Dear Acting Commissioner Ostroff,
We are writing to express support for addressing barriers to communication that exist between
physicians and drug and device manufacturers. To enhance patient care, physicians must have
unrestricted access to information about benefits and risks of all therapies for treatment, including
medically accepted alternative uses of approved drugs, biologics, and/or medical devices.
Physician-directed applications, “off-label” uses, or medically accepted alternative uses are an important
component of the evolving practice of medicine. It is not uncommon for “off-label” uses to become
standard of care. In fact, for certain subgroups (such as children and minorities) and conditions (such as
certain types of cancer and rare diseases), an “off-label” therapy may be the accepted standard of care.
In addition, important data about drugs and devices may be consistent with the FDA-approved use, but
nevertheless exist outside of FDA-approved labeling. We are concerned that the companies that
research, develop, and bring these treatments to market may not proactively communicate about useful
information that they hold that is outside of the FDA-approved labeling. This may include important
data related to subpopulations such as minorities, women, and any other groups who are traditionally
underrepresented in clinical trials.
It is the mission of physicians in all specialties to use the safest and most effective means to assist
patients in health maintenance, disease prevention, effective disease management and accessing
curative therapies. Most of these endeavors are accomplished with the use of treatment modalities that
are not only the standard of care but also FDA approved. However, in instances and circumstances
where no definitive FDA-approved indication is available, the use of medically accepted alternative uses
of approved medicines is often necessary.
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