New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45J - LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS › Subchapter 1 - LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS › Section 13:45J-1.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:
"Bona fide services" means those services provided by a prescriber pursuant to an arrangement formalized in a written agreement including, but not limited to, presentations as speakers at promotional activities and education events, participation on advisory boards, and consulting arrangements. "Bona fide services" does not include those services provided by a prescriber in connection with research activities. The written agreement shall specify the services to be provided, the dollar value of the consideration to be received by the prescriber, based on the fair market value of the services, specify that the meetings held in association with bona fide services occur in venues and under circumstances conducive to the services provided and that the activities related to the services are the primary focus of the meeting, and identify the following:
1. The legitimate need for services in advance;
2. The connection between the competence, knowledge, and expertise of the prescriber and the purpose of the arrangement;
3. How participation of the prescriber is reasonably related to achieving the identified purpose;
4. The manner by which the prescriber will maintain records concerning the arrangement and the services provided by the prescriber; and
5. An attestation that the prescriber's decision to render the services is not unduly influenced by a pharmaceutical manufacturer's agent.
"Consumer Price Index" means the annual average, rounded to the nearest dollar, of the Consumer Price Index for Food Away From Home--Northeast Urban, as posted in January for the preceding year by the U.S. Department of Labor Bureau of Labor Statistics at
http://www.bls.gov/
, or a successor index. To round, amounts under 50 cents shall be disregarded, and amounts of 50 cents or more shall be increased to the next dollar.
"Education event" means an education event, third-party scientific or educational conference, professional meeting or workshop, seminar, U.S. Food and Drug Administration required education and training, or any other gathering held in a venue that is appropriate and conducive to informational communication and training about healthcare information, including information about disease states and treatment approaches, where:
1. The gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering); and
2. The main purpose for bringing attendees together is to further their knowledge on the topic(s) being presented.
Notwithstanding the Food and Drug Administration's classification of a program as promotional, programs that meet the definition of "education event" shall be deemed an "education event" for purposes of this chapter.
"Modest meals" means a food and/or refreshment, where its fair market value does not exceed $ 15.00 (for breakfast or lunch) or $ 30.00 (for dinner), in 2018, for each prescriber. In each succeeding calendar year after 2018, these amounts shall be adjusted if the Consumer Price Index reflects a sum, which, if rounded, consistent with the definition of "Consumer Price Index," would raise it by one dollar increments. The fair market value shall not include the cost of standard delivery, service, or facility rental fee charges, or of tax.
"Non-faculty" means a prescriber who does not serve as a speaker or provide actual and substantive services as a faculty organizer or academic program consultant for an education event or for a promotional activity.
"Pharmaceutical manufacturer" means any entity that:
1. Is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs or biologics, by extraction from substances of natural origin, or independently by means of chemical synthesis; or
2. Is directly engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs or prescription biologics, provided, however, that "pharmaceutical manufacturer" or "manufacturer" shall not include a healthcare facility licensed by the Department of Health, or a pharmacy holding a permit issued by the Board of Pharmacy.
"Pharmaceutical manufacturer's agent" or "manufacturer's agent" means a person who, while employed by, or under contract with, a pharmaceutical manufacturer, engages in detailing, promotional activities, or other marketing of prescription drugs or biologics to any prescriber authorized to prescribe, dispense, or purchase prescription drugs, biologics, healthcare facility, or pharmacist, but shall not include a prescriber or pharmacist when acting within the ordinary scope of the practice for which he or she is licensed.
"Prescriber" means a physician, podiatrist, physician assistant, advanced practice nurse, dentist, or optometrist who has an active license pursuant to Title 45 of the Revised Statutes. "Prescriber" does not include a licensee who is an employee, as defined in N.J.A.C. 18:35-7.1, of a pharmaceutical manufacturer who does not provide patient care.
"Promotional activity" means any unaccredited activity, meeting, or program organized or sponsored by a pharmaceutical manufacturer, or the manufacturer's agent, that is directed at prescribers to promote the prescription, recommendation, supply, administration, use, or consumption of the manufacturer's products through any media or medium. "Promotional activity" does not include an education event or services provided in connection with research activities.
"Research" means any study assessing the safety or efficacy of prescribed products administered alone or in combination with other prescribed products or other therapies, or assessing the relative safety or efficacy of prescribed products in comparison with other prescribed products or other therapies, or any systematic investigation, including scientific advising on the development, testing, and evaluation, that is designed to develop or contribute to general knowledge, or reasonably can be considered to be of significant interest or value to scientists or prescribers working in a particular field. "Research" shall include both pre-market and post-market activities that satisfy the requirements of this definition.