Statement
of the
American Association of Neurological Surgeons
Congress of Neurological Surgeons
before the
Food and Drugs Administration
Public Hearing
on the Subject of
Manufacturer Communications of
Physician-Directed Uses of Approved Medical Products
November 9, 2016
My name is William Welch. I am a neurosurgeon practicing at the University of Pennsylvania Medical
Center, and I am here today on behalf of the American Association of Neurological Surgeons and the
Congress of Neurological Surgeons. I have been a member of the AANS/CNS Committee on Drugs and
Devices for over 15 years and currently serve as its vice chair. I appreciate the opportunity to participate in
today’s public hearing to address issues surrounding communications regarding physician-directed —
sometimes called off-label — use of FDA-approved medical products. We support the dissemination of
scientifically valid information between healthcare professionals and manufacturers and urge the FDA to
allow industry to provide physicians with access to such clinical information when asked.
In its notice of this hearing, the FDA posed questions about how clinicians might assess off-label
communications, possible consequences of these communications, and ways they should be regulated.
Organized neurosurgery, along with our colleagues in the Alliance of Specialty Medicine — from whom you
will hear tomorrow — believe physicians have the ability to assess and interpret clinical data appropriately.
This is an essential competency for physicians and we consider the source of all information used in shared
decision-making with our patients, assuring their appropriate informed consent regarding the risks and
benefits of treatment.
…
Read full article here
