Advocacy groups, AdvaMed vie for next phase of TAP pilot

Medical devices that treat brain diseases and disorders should be the next products to be accepted into a US Food and Drug Administration (FDA) pilot program that aims to shorten the time it takes novel devices to reach patients, a nonprofit advocacy group told the agency. The industry lobby group AdvaMed meanwhile called on the agency to select an office with limited experience with the Breakthrough Devices Program.
 
In comments submitted to the agency, the American Brain Coalition (ABC) asked FDA to expand its voluntary Total Product Life Cycle (TPLC) Advisory Program Pilot, or TAP, to include devices that treat an array of brain conditions. The agency says TAP will streamline the device clearance process and will allow for earlier and more frequent engagement between developers and FDA’s Center for Devices and Radiological Health (CDRH), among other benefits.
 
“The neuroscience community has made groundbreaking advances in understanding brain and CNS [central nervous system] mechanisms in health and disease, expanding the number of promising and feasible targets for impactful treatments and cures,” ABC chair Matthew Rizzo wrote. “FDA can amplify the power of these discoveries through administrative innovations and commitments that ensure patients get timely access to potentially lifesaving treatments, and that these treatments are affordable and broadly available.”
 
A mere 15 manufacturers were invited to take part in TAP’s inaugural phase, which began on Jan. 1 and runs through Sept. 30, the last day of the current 2023 fiscal year. Companies playing in the first phase of the pilot must sponsor a device that falls under the purview of CDRH’s Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices. FDA says it will expand TAP in FY 2024 by adding a second OHT and 45 other types of products.
 
“ABC requests that OHT5, the Office of Neurological and Physical Medicine Devices, be the next OHT included in the TAP Pilot,” Rizzo wrote, noting that his group has “long called for more transparent and streamlined review processes, with public feedback on emerging needs and outcomes, to advance evidence-based treatments for brain conditions.”
 
In an unsigned letter to FDA, the Epilepsy Foundation said it “wanted to ensure that the importance of epilepsy-related devices is understood as the TAP pilot is launched.”
 
TAP was at the top of FDA’s wish list during its negotiations with the device industry last year for the latest iteration of the Medical Device User Fee Amendments agreement, MDUFA V. The pilot was built on lessons the agency learned from its interactions with sponsors for pre-Emergency Use Authorizations during the COVID-19 pandemic, as well as FDA’s Early Feasibility Study Program and Breakthrough Devices Program.
 
In comments made late last year, FDA device center director Jeff Shuren said TAP would focus first on “CDRH-designated Breakthrough Devices.” The Breakthrough Devices Program is an accelerated development pathway for products that the agency finds could provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, addressing an unmet need.
 
While AdvaMed didn’t name a specific OHT that should be part of TAP, the industry advocacy group nevertheless said in its comments to FDA that the “next OHT should be one with the least Breakthrough Devices Program experience.”
 
“The TAP pilot must be effective across all OHTs, regardless of Breakthrough Devices Program experience, and thus, we believe that including an OHT without significant Breakthrough Devices Program experience would provide a broader perspective on the effectiveness of and potential areas of improvement for the program,” wrote Anita Nosratieh, AdvaMed’s associate VP for technology and regulatory affairs.
 
FDA plans to further expand TAP in FY 2025 by including even more OHTs and up to 65 other types of devices. And in FY 2026 the pilot will be opened up to products enrolled in CDRH’s Safer Technologies Program – STeP – which is modeled on, and is a complement to, the Breakthrough Devices Program.
 
FDA had asked for stakeholder comments on TAP in an October 2022 Federal Register notice, but received only four by the 10 January deadline. No device makers commented.
 
In a 13 January interview with Focus, former FDA official Steve Silverman said he wasn’t surprised by the lack of input from manufacturers.
 
“I suspect there are a limited number of comments for at least two reasons,” said Silverman, who is head of The Silverman Group consulting firm, and a former director of CDRH’s compliance office.
 
“First, the TAP program is just beginning and FDA is looking only for a small number of participants, specifically in the cardiovascular space, and within the confines of the Breakthrough Devices Program,” he said. “Given those constraints, it’s not surprising to me that the number of parties with interest sufficient to support comments is limited.”
 
Second, “TAP was discussed extensively between FDA and medical device companies during the user agreement negotiations, and those discussions provided an opportunity for companies to share their perspectives,” Silverman added. “As a result, there is less reason for those companies to communicate their views once again.”
 
Silverman said that while he isn’t sure how many device makers will ultimately be interested in joining TAP, it was nevertheless obvious that the FDA has thrown its weight behind the pilot program.
 
“I don’t know whether the program will be very appealing to device companies. I don’t know how much uptake there will be. What I do know is that by design, the program is structured to begin relatively small and to increase incrementally, so it has an ability to gain momentum over time,” he said. “And all evidence from the device center is that there is very strong commitment to it and support, and it’s being treated as a priority.”