FDA welcomes Obama signing Cures Act

Barack Obama has in his last days of presidency signed into law the 21st Century Cures Act, which is going to help the FDA to continue with advancing medical product novelties, thus ensuring patients having treatments as quick as possible.

The act enables FDA to hire and hold expert scientist, which has been one of the challenges the FDA has been having.

The Commissioner of the U.S. Food and Drug Administration Robert M. Califf, M.D. commenting on the Cures Act signing noted how important it is the ability to recruit experts in specialized areas as the modern times bring huge advances in biology, engineering, IT and data science. He sees the future of preventive, diagnostic and therapeutic strategies to be more complex with potential to become more beneficial. He also said the complexity could bring more risk if used without adequate evidence to exclude risk from potential benefits.

He said: “This new law rightly recognizes that patients should play an essential role in the development of drugs and devices to diagnose and treat their disease, since patients are in a unique position to provide essential insights about what it is like to live with and fight their disease. That’s been our perspective as well, and it’s why FDA has continued to advance the science of patient input through our patient-focused drug development program and our partner with patients program for medical devices. As it is, Cures will enhance these ongoing efforts to better incorporate the patient’s voice into FDA’s decision-making.”

Calif added that Cures will also support FDA’s efforts to modernize and improve efficiency in clinical trial design, which has been a decades long priority for FDA.

FDA is looking forward to new approaches that will now available, and to develop an understanding of which designs should be used for which clinical issues.

“In cancer, for example, we’re already weighing the use of common control trials, which share a control arm, involve multiple different drugs for the same indication, and may even involve different companies. One of the benefits of using a common control arm is that the overall number of patients who need to be recruited and enrolled decreases, thereby optimizing clinical trial resources and potentially shortening the time it takes to get a new study off the ground,” Califf said.

Source: FDA