Subject: Review of Existing Center for Devices and Radiological Health Regulatory and
Information Collection Requirements
Dear Dr. Gottlieb,
The American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons
(CNS) appreciate the opportunity to provide our recommendations to assist the agency in its effort to
identify existing regulations and related paperwork requirements that could be modified, repealed, or
replaced, consistent with the law, to achieve meaningful burden reduction while allowing it to satisfy its
public health mission and fulfill statutory obligations. Neurosurgery has a long history of collaboration
with the Food and Drug Administration (FDA), as our specialty, highly dependent on medical technology,
is one of rapid innovation. We are, therefore, eager to share our views on ways to enhance efficiency in
bringing lifesaving improvements to our patients.
Physician Directed Use of Medical Products
The AANS and CNS have been active for many years on the issue of preserving physician-directed —
referred to as “off-label” — use of FDA approved products. On Nov. 9, 2016, organized neurosurgery
presented its views at an FDA public hearing on off-label promotion issues, held as part of a
comprehensive review of FDA regulations and policies governing firms’ communications about
unapproved uses of approved/cleared medical products. In March 2017, the AANS and CNS joined the
Alliance of Specialty Medicine in updating its Statement on Physician Directed Use. Included in the
updated document is the recommendation that the FDA add language to drug and device labels to
highlight the fact that, after marketing approval, additional scientifically valid data may become available
to justify new uses, dosages, or contraindications and physicians should consider this information when
prescribing the product. The goal of adding the language is to destigmatize the concept of off-label use
and foster appropriate communication with patients. The updated Alliance statement was included in the
FDA’s docket of materials on the issue. These documents are in the public record at the FDA and are
attached.
…
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