SUBJECT: Comments on Request for Feedback on Cures 2.0 Legislation
Dear Reps. DeGette and Upton:
On behalf of the American Association of Neurological Surgeons (AANS) and the Congress of
Neurological Surgeons (CNS), we appreciate the opportunity to provide our comments on legislation to
follow up on the 21st Century Cures Act, P.L. 114-255. We commend you for your efforts to build upon
the excellent foundation established in the 21st Century Cures Act and look forward to working with you
as you craft important provisions of Cures 2.0.
Support for the Use of Registry Data
Although the 21st Century Cures Act did include a mandate for a breakthrough medical device process to
help bring important innovation to patients, the final law did not include specific language to clarify that
valid scientific evidence may include registry data. The neurosurgery-led NeuroPoint Alliance (NPA) has
worked closely with the FDA and other societies on several important initiatives to explore “real world”
data sources and alternatives to costly and time-consuming randomized controlled trials. As you move
forward with Cures 2.0 and consider more timely and innovative ways to assess clinical efficacy and
safety, we urge you to continue to formulate language to strengthen the use of registry data to help bring
potentially life-saving medical products to patients more quickly and affordably. In addition to the use of
registry data to speed innovation and device approval, registry expertise is useful for post-market
surveillance.
We are eager to share our registry experience, including the multispecialty projects such as the
American Spine Registry (a collaborative project with the American Academy of Orthopaedic Surgeons)
and an initiative with the Society of NeuroInterventional Surgery to establish a single registry for
neurovascular surgical procedures. In the case of the neurovascular registry, we are working with the
FDA to use the data to evaluate thrombectomy devices for the treatment of stroke.
The AANS and the CNS remain convinced that these registries are precisely the kind of collaborative
efforts that will lead to better care, and ultimately outcomes, for our patients. We, therefore, applaud
your dedication to foster a regulatory environment that supports and encourages the use of real-world
data and encourage Cures 2.0 to include more explicit language to support registry data for device
approval and post-market surveillance.
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