Sponsored by:
Assemblyman PARKER SPACE
District 24 (Morris, Sussex and Warren)
SYNOPSIS
Prohibits manufacture, sale, and prescription of certain monitoring devices in certain drug products that contain monitoring devices.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning prescription drug products and supplementing P.L.1960, c.39 (C.56:8-1 et seq.).
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. a. For the purposes of this section:
“Drug product” shall have the same meaning as set forth in subsection a. of section 5 of P.L.1977, c.240 (C.24:6E-4).
“Ingestible device” means an ingestible event marker, as that term is defined in 21 CFR s.880.6305, or any other type of microchip embedded or otherwise affixed to a prescription drug product meant to provide electronic monitoring following ingestion by a person.
“Prescription” shall have the same meaning as set forth in subsection d. of section 5 of P.L.1977, c.240 (C.24:6E-4).
b. A person shall not manufacture, sell or otherwise distribute, or prescribe in this State a prescription drug product that contains an ingestible device.
2. It shall be an unlawful practice and a violation of P.L.1960, c.39 (C.56:8-1 et seq.) to violate the provisions of section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).
3. This act shall take effect on the first day of the fourth month next following the date of enactment.
STATEMENT
This bill prohibits the manufacture, sale, distribution, or prescription of a prescription drug that can provide electronic monitoring of the patient who ingested the drug.
Under the bill’s provisions, it is a violation of the State’s consumer fraud act to manufacture, sell, distribute, or prescribe in this State a prescription drug product that contains an ingestible device. The bill defines an “ingestible device” to mean an ingestible event marker, as that term is defined in federal regulation or any other type of microchip embedded or otherwise affixed to a prescription drug product meant to provide electronic monitoring following ingestion by a person.
As provided in the bill, a person who violates these provisions commits unlawful practice pursuant to the State’s consumer fraud act. An unlawful practice is punishable by a monetary penalty of not more than $10,000 for a first offense and not more than $20,000 for any subsequent offense. Additionally, a violation can result in cease and desist orders issued by the Attorney General, the assessment of punitive damages, and the awarding of treble damages and costs to the injured.