Several senators pressed FDA commissioner nominee Robert Califf about what could be done to improve postmarket device surveillance during his Nov. 17 confirmation hearing in the Senate Health, Education, Labor and Pensions Committee. And Califf, currently a deputy commissioner at FDA, emphasized the need for funding from Congress to expand the Sentinel surveillance system to track device safety.

HELP Committee ranking member Patty Murray, D-Wash., raised the issue during the hearing particularly in relation to contamination incidents with duodenoscopes used in endoscopic retrograde cholangiopancreatographys (ERCP) procedures in Washington state and other states. (See Also see "Bacterial Outbreaks Triggering Tougher FDA Reprocessing Standards" - Medtech Insight, 6 March, 2015..)

“So-called ‘superbugs’ are [a] growing threat, and an issue Chairman [Lamar] Alexander and I are working on closely. As we’ve seen in my state and across the country, where medical devices known as duodenoscopes have been linked to tragic outbreaks of antibiotic resistant infections, we need to find ways to prevent these infections – and respond more quickly and effectively when any risk arises,” Murray said in her opening statement.

“What steps would you take to improve the postmarket surveillance system for devices for patients?” she asked Califf.

The nominee acknowledged that as a practicing cardiologist he was familiar with the importance of ERCP procedures in saving lives of the critically ill. FDA investigated the contamination incidences, Califf said, and worked with the duodenoscope companies to reduce the risks. (See Also see "Duodenoscope-Makers Ordered By FDA To Conduct Sec. 522 Postmarket Surveillance Studies" - Medtech Insight, 5 October, 2015..)

Contaminated duodenoscopes could have been noticed, and remediated faster, if a Sentinel system for devices had been in place, FDA commissioner nominee Robert Califf says.

But, he added, “I think we really need to work on our postmarket surveillance of devices, and I really hope you’ll help us with this.”

Califf stressed that the Sentinel surveillance system, which has been successfully used to track drug problems that effect patients, should be applied to devices, as well.

“We need the same system on the device side. Imagine these contaminated duodenoscopes – if there had been such a system we would have seen the problem,” Califf commented.

“Industry could contribute to that, but we could see it done independently of industry and act on it much more rapidly,” he added, noting that he wanted to work with Congress to expand Sentinel but needed much more funding for the system to make it a reality. "We have plans to do that but we’re going to have to work together with you to figure out how to fund it and how to fold it in with that Sentinel system," he said.

Sen. Al Franken, D-Minn., also asked Califf what additional authorities FDA needs to improve postmarket device surveillance. Califf did not provide a detailed response, noting, “When we find a problem … we can deal with it, but we’ve got to have good data and quickly, in order to identify the problem.”

Calls For A National Evaluation System

Califf told Sen.Tammy Baldwin, D-Wisc., in an exchange about the greater need for transparency for the results of both drug and device trials, about how the Sentinel system not only needed to be expanded more to the device side, but also needs “innovative approaches” to take the data gathered, and to make it public.

He added that he had spoken to both FDA’s device center chief Jeff Shuren and drug center chief Janet Woodcock about a medical product “national evaluation system” for medical products.

Baldwin noted that “companies do not consistently report clinical trial outcomes,” and asked the commissioner-nominee how he would improve public access to clinical trial outcomes for all medical products.

Califf urged “the publication of all details of trials in medical journals,” and also pushed for greater use of ClinicalTrials.gov, a Web-based resource maintained by the National Institutes of Health that provides patients, providers and researchers with access to information on publicly and privately supported clinical studies on medical product trials.

Lab-Developed Tests

Postmarket surveillance was one of several device-specific topics raised during the confirmation hearing, during which most senators expressed support for Califf's nomination, with some exceptions. Combination product reforms were highlighted. (See Also see "Califf Supports Combo Products Pathway At Confirmation Hearing" - Medtech Insight, 17 November, 2015..)

In addition, Califf fielded several questions on FDA’s proposed laboratory-developed test (LDT) guidance. The confirmation hearing was proceeding at about same time as a hearing on the regulation of diagnostics in the House, where FDA and CMS officials were defending the agency's plan to regulate LDTs in response to congressional proposals to revamp FDA's authorities. (See Also see "CMS And FDA Stand Together Behind FDA Oversight Of LDTs At House Hearing" - Medtech Insight, 18 November, 2015..)

The commissioner nominee told Sen. Richard Burr, R-N.C., for example, that as a practicing clinician he has been “well aware” of the performance of lab-developed tests, and efforts to make those tests better.

Califf remarked: “This has become a big industry, as an application for precision medicine where you have a test, and it tells you what therapy to give. These tests can be really good, or really bad."

Further, “We are committed to work with the whole ecosystem, so there is a standard for tests, so that they have analytical validity, and clinical validity,” he said.

Every time FDA works with Congress and industry on user fees, both ask for more guidances, “so there is a great demand for these,” Califf says.

Sen. Johnny Isaakson, R-Ga., complained during the hearing specifically about FDA’s decision to use guidance rather than rulemaking to advance its framework for LDTs lab developed test framework.

“One thing that is really obvious to me in my short time at FDA [is] that everybody wants to know what FDA is thinking. So I think there is tremendous value in guidance documents, just to let everyone know what FDA is thinking. And there are other situations that call for rulemaking. I understand there is a difference, and I’ll be willing to work with you as things come up,” Califf told Isaakson.

Isaakson persisted, wanting to know if FDA would insist that its guidance documents – including for LDTs – could be considered binding rulemaking.

“Senator, I believe the guidance documents clearly say that they are not binding,” Califf answered.

Sen. Pat Roberts, R-Kan., pressed Califf on the length of time guidance documents remain in draft form. (See Also see "CDRH Sets Performance Goals To Reduce Draft Guidance Ambiguity" - Medtech Insight, 8 January, 2015..) “Every time we … work together on a user fee situation, [Congress and industry] always mention guidances they want," Califf responded. "The demand exceeds what we have, what we can do on those. So I’d be willing to come and talk to you about what the processes are for those so people can understand.”

Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing

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