The medtech firms criticized a new priority review pathway proposal in Australia, saying it would not actually cut the time it takes for patients there to access new medical devices.

Amanda Pedersen

Medtronic and Johnson & Johnson are leading the industry in a pushback against a new regulatory proposal of medical devices in Australia.

The Therapeutic Goods Administration (TGA) published a consultation paper last November that detailed the agency's proposal for a priority review pathway, which it said is intended to accelerate the country's regulatory assessment of new medical devices.

Medtronic and J&J provided feedback to the TGA on the proposal. The agency said it received a total of 13 responses to the paper, including six from industry and regulatory consultants, two from industry representative groups, three from health professional groups, and two from consumer groups.

Both Medtronic and J&J appear to support the intended purpose of the priority review pathway, but the companies raised a number of concerns regarding the ability of the proposal to deliver on its intended benefit.

"We have concerns that the current proposal does not actually allow for accelerated assessment, but rather 'front of queue' processing with a designation process that may limit the overall reduction in review times," J&J said in its submission.

The company said it is also concerned that only technology having substantial clinical data would be considered for priority review. "This would seem to exclude promising new technologies that may have limited clinical data at the earliest stages of development, but would benefit from expedited review," J&J noted, providing FDA's expedited access pathway (EAP) as an example.

The EAP allows manufacturers whose device meets the specified eligibility criteria for EAP designation to work with FDA to reduce the time and cost from development to marketing decision without changing the standard of reasonable assurance of safety and effectiveness, J&J said. The U.S. program relies on priority review, submission of a data development plan, interactive review, senior management involvement, and an assigned case manager who oversees the process, the company noted.

Both J&J and Medtronic raised concern about the TGA's ability to assign additional review resources to the proposed pathway without adversely impacting applications that are being evaluated under standard mechanisms. As an example of why this would be a concern in Australia, J&J cited the TGA's recent delay in Level 2 application audits due to clinical assessor resource constraints. There may be further limitations as to the availability of appropriately qualified subject matter experts to evaluate such novel technologies, according to the company.

J&J also asked the agency to clarify certain terms such as "life-threatening," "seriously debilitating," and "major clinical advantage." The company said it is concerned about the eligibility criteria outlined in the proposal, as it appears to rely heavily on pre-market clinical evidence to demonstrate a "major clinical advantage."

Because pre-market clinical data may be limited for novel devices, J&J recommended an evaluation of the benefit-risk profile for the device to support the argument for greater reliance on post-market data where patients will benefit from expedited access to the technology.

"Devices could be granted provisional approval where the benefit to a specified patient population of earlier

availability outweighs the risk inherent in the fact that additional clinical data is still required," J&J said.

Based on the current proposal, both companies said it is unlikely that they would participate in the priority review pathway.

"The criteria will not be useful for many of the overseas manufacturers, as they will be using their own regulators to access the priority pathway," Medtronic said in its submission.

The TGA's expectation of 'clinical evidence' will mean devices will have to wait until the evidence is satisfactory according to the current TGA draft guidance on clinical expectations, Medtronic noted. The company suggested the agency should accept the device for review if the comparable overseas regulator, such as FDA, has already accepted the device under its program.

"In our experience, the comparable overseas regulators have discussions in advance in terms of expectation of 'clinical evidence,' and then the application is assessed based on the agreed evidence," Medtronic said. "There is no such avenue available with the TGA."

Offering a different viewpoint, from a provider perspective, the Australian Medical Association (AMA) supported the priority review pathway proposed by the TGA. The organization acknowledged an understanding that the new program would require medical devices to meet the same clinical evidence requirements currently required for all devices submitted for approval in the country, and that the expedited assessment would be achieved through changes to administrative processes only.

The TGA said it would make some changes to the draft in response to some of the comments it received. The agency said it expects to implement the new pathway at the beginning of next year. Additional commentary on the proposal, including the agency's planned changes based on some of those comments, can be found here.