Re: Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on
Unapproved New Uses – Recommended Practices
Dear Assistant Commissioner Kux:
The Alliance of Specialty Medicine (Alliance) is a coalition of medical specialty societies representing more
than 100,000 physicians and surgeons dedicated to the development of sound federal healthcare policy that
fosters patient access to the highest quality specialty care. Today, we are writing to express our concern with
the US Food and Drug Administration’s (FDA) revised “Guidance for Industry: Distributing Scientific and
Medical Publications on Unapproved New Uses – Recommended Practices.”
While the Revised Draft Guidance attempts to clarify existing guidance with respect to FDA’s recommended
practices, offering recommendations for manufacturers on best practices for disseminating scientific and
medical journal articles and scientific and medical reference texts we are concerned that it inappropriately
restricts specialty physicians’ access to scientific information provided by manufacturers on the safe and
effective use of medical products, including drugs, devices and biologics, which is an important part of
specialty medicine that improves patient care and drives innovation in clinical practice.
FDA has long recognized that physicians may use products “off-label,” even if manufacturers cannot
promote those same uses. However, disseminating truthful, non-misleading scientific information on the
medically accepted alternative uses of approved medical products, is not viewed as promotional by our
organizations. As discussed in our Position Statement on Physician-Directed Applications (see attached)
“To enhance patient care, physicians must have unrestricted access to truthful, non-misleading
information about the benefits and risks of all therapies available for treatment, including
medically accepted alternative uses of approved prescription drugs, biologics, and/or devices.
Manufacturers must be able to provide adequate directions for use of both approved and medically
accepted alternative indications of approved medicines and treatments, along with adequate
disclosures regarding risks and the limitations of scientific understanding.
Provided there is prominent disclosure that FDA does not approve such use, limitations on
communications should only be related to patient risk based on factors including the approval
status of the medicine, general medical acceptance of the treatment, and the level of scientific
sophistication of the audience.”
Toward that end, we urge the FDA to ensure that access to scientific information from manufacturers on the
safe and effective approved and unapproved use of medical products is not disrupted when the guidance is
finalized.
Thank you for considering our comments and concerns. Should you have any questions, please contact Emily
L. Graham, RHIA, CCS-P, at egraham@hhs.com.
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