Health Law Advisor

You may be familiar with the data that FDA publicly shares on devices designated as having breakthrough status, and devices ultimately approved after receiving that status. As of September 30, 2024, 1041 devices had received breakthrough designations, and 128 of those devices had received ultimate clearance or approval. Inquiring minds want to know, though: what about the difference, the 913 devices granted breakthrough designation but at least not yet approved or cleared? 

I wanted to learn as much as I could about those devices, so I submitted a FOIA request.  The numbers are not going to match up with the public data, in part because my FOIA request only extended through June 1, 2024.  But the data FDA shared in response to my FOIA are quite revealing, both about where industry has placed its development priorities in terms of potential breakthrough devices and where FDA seems inclined to grant breakthrough designation. We also learned how quickly FDA responds to requests for breakthrough designation.

Results

Let’s start with how quickly FDA responds. As a preliminary note, these data only reflect where the designation has been granted, not whether designation has been rejected. I have no data on rejections. But at least for those where FDA responds favorably, here’s what the responses look like in terms of timing by therapeutic area.

On September 15, 2021, CMS published a proposed rule that would repeal a final rule that created an expedited pathway for Medicare coverage of breakthrough devices and established formal criteria for applying the “reasonable and necessary” standard for coverage in Section 1862(a)(1)(A) of the Social Security Act, which has been the basic standard for coverage since the inception of the Medicare program.[1]  CMS has set a short period for comments, and interested parties must submit comments by October 15, 2021.

The new proposed rule reflects a significant policy change.  Where the initial rule focused on expanding access to new innovations, the current approach focuses more on Medicare program goals and outcomes data.