Jeffrey Shuren emphasized recent efforts by FDA’s device center to reduce premarket clinical trial burdens in return for strong postmarket controls during the May 6 inaugural roundtable of the House Energy and Commerce Committee’s “21^st Century Cures” initiative.

Shuren also put his support behind clinical trial networks as a strategy to speed data gathering during the session on Capitol Hill, which lawmakers organized to identify strategies for accelerating the development of new medical treatments.

21st Century Cures is being spearheaded by E&C Committee Chairman Fred Upton, R-Mich., and the panel’s Oversight and Investigations Subcommittee Ranking Member Diana DeGette, D-Colo. As part of the effort, congressional, executive branch and non-governmental organization partners will hold a series of meetings highlighting what medical science thought leaders and regulators can do to clear the pathway for faster drug and device development.

“21st Century Cures” is spearheaded by E&C Committee Chairman Fred Upton and Oversight and Investigations Subcommittee Ranking Member Diana DeGette to identify strategies for accelerating the development of new medical treatments.

At the May 6 hearing, Shuren pointed to efforts out of CDRH in recent weeks, specifically two related draft guidance documents issued April 22. One guidance proposed the “Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Disease or Conditions,” or EAP, program, which would allow extensive interaction between FDA reviewers and manufacturers and the prospect of lightened premarket requirements, in exchange for postmarket controls for selected products that address unmet needs for serious diseases. (See Also see "Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway" - Medtech Insight, 22 April, 2014..)

“We would like to reduce the burden on medical innovators,” Shuren told lawmakers, and the EAP guidance lets CDRH do that by, for one, making optimal use of existing medical data, he explained. Under the program, qualifying manufacturers must submit a draft data development plan to map out expected nonclinical and clinical data collection needs. That would set off a collaborative planning process to determine a cohesive premarket/postmarket data strategy. And sometimes, certain premarket data collection can be waived, Shuren said.

While EAP has yet to be launched, the center director explained the device center is already putting part of the strategy into practice. “Recently, when a company and a health care society decided they were going to do a clinical trial, we told them, ‘don’t do it, don’t waste your time,’ we will collect registry data, and we managed it,” Shuren noted, as an example. “And if we can have those kinds of investments in this country, to allow registries to collect data every day, we think we can have a big impact on reducing burden for products to get to market.”

Shuren also highlighted the second draft guidance that provides more details on FDA’s authority to balance premarket and postmarket data collection for PMA devices, and allow manufacturers to rely more on postmarket collection of data, but to do so in a timely way that does not undermine patient safety.

UDI Rule Highlighted

Shuren also emphasized FDA’s unique device identifier rule, issued last September, as a policy that will help accelerate product development. UDIs, which will be required to be affixed to labeling and packaging for high-risk devices as of this September and for other devices after that, will strengthen the device data that can be collected from patient medical records and other sources, the FDA official said. (See Also see "FDA Issues UDI Final Rule, Removes Direct Marking Requirement For Implants" - Medtech Insight, 20 September, 2013..)

“Frankly, a lot of [data on devices] is from medical records, but it’s very hard to identify which device is used,” Shuren said. The UDI tells FDA who the manufacturer of a device is, the exact product, and which version of the device is being used on a patient.

“But here’s the next step: it’s got to get into electronic health records,” the CDRH Director added. Once every device registry contains a UDI, more complete data registries can be established. “…when those registries are there, we’re talking about easier data collection, and even in the case where the manufacturer doesn’t need to get the data, others can,” Shuren said.

Clinical Trial Networks

Another concept for accelerating the clinical trial process that attracted attention at the hearing is clinical trial networks. The networks were principally championed at the meeting by Janet Woodcock, director of FDA’ Center for Drug Evaluation and Research, but Shuren also expressed support.

A clinical trial network allows clinicians “all over the country to join [electronic health records] together and then do trials using that infrastructure,” Woodcock explained. She added that all sorts of linked networks “could very rapidly answer questions, which is really what drug development or device development is about – does this work, is this safe? – you can very rapidly answer those questions.”

Woodcock further clarified that a network is a group of trained people eager to use protocols to evaluate something, and that registries are useful for identifying patients, “and then you follow them.”

“These things are all linked together, [but] this type of infrastructure … we don’t really have,” she said.

Asked by Joe Pitts, R-Pa., who chairs the Energy and Commerce Health Subcommittee, if clinical trial networks also would work for devices, Shuren said they would.

“Actually … back in 2011 we talked about how we might better identify ‘Centers of Excellence’ so that the clinical trial sites could do a better job. These centers are very good in this area. Some of the surgeons [at the centers] might be good at heart surgery, some at bowel surgery, but that can help not only with data collection, but with [data collection] prior to market.” (See Also see "CDRH's Innovation Pathway: A Quicker Route For Breakthrough Devices?" - Medtech Insight, 14 February, 2011..)

Shuren added, If “those networks would be there for those technologies, that’s good, and they’re already in use to gather information. We’d love to see something like that.”

Shuren Highlights CDRH Actions To Ease Trial Burdens On Capitol Hill

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