies forward if they don’t add to our understanding of the product’s safety and benefits.”1 This will be achieved via the new processes coming out of the 21st Century Cures Act, which provides the agency $500 million over the next 9 years.
Cures is designed to speed up the regulatory process while also taking into account patients’ views. The Act also provides new authority to assist the creation of a series of new “expedited product development programs”, one of which is the Regenerative Medicine Advanced Therapy (RMAT) designation, which is now live.
FDA plans to implement different aspects of Cures through a “detailed work plan.” For example, one plan includes the use of in silico tools in clinical trials. In silico clinical trials use computer models and simulations to develop and evaluate devices and drugs to potentially “help model study designs and come up with ones that have the highest possible chances of success, and thereby de-risk.” 1 FDA’s Center for Drug Evaluation and Research (CDER) has already begun investigating this. Gottlieb says, “We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development.”1
Additionally, the agency has established the Oncology Center of Excellence, which focuses on a specific disease area. Gottlieb believes “This new center will allow our expert review staff to work together and take a life-cycle approach to the development and post-market regulation of new cancer treatment options.”1
The FDA and Gottlieb concluded that they are entering a transformative era in science and medical technology and that “Through our implementation of Cures, and our efforts to build on its provisions through a new Innovation Initiative, we hope that our collective efforts will help consumers benefit from this new progress. FDA’s headway in pursuing the opportunities enabled by Cures illustrates the agency’s enthusiasm and commitment to the law—both its letter and its spirit.”1
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