As a physician, medical policy expert, and public health advocate, Dr. Scott Gottlieb brings a great deal of knowledge and experience to his new role as Commissioner of the U.S. Food and Drug Administration (FDA). During his plenary remarks at The MedTech Conference, Dr. Gottlieb discussed some of the FDA’s recent achievements, its current priorities and potential opportunities for further regulatory innovation.
Supporting Those Impacted by Hurricanes and Patients Worldwide
Dr. Gottlieb began his plenary remarks by touching on an issue at the forefront of many of our minds: the ongoing hurricane relief and recovery efforts in Texas, Florida and Puerto Rico.
The agency’s efforts to date have ranged from helping farmers and food producers impacted by the storms to providing support to damaged manufacturing facilities. In support of Puerto Rico and the patients who rely on the medical products produced there, the FDA is working hard to get manufacturing facilities back online as quickly as possible, and to mitigate any potential shortages by helping to ensure finished goods can be exported off the island.
Innovative Approaches to Regulatory Policy
As a cancer survivor, Dr. Gottlieb has a unique appreciation for the importance of innovative regulatory policies that meet the needs of all patients. During his speech, he noted that some of FDA’s most creative regulatory policies are related to medical devices, in part due to the iterative development process for these devices and also due to more modern statutes governing the industry.
Dr. Gottlieb recognized the success of Dr. Jeff Shuren and his team at the Center for Devices and Radiological Health (CDRH) in adapting modern concepts to its regulation of medical devices. Just last month, the FDA issued final guidance on the use of Real World Evidence, and CDRH is also taking a new approach to its overall structure with the creation of its Total Product Life Cycle Office. With the creation of this new office, the agency is looking to break down review silos to enhance its understanding of the products being reviewed and to support a less burdensome approach to reviews overall.
Pre-Certification
In the course of his remarks, Dr. Gottlieb also announced the nine companies chosen for the agency’s digital health pre-certification pilot program. Apple, Fitbit, Google, Johnson & Johnson, Phosphorus, Roche, Samsung, Tidepool and Verily will be a part of the pilot, aimed at reducing the time and cost of market entry for digital health technologies that could have monumental impacts on the industry and patients worldwide.
As part of the FDA’s effort to develop an appropriate regulatory framework, the agency will also be employing an Entrepreneurs-in-Residence Program and holding public meetings to get input from the industry and the public.
Addressing the Opioid Crisis
During his Q&A with Scott Whitaker, Dr. Gottlieb also provided some insight on how the medical device industry could help to address the opioid crisis. Although he cautioned that discussions are still in the very early stages, Dr. Gottlieb discussed the possibility of creating a pain center at FDA that could examine a crosscutting approach to addressing the ongoing crisis. He also mentioned the possibility of creating of a framework for evaluating medical devices that could deliver local therapy for pain syndromes, potentially decreasing the reliance on systemic therapy and potentially addictive drugs.
For the full text of Dr. Gottlieb’s remarks, please visit the U.S. FDA website here.