60270EF7936153E78725823500832932 Hearing Summary

Senator Martinez Humenik, bill sponsor, presented Senate Bill 18-023.  Under federal law, the Food and Drug Administration (FDA) is responsible for approving pharmaceutical products that may be sold in the United States, and the FDA approval process focuses on a specific use of the drug in treating a specific condition or conditions.  This bill defines "off-label use" as the use of an FDA-approved prescription drug, biological product, or device in a manner other than the use approved by the FDA.  Under the bill, pharmaceutical manufacturers and their representatives are allowed to truthfully promote off-label uses of pharmaceutical products.  The State Board of Pharmacy is prohibited from taking disciplinary action against a manufacturer for promoting off-label uses, including revoking or failing to renew a manufacturer's license.  The bill specifies that health insurance carriers and other third-party payers are not required to provide coverage for the cost of off-label uses of a prescription drug, biological product, or device.

Diane Robinson, representing herself, testified in support of the bill.

Senator Martinez Humenik made closing comments.  She requested that the bill be postponed indefinitely.