RE: Support for the “Medical Product Communications Act of 2017” (H.R. 1703)
Dear Congressman Griffith:
The Alliance of Specialty Medicine (the “Alliance”) represents more than 100,000 specialty physicians. The
Alliance is deeply committed to improving access to specialty medical care through the advancement of sound
health policy.
The undersigned members of the Alliance are writing to thank you for your introduction of H.R. 1703, the
Medical Product Communications Act of 2017. The current regulatory paradigm to determine a product’s
“intended use” by the Food and Drug Administration (FDA) has created uncertainty amongmanufacturers, which
in turn hampers the free exchange of information.
For some specialties, a so-called “off-label” use – or use of a medicine or device for an indication not approved
by FDA – is the standard of care. As such, the free flow of data on such off-label uses is critical to advancement
of the practice of medicine. Unfortunately, the current way FDA determines the “intended use” has a negative
impact on such scientific exchange.
Your legislation would establish clear parameters on what constitutes a “scientific exchange” by which a
manufacturer could, within defined limitations, share data related to an unapproved indication. We believe that
H.R. 1703 strikes the right balance between placing reasonable and sound limits on manufacturers and allowing
a productive, scientific exchange of data that will benefit patients.
In closing, we thank you for your commitment to this important issue and stand ready to help you advance the
Medical Product Communications Act of 2017. Please do not hesitate to contact us should you have any
questions or require additional information.
Read full letter here
