The Office of the Inspector General (OIG) has indicated in its Compliance Program Guidance for Pharmaceutical Manufacturers that the provision of a study drug freeof-charge and/or funding for an investigator-initiated study is not per se prohibited under federal fraud and abuse laws, so long as the study is for a legitimate scientific purpose and the funding is tied to legitimate study costs. See 68 Fed. Reg. 23731 (May 5, 2003). In other words, the study cannot be a sham such that it serves, for example, simply as a vehicle to reward either high-volume on-label prescribing practitioners or key opinion leaders on the off-label use of the manufacturer’s drug. In the OIG’s view, the legitimacy of the study and the funding may be suspect if the marketing division of the pharmaceutical company is the driving force and decision-maker on whether to support the study. Consequently, you should ensure that your request for support is reviewed and approved by the medical/clinical component of the pharmaceutical company. It may also benefit both you and the pharmaceutical company if the study undergoes scientific review by a third party; this will help support the legitimacy of the study. Many research institutions have a scientific review committee, so if you are affiliated with an institution that has such a committee, it may be worth pursuing. Indeed, some institutions require scientific review of investigator-initiated studies. As for the trip to Paris, it too must pass the ‘legit’ test. As is true with respect to remuneration you receive from any entity to which you refer health care business, you must be very careful that the remuneration is not payment for referrals in fact or in appearance. You must ensure the remuneration is fair market value for legitimate services rendered or otherwise is a valid component of implementing a legitimate investigator-initiated research study. Consequently, if (1) you legitimately need to meet in Paris because it is a central location convenient for all of the other researchers and because it is where the company’s clinical/medical representatives are convening (not because you told the sales representative that you always wanted to go there); (2) you actually meet and discuss your protocol with company representatives and the other researchers; and (3) the expenses paid are reasonable and not lavish, it should be acceptable for the company to fund the portion of your trip related to the business conducted with the company and other researchers. This means it is not appropriate for the company to pay for lodging and expenses for 10 days when your meeting will conclude in two days, nor should you accept any payment to cover your husband’s expenses.
