The Association of Clinical Research Professionals today sent the following letter expressing concern over a proposed New Jersey rule that could have a chilling effect on clinical trials.
We write today to express concern about the proposed “Limitations on and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers and Prescribers” rule (N.J.A.C. 13:45J).
New Jersey lawmakers may be trying to ensure prescribers are not influenced inappropriately by payments from pharmaceutical companies, but this law could have unintended consequences on the advancement of medicine by hampering clinical trials across the state.
As written, this rule could have the unintended consequence of doing more harm than good.
Section 6 of the rule states: “A prescriber shall not accept more than $10,000 in the aggregate from all manufacturers in any calendar year for other bona fide services of presentations as speakers at promotional activities, participation on advisory boards and consulting arrangements. Payments for speaking at continuing education events are not subject to this cap, but must be for fair market value and set forth in a written agreement.”
The issue at hand is that the above are listed as generally the only permitted payments allowable, so absent clarity, there is danger that this cap or prohibition may, intentionally or unintentionally, include payments for clinical trials.
If it is the intention to include clinical trial-related payments, it would have a devastating impact on jobs and patient outcomes in the State of New Jersey. We know the Open Payments website shows large numbers affiliated with physicians who serve as principal investigators for clinical trials, but we also know that the database can be easily misread to give the appearance that the physicians actually receive that money, when most of it is for clinical trial-related expenses and the physicians themselves generally see very little of that amount, if any.
On behalf of the Association of Clinical Research Professionals’ 13,000-plus members, including more than 400 in the State of New Jersey, we respectfully urge clarification in the proposed rule to make fair market value payments for clinical trials an explicit exclusion, just as speaking fees were made an exclusion.
Thank you for your consideration.
ACRP Executive Director
If you or your organization want to provide feedback, individuals are free to 1) submit written comments to Maryann Sheehan, Director of Legislative and Regulatory Affairs, New Jersey Division of Consumer Affairs, Post Office Box 45027, 124 Halsey Street, 7th floor, Newark, N.J. 07101, no later than October 10, 2017, and/or 2) attend the public hearing at 10:30 a.m. Thursday, October 19, 2017, in the Monmouth Room at the Division of Consumer Affairs, 124 Halsey Street, 7th floor, Newark, N.J. 07101.