Pathways’ Pick of the Week: FDA Commish Confirmation Hearing – What to Watch For

[For a complete roundup of medtech policy happenings that should be on your radar this week and deeper analysis of the sector, check out Market Pathways.]

While the highest profile congressional hearings are happening this week in the US House (see: impeachment inquiry), device makers may want to direct their attention on Wednesday to the Senate, where the Health, Education, Labor and Pensions Committee will be running the confirmation hearing for Stephen Hahn, MD, the Trump administration’s nominee to be the next commissioner of the FDA.

Hahn, a radiation oncologist and the chief medical executive for the MD Anderson Cancer Center at the University of Texas, is not expected to provide detailed responses on his policy plans at the agency. And Hahn, who is not coming with a history of government service (other this his experience as a National Cancer Institute oncologist in his fellowship days), is likely to emphasize his effectiveness as a healthcare leader and his experience with innovative medical technology. But confirmation hearings are, nonetheless, a good forum to listen out for key tidbits of focus that might important to an upcoming commissioner’s tenure. And, even more so, the questions posed by senators offer a view into the priorities of key lawmakers in setting future FDA policy directions.

No doubt several non-device issues will have top billing at the hearing, in particular FDA’s oversight of vaping and its role in the drug pricing debate. But the multi-hour hearing will hit on many topics, and there’s no question that several members of the HELP Committee are paying attention to medical device oversight. Three medtech topics that could be question fodder during the hearing have recently been the subject of recent oversight letters sent by members of the HELP Committee to FDA leadership:

• Digital health: Sen. Patty Murray (D-WA), the top Democrat on the HELP Committee, has recently joined Sen. Elizabeth Warren (D-MA) in pressing FDA on multiple different device regulatory issues, including the agency’s plans to oversee digital health products. Murray, Warren, and Tina Smith (D-MN) sent a letter to the agency October 30 questioning whether its nascent “pre-certification” program could ensure patient safety with use of new health software devices, making it relatively likely that at least one of the senators will question on Hahn on the topic. (Although, it is not likely presidential candidate Warren will make the hearing, which falls on the same day as a Democratic presidential debate in Atlanta.)
• Progressive Approval: The other area where Murray and Warren have recently expressed big concerns is FDA’s consideration of “progressive approval” as a framework for approving certain devices with less evidence of effectiveness, conditioned on collecting the needed data in a set period of time. A November 4 letter on the topic from the senators could serve a platform for questions at the hearing.
• Device servicing. Warren also sent yet another letter to the agency on a device issue in October, this time with Louisiana Republican Bill Cassidy, also on HELP. It questioned FDA on how it planned to address the differences between firms that “service” devices, which are not subject to FDA oversight, and those that “remanufacturer” devices, which are subject to oversight. 

Three other medtech topics that could get a spotlight in questioning:

• Device shortages: Warnings of possible dire device shortages have picked up in recent weeks from both FDA and the device industry in the face of state actions to close facilities that sterilize devices using ethylene oxide (EtO) gas due to concerns of cancer risk. FDA is looking for short- and long-term contingency plans in the face of forced reduction in EtO sterilization capacity, while remaining in contact with national and state environmental regulators. The agency also wants new authorities from Congress to compel device companies to keep the agency abreast of shortage risks. The issue has received significant enough national attention that its likely at least one lawmaker will bring it up.
• Sterilization: On the flip side, there is likely to be a question FDA’s assurance of proper sterilization of certain devices, in particular reusable duodenoscopes, which were linked to a bacterial infection outbreak several years ago. Sen. Murray has closely scrutinized FDA’s handling of that issue, and she was the force behind several reforms in recent years to help address it. She is likely to bring the matter up at the hearing, which comes a few days after FDA approved the first duodenscope that includes a key disposable component to reduce the parts that need to be disinfected. 
• Diagnostics: Finally, FDA’s oversight of diagnostics could get some attention at the hearing. Lawmakers are in discussions with the agency and industry about the prospective of legislation to establish a new FDA regulatory framework that would encompass lab test kits (IVDs) that are currently routinely regulated by FDA and laboratory-developed test services (LDTs), which generally are not subject to FDA oversight.

While it is likely Hahn will go up against some tough questions from Democrats on the committee, there is no sign so far that he will run up against a major barrier to confirmation in the Republican-controlled Senate. The main question will be timing of the necessary votes on the nomination that must be scheduled—first for the HELP Committee and then for the full Senate—before Hahn can start the job.

Regardless, it is not anticipated that confirmation of Hahn or any new FDA commissioner will have a major impact on FDA device policies, where veteran CDRH Director Jeff Shuren, MD,  will continue to lead the way.

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