New regulations in New Jersey restricting interactions between medical professionals and pharmaceutical manufacturers should not impede marketing research, thanks to the advocacy of the Insights Association, the leading nonprofit association representing the marketing research and analytics industry.
The new regulation, "Limitations on and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers" (N.J.A.C. 13:45J), will prohibit a variety of gifts and payments from pharmaceutical manufacturers to any medical professionals licensed to prescribe drugs in New Jersey, with many allowed payments capped per prescriber per annum, and limitations on other aspects of interactions.
In response to the initial regulatory proposal, the Insights Association testified at a regulatory hearing in Newark, New Jersey on October 19, 2017, in defense of pharmaceutical marketing research and incentives. A dozen witnesses testified at the hearing and a further 56 submitted written comments as part of the proceeding. In particular, BioNJ, a New Jersey life sciences association, also commented that marketing research should be treated differently.
In addition, Insights Association member Steve Schlesinger (Schlesinger Associates) arranged a productive meeting for us with Attorney General Christopher Porrino and Consumer Affairs Division Director Sharon Joyce.
[See the photo atop this article featuring Steve Schlesinger on the left and AG Porrino on the right.]
Carveout for independent pharmaceutical marketing research
State and federal regulation often treats marketing researchers as an extension of their pharmaceutical manufacturer clients, and incentive payments for participation in research studies as payments “from” the manufacturer clients. However, heeding our concerns, the AG clarified that, “To the extent that a market research company does not engage in detailing, promotional activities, or other marketing of prescription drugs or prescription biologics, by definition a market research company is not considered a pharmaceutical manufacturer’s agent.”
Therefore, pharmaceutical marketing research with prescribers receiving respondent incentives should be exempt from these new rules, as long as the research is conducted by a marketing research company that is independent of a pharmaceutical manufacturer.
Research and analytics conducted by a manufacturer themselves would still be subject to the rules.
New Jersey’s new pharma rules
Many commenters, including the Insights Association, supported the AG’s stated intent to combat opioid abuse, but worried that the proposed rules would not only not accomplish that goal, they would also have a dramatically bigger impact beyond just opioid drugs.
The Attorney General responded that he fully intended the new regulations to “apply to all prescription medications, so as to ensure that patient care is guided by the unbiased, best judgment of the treating prescriber” and “strengthen enforcement efforts to address prescriber acceptance of items of value from drug manufacturers.”
“The Attorney General did not intend for the proposed rules at N.J.A.C. 13:45J to include research activities and clinical trials,” however, so he provided exemptions.
“Bona fide services,” subject to the $10,000 aggregate cap on payments to a prescriber, among other restrictions, now “does not include those services provided by a prescriber in connection with research activities,” and “promotional activity” excludes “an education event or services provided in connection with research activities.” “Research” is defined as “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 systemic 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.” The term also includes “both pre-market and post-market activities that satisfy the requirements of this definition.”
A prescriber is also now allowed to accept “reasonable payment or remuneration for travel, lodging, and other personal expenses in connection with research activities” from “a pharmaceutical manufacturer or manufacturer’s agent.”
If you are a marketing research department within a pharmaceutical manufacturer conducting research with prescribers directly, these research carveouts may only cover a (potentially small) portion of your research studies. The rest of your studies would have to abide by the significant restrictions placed on bona fide services agreements.
The new rules “apply to all New Jersey licensed prescribers regardless of where the bona fide services are provided.” This includes physicians, podiatrists, physician assistants, advanced practice nurses, dentists, and optometrists.
The regulation applies to any contracts “that are entered into, and any conduct that occurs on or after, … January 16, 2018, the effective date of these rules.”
See the full comments, responses and final regulation changes.