ROPES & GRAY
Compliance History
• OIG Compliance Program Guidance for
Pharmaceutical Manufacturers (May 5, 2003)
• Clinical Trial Sponsorship: Manufacturers often contract with purchasers of their products to
conduct research activities on behalf of the manufacturer on a fee-for-service basis. These
contracts should be structured to fit in the personal services safe harbor whenever possible.
Payments for research services should be fair market value for legitimate, reasonable, and
necessary services. Post-marketing research activities should be especially scrutinized to
ensure that they are legitimate and not simply a pretext to generate prescriptions of a drug.
Prudent manufacturers will develop contracting procedures that clearly separate the
awarding of research contracts from marketing. Research contracts that originate through the
sales or marketing functions--or that are offered to purchasers in connection with sales contacts--
are particularly suspect.
• Research Grants for Investigator-Initiated Research: Pharmaceutical manufacturers
sometimes provide funding to their purchasers for use in the purchasers' own research. In many
cases, the research provides valuable scientific and clinical information, improves clinical care,
leads to promising new treatments, promotes better delivery of health care, or otherwise benefits
patients. However, as with educational grants, if linked directly or indirectly to the purchase of
product, research grants can be misused to induce the purchase of business without triggering
Medicaid Best Price obligations. To reduce risk, manufacturers should insulate research grant
making from sales and marketing influences.
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