The Food & Drug Administration (FDA) has actively engaged in efforts to issue new regulations and guidance aimed at driving innovation, reducing risk, and improving patient safety. Your company’s ability to understand, anticipate and respond to this changing environment will be a definite advantage.
Recent years have ushered in unique opportunities and challenges for companies regulated by the FDA. In addition to the new goals put in place through the User Fee Act for both pharmaceutical and medical device developers, the FDA managed to incorporate new requirements through the enactment of the 21st Century Cures Act, which, among other things, required a more streamlined drug and device approval process that would result in bringing treatments to market faster.
Shortly after the implementation of the 21st Century Cures Act, Dr. Scott Gottlieb was introduced as the new FDA Commissioner. Dr. Gottlieb returned to the FDA with the unique advantage of having served as Deputy Commissioner under Commissioner Mark McClellan, which afforded him the opportunity to “hit the ground running.”
Early on, Dr. Gottlieb indicated that the implementation of the Cures Act would be integrated into broader agency efforts. To this end, he led the development of a work plan that lays out extensive implementation targets. Within CDER, the new Oncology Center for Excellence was created, minimal risk clinical investigations were examined, a framework for regenerative medicine was created, and patient-focused drug development was addressed.
In medical devices, there was a serious focus on digital health, as well as the creation of a breakthrough devices program. Innovation has become the focal point for medical devices that continuously imagines a world that connects payers, patients and providers in a new way.
The upcoming year promises to bring even more exciting changes. The question of drug pricing and the role of generics will be a priority. With devices, the continued focus on pragmatic ways to evaluate the reasonable regulation of digital health devices is a priority. The patient will continue to be at the center of most decisions, thus allowing for greater consideration of patient-derived preference data and real-world evidence. These innovative solutions will include countermeasures and cybersecurity devices that will tackle the ever-increasing threats.
While many of these initiatives may not seem to have an immediate impact on the day-to-day work of drug and device companies, the changing regulatory landscape can actually have a profound impact on product development in many ways.