Though many researchers may not have known it, there was a reason to cheer when President Obama signed the Patient Protection and Affordable Care Act into law in March.

Thanks to the efforts of the Pharmaceutical Marketing Research Group (PMRG), a trade association representing pharmaceutical and medical device manufacturers and their marketing research consultants, the health care bill included a modified version of the Physician Payment Sunshine Act (PPSA) - which was intended to shed light on the financial relationships and potential conflicts of interest between physicians and the pharmaceutical and medical device industries - that effectively excludes the honoraria that are usually paid to doctors for taking part in scientific survey and marketing research from the Sunshine Act’s reporting requirements.

As detailed in PMRG press materials, the PPSA requires disclosure of payments or gifts of value from pharmaceutical and medical device companies to physicians. Disclosure is to be reported to the Department of Health and Human Services, which in turn will post on a public Web site how much was paid to specific physicians by specific manufacturers.

In its original wording, the PPSA contained language that could have (albeit likely unintentionally) included public reporting of survey honoraria paid to physicians.

The PMRG argued that the public reporting of survey honoraria would not only chill and skew important health care survey research but would facilitate the very marketing abuses that the PPSA was intended to eliminate by revealing the names of surveyed physicians to pharmaceutical and medical device manufacturers.

In a press statement, PMRG Government Affairs Chair Bill Little said, “Our concern was that survey and marketing research was not originally granted an exclusion from the disclosure requirement. After all, the purpose of survey and marketing research is to understand the opinions, beliefs and behaviors of populations, including physicians, on various subject matters - not to influence them to behave in any way. As originally written, the PPSA seemed to require incentives paid for participation in research studies to be disclosed publicly. Public disclosure would have adversely impacted our ability to recruit physician respondents, potentially biased the responses of physicians whom we did recruit, and advertised to manufacturers the otherwise anonymous identities of survey participants.”

Undermine the integrity

The PMRG began working in the spring of 2009 to hold meetings with Senate and House staff members to explain how survey and marketing research differs from marketing, the important roles that survey and marketing research serve in medicine, and how the PPSA, as drafted, would undermine the integrity of survey and marketing research with physician respondents.

PMRG successfully introduced language into the act that excludes marketing research from the public disclosure requirements, as long as the honoraria are paid by manufacturers through third parties (e.g., survey and marketing research consultants) and the manufacturers do not know the identities of participating physicians.

PMRG was supported in its advocacy by the Marketing Research Association and Council of American Survey Research Organizations.

Establish a guideline

The PMRG press materials note that its win in Congress will not necessarily preclude states from enacting laws that include the reporting of survey and marketing research honoraria within their own versions of the PPSA. PMRG believes, however, that the federal act, at a minimum, will establish a guideline for state legislators and regulatory agencies in this realm.

“Understandably the intent of the PPSA is to diminish improper marketing practices on the part of manufacturers by requiring public disclosure of physician payments and potential conflicts of interest,” said Debbie Kossman, president of the PMRG, in a press statement. “Survey and marketing research, however, is not a tool to influence research participants to think or behave in any way, and confidentiality ensures that there is no potential for undue influence of a pharmaceutical manufacturer on physicians. We are very pleased that our organization’s efforts have succeeded at safeguarding the confidentiality of physician respondents and the integrity of survey and marketing research.”