Convergence: FDA unlikely to meet TAP pilot recruitment limit for FY 2024

Correction: This article and its headline were updated on 25 September to make clarifications about FDA’s TAP pilot recruitment process.

LONG BEACH, CA – The US Food and Drug Administration (FDA) is unlikely to meet its limit of 60 participants for its medical device total product lifecycle advisory program (TAP) pilot by the end of this month. Still, the agency hopes that more companies will volunteer to join once the pilot expands to include additional types of devices.

Laura Gottschalk, a TAP advisor at the Center for Devices and Radiological Health (CDRH), made these remarks at RAPS Convergence 2024 during a panel discussion on 19 September. She noted that TAP is only open to cardiovascular, neurological, and physical medicine devices until the end of the fiscal year. While there are 60 open slots, only 50 companies have volunteered for the program, and she said it’s unlikely that 10 more companies will join before the 1 October deadline.

Gottschalk told Focus that the TAP program had a slow start because companies hadn't heard of it or weren't interested in it for different reasons. Despite the slow start, she said that companies have been enrolling at a good pace.

"If we don't hit the 60, which at this point I don't think we will, the numbers are fine,” said Gottschalk. “We'll see what it brings on 1 October, after we expand the numbers into the new [Office of Health Technologies (OHT)].”

“But that's part of what I'm doing here,” she added. “We travel around and advertise for TAP just to get the word out because it is such a new project. Right now, I don't think we have any issues with enrollment."

The TAP pilot was developed under the Medical Device User Fee Amendment (MDUFA V) deal negotiated between FDA and the medtech industry to boost the development and uptake of innovative medical devices, beginning with breakthrough devices and later expanding to devices participating in the Safer Technologies Program. It is meant to allow early interactions between device makers, patient and physician organizations, and payers to flush out what data should be gathered during the product development phase to ensure it can support what patients and physicians need and what payers are willing to reimburse for.

Gottschalk noted that patient and professional societies have been really excited about the TAP pilot and getting patient access to products under development has been the unifying goal. She said that while some patient and medical societies already had mechanisms in place for interactions with companies, the pilot has been especially helpful to those groups that previously didn’t.

“We're kind of asking them for a cultural shift too, to start to think and operationalize how are you going to interact with these companies if they come to you,” said Gottschalk. “That's been kind of a challenge for some groups because they just haven't thought about this.”

One area that FDA is learning about as they move forward with the TAP pilot is how to interact with payers.

"As you can imagine sometimes payers don't want to talk to companies, especially early on, when [the companies] don't have FDA approval,” said Gottschalk. “But we are forming these relationships with them where we can talk to these private payers in a more general sense in device-agnostic ways to get their input on different endpoints they would like to see for certain types of devices, and we take that information back to our companies.”

“Another way we're dealing with that too is we're hiring external folks who actually have worked for private payer organizations and made these coverage decisions,” she added. “We're hiring them internally to the FDA, so that's a resource that you have as a TAP participant to talk to these people and get their feedback pretty much instantaneously because they're internal to us."

One of the attendees noted that start-up companies may be hesitant to participate in TAP because they may not yet have a patent for their product and discussing it with outside parties may endanger their intellectual property. Gottschalk said that before companies engage outside stakeholders, FDA encourages them to develop non-disclosure agreements (NDA).

Gottschalk also said that while she works for the FDA, her role is separate from that of the review team’s. Her job is to facilitate discussions between companies and external stakeholders, as well as agency review teams and other officials.

“I am separate from the review team as an advisor, so any sort of regulatory submission that comes in goes through the normal channels ... Review teams review those under the normal MDUFA timelines,” said Gottschalk. “What's different is the enhanced interactions ahead of time through those regular touch bases.”

"As an advisor, I work at the FDA, but I feel like I have a closer relationship with my companies,” she added. “They have my cell phone number, so I do have that constant contact with the company, and a lot of times I can take things from the company and run them by the review team."

Gottschalk noted that there is a very formal way that companies and FDA communicate, and she wants to change that culture so there are more interactions that are more natural. She said frequent meetings through the TAP pilot can facilitate that, and she's already seeing a culture shift where review teams are being more proactive and suggesting issues to talk about at meetings.

She also said she thinks the current cut-offs for those who can and cannot join the pilot may be holding back companies from volunteering for the TAP pilot. She hopes that as the pilot expands to include other offices and devices, more companies will join.

In FY 2025, the pilot will expand to ophthalmic, radiological, and orthopedic devices, and up to 125 devices can participate in the program. FDA plans to expand the program to enroll 325 devices by FY 2027 but hasn't yet settled on the additional clinical areas.

Gottschalk said the TAP pilot is currently limited to uses for a device that have been granted breakthrough designation and added that if a company spins off another device from the one in the program, that will no longer fall under the TAP pilot.

“Naturally a lot of times the questions that you're asking for that one specific device also apply to [other indications] because it's the same device, it's the same [Current Procedural Terminology (CPT)] code,” said Gottschalk. “You can get answers for multiple devices in theory through TAP, but it is limited to that indication that you received breakthrough device designation for."

Since the TAP pilot is so new, Gottschalk said that the agency hasn’t figured out when a device will be transitioned out of the pilot as it enters FDA review.

Convergence: FDA unlikely to meet TAP pilot recruitment limit for FY 2024

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