Bill Text: NJ A2590 | 2012-2013 | Regular Session | Introduced
Bill Title: Requires Division of Consumer Affairs to publish list of certain tamper-resistant opioid drugs; establishes that certain conditions be met for pharmacist to substitute for tamper-resistant opioid drug.*
Spectrum: Slight Partisan Bill (Democrat 7-4)
Status: (Engrossed - Dead) 2012-06-25 - Received in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee [A2590 Detail]
Download: New_Jersey-2012-A2590-Introduced.html
Sponsored by:
Assemblyman DANIEL R. BENSON
District 14 (Mercer and Middlesex)
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington)
SYNOPSIS
Requires Division of Consumer Affairs to compile and publish list of certain tamper-resistant opioid drugs; establishes that certain conditions be met for pharmacist to substitute for tamper-resistant opioid drug.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning tamper-resistant opioid drugs and supplementing P.L.1977, c.240 (C.24:6E-1 et seq.).
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. The Legislature finds and declares that:
a. Prescription drug abuse is the fastest-growing drug problem in this nation, and data from the National Survey on Drug Use and Health show that nearly one-third of people aged 12 and over who used drugs for the first time in 2009 began with nonmedical use of a prescription drug;
b. The incidence of opioid abuse, in particular, has increased greatly in the United States in recent years and continues to rise;
c. Opioid overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers;
d. Studies show that addicts tend to crush or otherwise break down time-released products into a form that can be snorted or injected for a more intense high, and so formulations that make it more difficult to crush or otherwise manipulate those products may mitigate the potential for abuse;
e. Drug manufacturers have created novel technologies that may help deter the inappropriate use of opioid medications, and the federal Food and Drug Administration has afforded priority review to new drug applications for opioids incorporating such tamper resistance technologies; and
f. Given the critically important public health and law enforcement goals of preventing the abuse and misuse of opioids, it is manifestly in the public interest for the public policy of this State to encourage drug manufacturers to develop opioid products with tamper resistance technologies and thereby promote the efficient use of scarce health care resources.
2. a. (1) The Director of the Division of Consumer Affairs in the Department of Law and Public Safety shall compile and publish a list of opioid drugs approved by the federal Food and Drug Administration that incorporate tamper resistance technology which includes at least one human tampering or abuse-potential study, or a laboratory study comparing the tamper- or abuse-resistant properties of the drug to one or more opioid drugs that have been approved by the federal Food and Drug Administration and that serve as a positive control. The list shall include a determination by the director as to which of the listed opioid drugs incorporating tamper resistance technologies provide substantially similar tamper-resistant properties, based solely upon one or more studies submitted by the drug manufacturer pursuant to paragraph (2) of this subsection.
(2) It shall be the responsibility of the drug manufacturer to submit to the division such studies as are necessary to meet the requirements for listing by the division pursuant to paragraph (1) of this subsection. The director, no later than the 60th day following receipt thereof, shall notify the manufacturer of the director's determination as to whether the submitted study meets the requirements for listing. If the director determines that the study meets the requirements for listing, the division shall immediately update the list published pursuant to paragraph (1) of this subsection to include the drug.
(3) The Director shall establish, by regulation, the fees to be paid by a manufacturer that submits a study pursuant to paragraph (2) of this subsection, which fees shall be paid at the time the study is submitted. The fees shall be reasonable and shall not exceed an amount reasonably necessary to cover the cost of reviewing and publishing the list pursuant to paragraph (1) of this subsection.
(4) For the purposes of this section, "opioid drug" means a drug in the opioid drug class that is prescribed to treat moderate to severe pain or other conditions, whether in immediate release or extended release form, and whether or not combined with other drug substances to form a single dosage form.
b. Inclusion of a drug on the list published pursuant to paragraph (1) of subsection a. of this section shall not require that a drug bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential at the time it is listed pursuant to paragraph (1) of subsection a. of this section.
3. A pharmacist shall not substitute an opioid drug that is otherwise eligible for such substitution for another opioid drug, whether it is a brand name or generic drug product, that incorporates a tamper resistance technology and is included on the list published by the Division of Consumer Affairs pursuant to paragraph (1) of subsection a. of section 2 of this act, unless the pharmacist verifies that the substitute drug has been listed by the division as providing substantially similar tamper resistance technology prior to making the substitution. If the substitute drug is not included on the published list, the pharmacist shall obtain written, signed consent from the prescribing practitioner for such substitution.
4. This act shall take effect on the first day of the fourth month next following the date of enactment.
STATEMENT
This bill requires that the Director of the Division of Consumer Affairs (the division) in the Department of Law and Public Safety compile and publish a list of opioid drugs approved by the federal Food and Drug Administration that incorporate tamper resistance technology. "Opioid drug" is defined in the bill to mean a drug in the opioid drug class that is prescribed to treat moderate to severe pain or other conditions, whether in immediate release or extended release form, and whether or not combined with other drug substances to form a single dosage form.
The list is to indicate which opioid drugs on the list that incorporate tamper resistance technologies provide substantially similar tamper-resistant properties, based solely upon one or more studies submitted by the drug manufacturer in accordance with the requirements in the bill. The drug manufacturer would be responsible for submitting the studies to the division. No later than the 60th day following receipt of a study, the director is to notify the manufacturer of its determination as to whether the study meets the requirements for listing. If the director determines that the study meets the requirements for listing, the list is to immediately be updated to include that drug. Drugs included on the list would not be required to bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential at the time they are listed.
The director is to establish, by regulation, the fees to be paid by a manufacturer that submits a study. The fees are to be paid at the time the study is submitted to the director, and the fees are not to exceed an amount reasonably necessary to cover the cost of reviewing and publishing the list.
The bill also prohibits a pharmacist from substituting an opioid drug that is otherwise eligible for substitution, unless the pharmacist verifies that the substitute drug has been listed by the division as providing substantially similar tamper resistance technology prior to making the substitution. If the substitute drug is not on the list, the pharmacist is to obtain written, signed consent from the prescribing practitioner for such substitution.
The purpose of this bill is to reduce opioid abuse by ensuring that when a practitioner prescribes an opioid drug that incorporates tamper resistance technology, the pharmacy will not routinely substitute a drug lacking that technology.
