Section 1 Short title
This Act may be cited as the “Opioid Addiction Risk Transparency Act”.
Opioid Addiction Risk Transparency Act
A BILL
To allow the Secretary of Health and Human Services to require that risk evaluation and mitigation strategies for certain drugs include communication plans that provide information about drug formulations or properties described in the drug labeling.
Sec. 2 REMS communication plans
in subparagraph (B), by striking “; or”;
in subparagraph (C), by striking the period and inserting “; or”; and
by adding at the end the following:
“(D) disseminating information to health care providers about the meaning of terms related to drug formulations or properties that are described in the drug labeling, including information about the limitations or patient care implications of such formulations or properties, and how such formulations or properties may be related to serious adverse drug events associated with use of the drug.”