FDA Commissioner Scott Gottlieb offered a closer look at initiatives and investments the agency would pursue in support of novel medical technologies using new funding requested in the Trump administration’s budget for FY 2019.
Most of the proposed increase in the FDA’s budget authority is targeted for expansion of the agency’s capabilities for advancing innovative drugs and medical devices. The proposed budget would increase the FDA’s discretionary budget authority by $663 million (13 percent) from the FY 2018 continuing resolution — including an increase of $473 in budget authority and $190 million more in user fees — for a total budget of $5.8 billion.
A total of $435 million would be invested in FDA infrastructure, including costs for modernizing its facilities, and another $486 million would be allocated to efforts to approve medical devices and drugs at a faster pace, as well as to reduce time and cost of manufacturers’ market entry.
Gottlieb said the additional resources would help advance new and existing initiatives to promote innovation among manufacturers and broaden patient access through greater market competition.
The budget request also “provides the FDA with the resources to continue to fund our current programs at consistent levels” and harness the potential of continuous manufacturing platforms, Gottlieb said.
“These manufacturing platforms can bring more business back to the U.S., help lower drug and device development costs and reduce the risk of shortages,” he said.
New funding under the proposed budget would boost efforts already underway within CDRH. These include establishing a voluntary program for device manufacturers that meet objective criteria to receive certification. CDRH launched the Case for Quality Voluntary Medical Device and Product Quality pilot program late last year and began looking to enroll nine participants last month (IDDM, Jan. 9).
For those manufacturers that receive certification under the program, the FDA intends to allow the use of third-party certifiers and to offer other regulatory incentives, Gottlieb said.
“These actions would increase manufacturing innovation, accelerate availability of high-quality devices to patients and foster a competitive marketplace around device quality…that would advance device innovations, reduce manufacturing costs and improve the quality and safety of medical devices,” he said. Creating this kind of marketplace became crucial for devices not just because of their iterative nature, but because they are now more complex, he added.
CDRH also would use the new resources to create a new regulatory paradigm for digital health technologies and advance the use of real-world evidence in pre- and post-market regulatory decision-making — two efforts that are already underway.
The paradigm shift is taking place along with the launch of the digital health software Pre-Certification program, with nine participating companies ranging from diabetes startup Tidepool and wellness wearable company Fitbit to major tech companies like Apple and Samsung (IDDM, Feb. 5).
According to Gottlieb, the agency would also use the budget increase to create a Center for Excellence on Digital Health with a cybersecurity unit.
“Implementing these regulatory innovations and information technology improvements are essential for advancing software-based technologies…as the current regulatory framework is not well-suited for driving the development of safer, more effective software-based devices, including the use of machine learning and artificial intelligence,” he said.
In addition, the National Evaluation System for health Technology Coordinating Center (NESTcc) launched 11 demonstration projects this month with a $3 million FDA grant to explore the use of robust RWE in support of the FDA’s plan to increase the use of RWE. NESTcc said it chose projects, which involve participation from the FDA, Medtronic, Abbott, Me2Health, and many others for their “potential to provide proof of concept for innovative and scalable approaches to RWE generation across the medical device total product life cycle” (IDDM, Feb. 12).
Read the full budget request here: www.whitehouse.gov/wp-content/uploads/2018/02/msar-fy2019.pdf. — Ana Mulero