Responding to objections from New Jersey healthcare practitioners, hospitality and restaurant businesses, and the pharmaceutical industry, the New Jersey Attorney General published an amendment to the state’s rules restricting the acceptance of remuneration by prescribers from pharmaceutical manufacturers. The final amendment, which appeared in the May 6 New Jersey Register and immediately became effective, relaxes some of the restrictions in the original rule (see our post on that rule here.) Following are the significant changes from the original rule:
- Meals at Education Events: The original regulation permitted prescribers to accept “modest meals” provided through the event organizer at an education event, and a “modest meal” was defined as one with a fair market value of $15 or less. The $15 limit has been removed. In addition, the amendment clarifies that an education event includes an event that focuses on disease states and treatment approaches, and also includes an event that that meets the rule’s definition of “education event” even if FDA classifies that event as promotional.
- Promotional Programs: The prior rule on accepting modest meals provided by drug manufacturers during promotional activities remains in place and is still capped at $15 for lunch, but the cap on dinners has been increased from $15 to $30 (adjusted for inflation after 2018). Also, the previous limit of four such meals per year has been removed.
- Bona Fide Service Fees: The Attorney General rejected recommendations that the existing cap on bona fide service fees accepted from all pharmaceutical manufacturers during any year be increased from the current $10,000. Fees for research and for speaking at education events continue to be exempt from this cap, and the preamble clarifies that research includes both pre-market and post-market research.
- No application to devices: The regulation continues to apply only to gifts and payments from pharmaceutical manufacturers, but a helpful clarification has been added that the rules do not apply to prescribers’ interactions with pharmaceutical manufacturers that also manufacture medical devices if the interactions are directly solely to medical devices.