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Measure Would Apply to Prescription Drugs Carrying FDA 'Black Box Warning' Labels
(TRENTON) - Legislation Assemblyman Patrick J. Diegnan, Jr., sponsored that would require physicians and other licensed healthcare professionals to obtain informed consent from a parent or guardian before prescribing a potentially dangerous drug to a child was released by an Assembly committee today.
"This safeguard will ensure that a child's drug treatment plan does not become a prescription for disaster," said Diegnan (D-Middlesex).
The Diegnan bill (A-4245) would require physicians, advanced practice nurses, and other authorized prescribers to obtain informed consent from parents or guardians of minors prior to prescribing psychotropic medications that carry a federal Food and Drug Administration (FDA) "black box warning" label, including medicines designed to treat attention deficit disorder (ADD) and attention deficit and hyperactivity disorder (ADHD).
"Black box warning" labels are required to be placed on prescription packaging when medical studies show the drug in question carries with it a significant risk of serious or life-threatening adverse effects. A "black box warning" is the strongest advisory the FDA can place on prescription medication.
Medical practitioners who fail to obtain parental informed consent would be subject to disciplinary action by the applicable state professional licensing board. The measure would take effect six months after enactment.
The measure was released from the Assembly Consumer Affairs Committee by a 4 to 0 vote. It now heads to the Assembly Speaker, who decides if and when to post it for a floor vote.
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