MRA testified this morning on legislation in the Vermont legislature, S. 104, which would legalize research with physicians.
Current Vermont law and regulation -- Act 128 (2010), and 18 V.S.A. Sec. 4631a and 4632 -- are ambiguous, at best, on the legality of incentive payments for research with physicians sponsored by pharmaceutical and medical device manufacturers. That ambiguity has led manufacturers to avoid physician research studies with Vermont physicians. This is the case even though such payments are made through independent survey and opinion research companies and the manufacturers are not aware of which providers participated.
MRA testified on April 21 before the House Committee on Health Care, at the suggestion of the Assistant Attorney General, Wendy Morgan. MRA had previously met with her regarding Vermont’s regulations, because the Attorney General’s Office is the relevant enforcement body.
As introduced by the Senate Committee on Health and Welfare, S. 104 would add to the list of ��Allowable expenditures” in the law, “Other research paid at fair market value, as long as the manufacturer on behalf of which the survey or other research is conducted is unaware of the identity of the health care provider receiving expenditures related to the research.” While such incentive payments would not need to each be individually reported, manufacturers would still need to report, “for each research activity ...the number of health care providers participating in the research, the total amount paid to the entity conducting the research, and, if a product is distributed as part of the research, the product name, dosage, and number of units distributed.”
MRA supports the Senate version of S. 104 as a huge improvement over the current situation for incentives in Vermont. Though we have some concerns that any reporting requirements, even the aggregate required under this legislation, may still deter manufacturers from conducting research with physicians, based on experience in a state like West Virginia, our concerns are somewhat alleviated by Marjorie Powell, Senior Assistant General Counsel for PhRMA. Testifying just before MRA, she intimated that the reporting requirements in S. 104 would not pose a problem for pharmaceutical manufacturers. Should this legislation become law, MRA will seek to hold the pharmaceutical and medical device industry to that statement.
The members of the Health Care Committee appreciated MRA’s efforts to educate on the practice of marketing research. However, unlike the Massachusetts Department of Public Health, the Minnesota Board of Pharmacy, and Congress, these legislators seemed particularly interested in: (1) perfect double-blind research studies, in which the participating health care providers would have no way of knowing who might have sponsored a study; and (2) the exact dollar amounts of incentives paid to participating providers and whether sponsoring manufacturers could ever know such amounts.
The first presents an unattainable goal, since health care providers are not stupid and could infer from many studies who might be the sponsors. The only feasible route to satisfy such a standard would be to only allow incentives for studies that don’t mention or imply an actual product.
The second goal is not necessarily relevant. Moreover, research companies tend to not disclose their incentive payment structures, especially since incentives can vary dramatically by the type and length of the study, the specialty of the providers, whether the study involves a group or providers or a single in-depth-interview, and whether the study is conducted online, by phone or in-person.
S. 104 seems to have the momentum to be passed into law before Vermont’s legislative session ends next month. MRA will do what it can to help make that happen, as we have successfully in the past in Massachusetts (2009), Minnesota (2010), and the federal healthcare law (2010), and to advocate for and protect pharmaceutical marketing research with physicians.