Bill Caption

Relating to the promotion of off-label uses of certain drugs, biological products, and devices. 

Fiscal Notes

No significant fiscal implication to the State is anticipated. 

Bill Analysis

HB 2185 would allow pharmaceutical manufacturers or their representatives to promote in their advertising directly to a physician or healthcare provider, a medically truthful and accurate off-label use of a drug, biological product or device. Physicians would then be allowed to communicate or promote this off-label use to a patient. HB 2185 would prevent a pharmaceutical manufacturer or representative from being prosecuted or subject to disciplinary action for promoting an off-label use. Health benefit plans would not be required to cover an off-label use. 

HB 2185 would prohibit Texas or a local governmental entity from using public money to enforce or to cooperate with the federal government in enforcing a law against a pharmaceutical manufacturer or its representative promoting an off-label use. 

Vote Recommendation Notes

HB 2185 represents an attempt to circumvent federal regulations which inhibit beneficial uses of prescription medication for uses other than those for which the FDA originally gave approval (21 U.S.C. Sections 331 and 335). This has a chilling effect which prevents doctors from prescribing medications for uses beyond their original FDA-approved purpose, depriving patients from the full benefit of those medications. 

HB 2185 promotes the principles of individual liberty, personal responsibility, the free market, private property rights, and limited government. Texas Action supports HB 2185.