A leading research association testified at a hearing in New Jersey on October 19, 2017 about proposed regulations on payments to medical professionals, urging an exemption for pharmaceutical marketing research incentive payments.
"There is ample precedent for such an exemption at the state and federal level," including in the District of Columbia, Massachusetts, Minnesota, in the federal Physician Payments Sunshine Act, and most recently in California S.B. 790, as Howard Fienberg, Director of Government Affairs for the Insights Association, explained.
The Insights Association is the leading and largest nonprofit organization for the marketing research and analytics industry.
"Without an exemption," Fienberg said, the proposed regulations would restrict most pharma gifts and payments to "medical professionals licensed to prescribe drugs in New Jersey," raising costs and hurting respondent cooperation in pharmaceutical marketing research.
"While incentives to prescribers for participation in pharmaceutical marketing research might still be allowed by the proposed rules, the payments would presumably be counted towards the annual cap on each prescriber's annual consulting earnings, and research relationships with prescribers would be subject to a lot more legal paperwork. The ban on 'modest meals' would also presumably mean that providing food as part of an hours-long in-depth interview or focus group with prescribers would be verboten."
Such would be the case, he elaborated, despite makreting research incentives normally being "offered by independent marketing research companies," with the pharmaceutical manufacturers sponsoring the research "typically not aware of which practitioners participated." These incentives are "neither gifts designed to accrue influence, nor are they lavish. Rather, the payments are modest amounts (usually ranging from less than one hundred dollars to no more than a few hundred per study) paid to compensate the practitioners for their time. Moreover, these incentive payments are not determined on an ad hoc or willy-nilly basis, but are instead subject to rigorous “fair market value” analyses performed by both pharmaceutical manufacturers’ marketing research staff and their outside research company partners."
Even in the best interpretation, "where pharmaceutical compliance departments would assume that marketing research studies with prescribers would" be legal under the proposed regulations:
- "Research engagements would require more time-consuming paperwork, attestations, and legalistic formal contracts than may be typical right now, especially for low-dollar compensation arrangements, which will raise the cost of the research and make prescribers less likely to participate;"
- "Since the total incentive payments would count against an individual prescriber's total allowed compensation for the year, prescribers would be less likely to participate in research studies, and manufacturers less likely to want to sponsor research studies;"
- "Research companies would face yet another hurdle to respondent cooperation, since they wouldn't be able to know which respondents had received how much in total compensation for the year, and thus who would still be available for research participation;" and
- "Prescribers also might be deterred from participating because of the sensitivity in having to publicly disclose having received payments from the sponsor when they speak at an event, no matter how nominal, even though they did not learn the sponsor’s identity until later."
That potential deterrence is "key, since researchers would have to inform participating prescribers about who sponsored the research studies in which they participate, at least at the end, so that the prescribers could keep track of their payments, even though most studies specifically avoid such disclosure to avoid biasing the resulting insights." Fienberg argured that, "with so much research being double-blind," the regulatory proposal would "make the research process more complicated and possibly make marketing research incentive payments to prescribers more likely to influence their prescribing behavior, not less."
"Therefore," testified the Insights Association, "these regulations should exempt prescriber compensation for participation in 'bona fide marketing research' conducted by a third party, where such payments are made by that third party. This would affirmatively exclude payments for marketing research conducted by independent marketing researchers."
Should New Jersey fail to exempt marketing research from the proposed regulations, "prescribers in New Jersey may not be properly represented in research, leading to an inaccurate view of their and their patients’ needs, which will hinder the development and delivery of medicines and services to address unmet patient needs."
"Marketing research delivers insights to drive good decisions that fuel New Jersey's economic welfare and public health," Fienberg concluded, and it would be a shame to jeopardize that.