The FDA and its new Trump-picked commissioner Scott Gottlieb took to social media to talk up the agency’s plans to speed up the drug regulation process.
He writes on the blog FDA Voice that: “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.
“We need to make sure that our regulatory principles are efficient and informed by the most up to date science. We don’t 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.”
This will be undertaken, predominately, via the new processes coming out of the 21st Century Cures Act, signed into law last year, which gave the agency $500 million over the next 9 years.
In the words of the FDA, Cures is designed to speed up the regulatory process while also taking on board the views of patients when it comes to drug development. It also wants to modernize clinical trial designs as well as clinical outcome assessments, which it hopes will help speed up the development and review of new meds.
Additionally, the Act provides new authority to help the FDA to create a series of new “expedited product development programs,” including the Regenerative Medicine Advanced Therapy (RMAT) that offers a new accelerated option for certain biologics, and new institutes to help coordinate activities in major disease areas between the drug, biologics and device centers and improves the regulation of combo products.
Gottlieb has now set out a “detailed work plan” for the steps the FDA is taking to implement different aspects of Cures. One of these plans is the use of in silico tools in clinical trials for “improving drug development and making regulation more efficient.”
In silico clinical trials use computer models and simulations to develop and evaluate devices and drugs. In a nutshell, the idea is that this can help model study designs and come up with ones that have the highest possible chances of success, and thereby de-risk.
The FDA’s Center for Drug Evaluation and Research (CDER) is already working on this, Gottlieb says, adding: “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.”
The agency has also established the Oncology Center of Excellence, the first “inter-center institute” at the FDA that focuses on a specific disease area rather than a type of product. “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.”
Gottlieb concluded: “We’re at the beginning of a transformative era in science and medical technology. 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.”
But not everyone sees this as a positive. Adam Feuerstein, formerly of The Street and now senior biotech writer at STAT, said in reply to Gottlieb on Twitter about the new plans: “I read this for you, allow me to translate: The FDA intends to approve all drugs. Fast. You’ll really have to f**k up to get rejected.”