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Congressman Morgan Griffith (R-VA) recently introduced the Medical Product Communications Act (H.R.1703).  This bill clarifies in statute several important concepts that impact how drug and medical device manufacturers can discuss truthful and non-misleading information about their products that is not included in the FDA-approved labeling.

When the Food and Drug Administration (FDA) approves a drug or device, it is authorizing the manufacturer to market the product for specific uses.  However, based on their medical expertise and informed by data generated from a variety of sources, doctors often prescribe or administer therapies at different dosages or for other “off-label” uses.  Prohibiting manufacturers from responsibly engaging in a meaningful dialogue about such uses is not the right approach. 

Congressman Griffith said, “Congress should clarify the statute so this type of scientific exchange between medical product manufacturers and health care decision-makers can occur.  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.”

“Furthermore, in my opinion, FDA prohibiting companies from communicating truthful and non-misleading information is not Constitutional, based on First Amendment commercial speech protections.”

At the Energy and Commerce Health Subcommittee hearing on March 22, 2017, Congressman Griffith discussed this issue with Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, and she committed to working with Congress going forward.

The proposed legislation would clarify the type of communications FDA could consider in determining whether a new intended use had been established by the manufacturer. Specifically, it would exempt scientific exchange from these determinations and enable manufacturers to proactively discuss information outside the scope of the FDA-approved labeling.  

The bill can be read here.