Representative Morgan Griffith (R/VA) has introduced HR 1703, the Medical Product Communications Act. It’s legislation that would take a lot of the ambiguity out of the FDA’s biggest conundrum – regulatory clarity on the sharing of truthful accurate, and non-misleading off-label information.
As Mr. Griffith writes in a Dear Colleague letter, “Doctors should have the most up-to-date information when caring for their patients and, when done responsibly and in an appropriate context, manufacturers should be able to provide it.”
Amen.
For more detail on the issue, have a look at this new article from the Therapeutic Innovation and Regulatory Science (the official journal of the Drug Information Association), “Using Off-Label Communications to Responsibly Advance the Public Health.”
As Mr. Griffith writes in a Dear Colleague letter, “Doctors should have the most up-to-date information when caring for their patients and, when done responsibly and in an appropriate context, manufacturers should be able to provide it.”
Amen.
For more detail on the issue, have a look at this new article from the Therapeutic Innovation and Regulatory Science (the official journal of the Drug Information Association), “Using Off-Label Communications to Responsibly Advance the Public Health.”
