• The OIG Issues Advisory Opinion Regarding Direct Mail Physician Surveys Conducted by an Independent Marketing Firm on Behalf of Pharmaceutical Manufacturers
  • June 11, 2004 | Authors: Wendy C. Goldstein; Cathleen G. Cachero
  • Law Firm: Epstein Becker & Green, P.C. - New York Office
  • In Advisory Opinion No. 04-03 ("Opinion"), issued on May 21, 2004, the Office of the Inspector General ("OIG") determined that it would not impose administrative sanctions on a marketing firm that, on behalf of pharmaceutical manufacturers, solicits responses to survey questions from physicians by placing such questions on the backs of one dollar checks made payable to individual physicians.

    The Opinion was requested by a marketing firm that enters into written agreements with pharmaceutical manufacturers to design, develop and implement physician surveys. The marketing firm represented to the OIG that the surveys contain four to six product-specific questions aimed at ascertaining physician opinions regarding drug labeling and the content and format of product information. According to the Opinion, the surveys also may include additional information about the pharmaceutical manufacturer, such as its website address, links to press articles and patient resources. The marketing firm further represented that during a one-year time period, it is hired to create 6 - 12 surveys for 2 - 4 different manufacturer clients. These clients provide the physician contact information to the marketing firm. At the conclusion of the survey, the marketing firm provides the pharmaceutical manufacturer with aggregate, non-physician-specific survey data, and if a physician indicates that he or she wishes to receive product information or materials, the physician's request is sent to the pharmaceutical manufacturer without the physician's survey responses. In accordance with the written agreement, the pharmaceutical manufacturer pays the marketing firm for the costs associated with conducting the surveys.

    After describing its frequently articulated concerns with arrangements in which a pharmaceutical manufacturer provides remuneration, directly or indirectly, to physicians, the OIG declined to impose administrative sanctions on the marketing firm because of certain unique facts and circumstances which "reflect a number of safeguards that mitigate the risk of fraud or abuse or otherwise merit consideration." First, the maximum amount that a physician would receive under the proposed arrangement is twelve dollars annually. Additionally, the marketing firm represented that it employs certain safeguards to ensure that a physician receives no more than twelve surveys per year on behalf of one or more manufacturer clients, and that the pharmaceutical manufacturers provide no other payments to the physicians through the marketing firm. Second, the nature and limited scope of the survey instrument further reduce the risk that the survey is meant to influence physicians' prescribing practices and the pharmaceutical manufacturers are not able to identify specific physicians' responses. Third, the marketing firm "has no discernible ability to influence referrals of business for its pharmaceutical company clients" because it is not a health care provider or supplier and does not have any patient contact or contact with the physicians other than the survey. Fourth, the feature of requiring the physician to endorse the check/survey "enhances the integrity of the survey program by safeguarding against individuals other than the physician completing the survey."

    Advisory Opinion No. 04-03 can be found on the OIG website at http://oig.hhs.gov/fraud/docs/advisoryopinions/2004/ao0403.pdf