Bradley Merrill Thompson Quoted in “Device Lawyer: FDA’s Pre-Cert Update Seems Promotional, Lacks Answers”

Inside Health Policy

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Device Lawyer: FDA’s Pre-Cert Update Seems Promotional, Lacks Answers,” by Beth Wang. (Read the full version – subscription required.)

Following is an excerpt:

Brad Thompson, a member of the firm Epstein, Becker & Green, tells Inside Health Policy he had to do a doubletake on the update from FDA, as he says it sounded like promotional materials.It also lacked significant detail, which FDA’s own scientists would find unsatisfactory, he said.

He argues that while the information makes it seem FDA is conducting scientific studies of administrative processes, the agency is actually just testing administrative procedures to make sure they’re feasible.

For example, in conducting its retrospective testing, FDA took the same information that has historically been submitted to the agency and repackaged it for review.

“That suggest[s] that there’s really fundamentally nothing different about precert: it’s looking at the same information only packaged differently and reviewed over three different reviews – the Excellence Appraisal, the Review Pathway Determination and the Streamlined Review – with the added feature that real-world performance will also be evaluated in the future,” Thompson says.

Thompson also lays out questions he believes FDA left unanswered – questions he says seem to be important to everyone except FDA.

For one, FDA asks whether the pre-cert process can produce the same level of assurance of safety and effectiveness that traditional pathways provide, but Thompson believes FDA is just looking to confirm its own bias that it will work.

He argues that FDA reveals its bias in the first paragraph of the document where it says the goal of the test is “to confirm that the framework … provides an equivalent reasonable assurance of safety and effectiveness for software products as our traditional review pathway.”

But Thompson isn’t sure how FDA will prove the pre-cert program is just as reliable.

“It may be that they’re planning to use a surrogate endpoint whether the same administrative decision is reached,” he says. “But there certainly is no suggestion that the number of reviews they are doing will be statistically significant, or that they are taking other measures to assure the integrity of the data such as random sampling and blinding. It all seems very anecdotal and, in a statistical sense, biased.”

Thompson also wonders whether the pre-cert program will be faster from start to finish, based on review time, and less burdensome than traditional regulatory pathways.