OIG to evaluate rep gift-giving

The Office of Inspector General for the United States Health and Human Services Administration plans to evaluate the extent of pharmaceutical sales representative gift-giving in 2002, according to its recently released "Fiscal Year 2002 Work Plan."

In 1990, the Food and Drug Administration passed regulations prohibiting pharmaceutical companies from giving "gifts of substantial value" to physicians. According to the OIG, however, the pharmaceutical industry spends roughly $12 billion per year marketing pharmaceuticals to physicians. "Some of these gifts may present an inherent conflict of interest between the legitimate business goals of manufacturers and the ethical obligation of providers to prescribe drugs in the most rational way," read the 2002 plan. "Gifts may also violate the federal anti-kickback statute if they are intended to induce referrals."

Representative gift-giving has been coming under increased scrutiny lately. In August, the American Medical Association announced that it had created a working group to educate doctors on gift-giving guidelines and urge both physicians and pharmaceutical industry representatives to comply with them.

Other initiatives

In addition to the gift-giving initiative, the Office of Inspector General is planning to review the effects of the Prescription Drug User Fee Act on "the regulatory review of new drug applications" and identify processes and programs that can improve the effectiveness and stringency of the review process. The OIG will also examine the FDA's practices regarding post-marketing studies of prescription drugs. PR