"The United States currently is using a regulatory framework for drugs and devices that was developed during the 20th century when iron lungs were still in use, the polio vaccine was just being discovered, genomics were just a science fiction dream, and personalized medicine meant your doctor made house calls," Sigal said. "While the long-standing requirements for assessing the safety and efficacy of new products remains the cornerstone for protecting and promoting public health, the stepwise addition of regulatory responsibilities has created an agency that is oriented to the type of products it regulates rather than the diseases they're intended to treat."
Sigal noted that FDA's organizational structure had not been revamped since the 1970s.
"The existing regulatory framework has been defined by a divide and conquer approach to oversight; separate centers within FDA regulate three major categories of medical products: drugs, devices and biologics," she said. "This organization was appropriate for the science of that era; drug and device regulation involved little overlap and the separate FDA centers were able to regulate their respective products without needing to coordinate efforts."
Sigal also maintains that technology and science advancements have not been addressed.
"Advances in science and technology have led to treatment protocols that involve different types of medical products over the course of treating patients," she said. "In addition, many of these products are now being developed concurrently, such as drugs that require a diagnostic test to identify patients who are most likely to benefit. Having these products regulated within isolated portions of the FDA can lead to incongruent timelines that may result in development delays."