Bill Text: NJ A2997 | 2016-2017 | 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: Moderate Partisan Bill (Democrat 8-1)
Status: (Introduced - Dead) 2016-02-16 - Introduced, Referred to Assembly Consumer Affairs Committee [A2997 Detail]
Download: New_Jersey-2016-A2997-Introduced.html
Sponsored by:
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington)
SYNOPSIS
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.
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. The Director of the Division of Consumer Affairs in the Department of Law and Public Safety shall publish on the division website a list of opioid drugs approved by the federal Food and Drug Administration that incorporate tamper resistance technology, as demonstrated by at least one human tampering or abuse-potential study. The director shall include on the list only those opioid drugs for which the manufacturer submits an application that conforms to the requirements of subsection b. of this section.
b. (1) The application submitted by the manufacturer of an opioid drug pursuant to subsection a. of this section shall include a report from a testing laboratory that is accredited by:
(a) the American Association for Laboratory Accreditation;
(b) the International Organization for Standardization as an ISO 17025:2005 or later testing laboratory; or
(c) a nationally recognized agency that complies with the current good manufacturing practice requirements of the federal Food and Drug Administration pursuant to 21 C.F.R. s.210.
(2) The testing laboratory shall not, although retained or commissioned by the manufacturer to produce the required report, otherwise be affiliated with or subject to the control of the manufacturer and shall not be the same entity that conducted or produced the human tampering or abuse-potential study relied upon in subsection a. of this section.
(3) The report by the testing laboratory shall confirm that the opioid drug for which an application for listing is being made:
(a) is interchangeable with another opioid drug approved by the federal Food and Drug Administration, whether it is a brand name or generic drug product;
(b) incorporates tamper resistance technology, as demonstrated by at least one human tampering or abuse-potential study determined to be valid by the laboratory; and
(c) incorporates tamper resistance technology in the same dosage form as the tamper resistance technology of the drug with which it is interchangeable.
c. The director shall include an opioid drug on the list that is published on the division website solely on the basis of the laboratory report required pursuant to subsection b. of this section.
d. The manufacturer shall bear all costs of the laboratory report.
e. The director shall establish, by regulation, the application fee to be paid by a manufacturer that submits an application pursuant to subsection a. of this section, which fee shall be paid at the time the study is submitted. The fee shall be reasonable and shall not exceed an amount reasonably necessary to cover the cost of reviewing and publishing the list pursuant to subsection a. of this section.
f. 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.
g. The inclusion of a drug on the list published pursuant to 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.
3. a. A pharmacist shall not substitute an opioid drug that is included on the list published by the Division of Consumer Affairs pursuant to subsection a. of section 2 of this act with a drug that is not included on the list.
b. Subject to the provisions of section 8 of P.L.1977, c.240 (C.24:6E-7), a pharmacist may substitute an opioid drug that is included on the published list with another drug that is on the list and is otherwise interchangeable, whether it is a brand name or generic drug product, provided that the pharmacist verifies, prior to making the substitution, that the substitute drug is included on the published list and is identified on the published list as incorporating tamper resistance technology in the same dosage form as the tamper resistance technology of the drug for which it is to be substituted.
c. If the prescription does not specify an opioid drug that is included on the published list, the provisions of subsections a. and b. of this section shall not apply.
4. This act shall take effect on the first day of the fourth month next following the date of enactment.
STATEMENT
This bill requires the Division of Consumer Affairs (DCA) in the Department of Law and Public Safety to publish a list of opioid drugs approved by the federal Food and Drug Administration (FDA) that incorporate tamper resistance technology, with the purpose of ensuring that when practitioners prescribe an opioid drug that incorporates tamper resistance technology, pharmacies will not routinely substitute a drug lacking that technology.
Under current law, the Department of Health promulgates a list of interchangeable drug products. Pharmacies are permitted to substitute a drug product of a different brand name or a nonbrand name from this list in place of the drug specified on the prescription, provided that the prescription authorizes substitutions and the substitute drug product represents a cost savings to the consumer. This bill requires that, prior to making a substitution, pharmacists must additionally consult the DCA list to ensure that an opioid drug incorporating tamper resistance technology is not substituted by an opioid drug that does not incorporate the technology.
To be included on the DCA list, a drug manufacturer must submit an application that includes a report from an accredited testing laboratory confirming the drug: (1) is interchangeable with another FDA-approved opioid drug; (2) incorporates tamper resistance technology as established by at least one human tampering or abuse-potential study determined to be valid by the testing laboratory; and (3) incorporates the tamper resistance technology in the same dosage form as the tamper resistance technology of the drug with which it is interchangeable. The testing laboratory cannot be affiliated with or subject to the control of the manufacturer, and cannot be the same entity that conducted or produced the human tampering or abuse-potential study. The manufacturer is required to bear the costs of the laboratory report.
The DCA list will include opioid drugs solely on the basis of the laboratory report submitted with the manufacturer's application. The bill does not require that a drug included on the list bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential.
The director of the DCA will establish, by regulation, a reasonable application fee that does not exceed the cost of reviewing and publishing the DCA list.
Under the bill, pharmacists may not substitute a drug included on the DCA list with a drug that is not included on the list, and may only substitute one drug on the list with another drug on the list if the substitute drug includes tamper resistance technology in the same dosage form as the drug for which it is to be substituted. The bill does not apply if the prescription does not specify an opioid drug included on the DCA list.
