Regulations adopted by the New Jersey Attorney General Division of Consumer Affairs titled LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS became effective last week. These Regulations provide the rules under which prescribers may receive anything of value from pharmaceutical and biologics manufacturers. ‘Prescribers’ is defined to include a licensed physician, podiatrist, physician assistant, advanced practice nurse, dentist, or optometrist.
The Regulations prohibit a prescriber from accepting from a pharmaceutical manufacturer or its agent any financial benefit or benefit-in-kind including, but not limited to, gifts, payments, stock, stock options, grants, scholarships, subsidies, and charitable contributions, except as permitted by the Regulations. Prescribers also may not accept entertainment or recreational items, items with a company or product logo, items for the personal benefit of the prescriber or office staff, cash or cash equivalents (e.g., gift certificates), payments or direct subsidies for non-faculty prescribers to attend educational or promotional activities, and meals over $15.
Permitted gifts and payments under the Regulations include items designed primarily for patient or prescriber educational purposes, certain subsidized registration fees and meals at education events, modest meals in connection with a promotional event with a fair market value of $15 or less per prescriber, fair market value compensation and related travel expenses for bona services provided as a speaker or consultant in connection with an education event, fair market value compensation and related travel expenses for bona services provided as a speaker or consultant in connection with an promotional activity up to an aggregate amount of $10,000 per calendar year from all pharmaceutical manufacturers, reasonable payment and related travel expenses for research activities and employment recruitment, and royalties or licensing fees paid in connection with a prescriber’s ownership rights. Prescribers also may accept product samples intended to be used exclusively for the benefit of the prescriber’s patients.
Written agreements between pharmaceutical manufacturers and New Jersey prescribers will be required to contain the following information, as specified in the Regulations:
- Describes the services to be provided;
- States the fair market value consideration to be received by the prescriber;
- Specifies 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;
- Identifies the legitimate need for services in advance;
- Identifies the connection between the competence, knowledge, and expertise of the prescriber and the purpose of the arrangement;
- Identifies how participation of the prescriber is reasonably related to achieving the identified purpose;
- Identifies the manner by which the prescriber will maintain records concerning the arrangement and the services provided by the prescriber; and
- Attestation that the prescriber’s decision to render the services is not unduly influenced by a pharmaceutical manufacturer’s agent.
We will continue to monitor developments related to the New Jersey Regulations and provide updates as they develop.