FDA Commissioner Scott Gottlieb said that Congress should legislatively lay out the government’s role in overseeing diagnostic tests, and that the broader diagnostic testing community should work together to understand how to commercialize tests so they better benefit patients. Gottlieb’s comments came during Friends of Cancer Research’s “A Blueprint for Breakthrough” event last Wednesday (Sept. 13).

During the event, Gottlieb fielded questions from attendees regarding FDA’s current thinking on an oversight system for diagnostic tests. The agency chief said that Congress should take advantage of the opportunity to legislate on the issue.
“I think Congress needs to legislate. And I think that there are more opportunities here for Congress to think about doing something comprehensive. Because you’ve seen the stakeholders in this community start to align around some common principles in a way that they might not have been aligned certainly 10 years ago but even five years ago. So, I think that the opportunity to see some comprehensive legislation that would address some of the real concerns that different parties have are there,” Gottlieb said.

Congress recently introduced bipartisan legislation that would expand FDA’s regulation of laboratory-developed tests (LDTs). In March, Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) released a discussion draft of their bill, “The Diagnostic Accuracy and Innovation Act,” which would give FDA authority over the design, development, validation and production of in-vitro clinical tests, including LDTs.

The commissioner added that FDA will also take steps on its own, but emphasized that he does not want to prevent Congress from being able to take action. His statement falls in line with FDA’s decision, which Inside Health Policy reported on in November 2016, to not finalize its LDT guidance. The guidance would have given FDA oversight over LDTs, including notification, approval and reporting requirements for laboratories. The American Clinical Laboratory Association and some lawmakers applauded FDA’s decision, saying that guidance would have halted innovation of LDTs.

“Now that said, there’s going to be incremental steps we take on a voluntary basis to provide more regulatory touch to certain aspects of these tests. But I’m reluctant right now to do anything that would foreclose the opportunity for Congress to step in knowing that Congress has thought through this issue carefully, has done a lot of work on it already. And I think from my standpoint, from a regulatory standpoint, the optimal solution is always to have a very clear legislative framework that you’re working from rather than to try to do these things through guidance or other documents,” he said.

One event attendee also asked Gottlieb what the diagnostics community should be doing to make sure diagnostic testing is at the front of the drug pricing conversation.

“I think that the economic case for using the diagnostics in conjunction with the therapeutics is just starting to evolve in a way that it’s very, very compelling. It’s always been compelling. But I think we’re at an inflection point right now, and that’s going to involve the broader diagnostic community — and this is stepping outside my hat a little bit so I’ll be very careful — to think differently about how these things are commercialized and whether or not it’s a diagnostic being sold as a discrete entity and a drug being sold as a discrete entity, or are you selling a treatment system … And I think we need to think about that too because unfortunately our reimbursement model sometimes carves these things up in ways that isn’t always advantageous to how they are optimally delivered to patients,” Gottlieb said.

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