The FDA's regulation of health economic information

Section 114 of the Food and Drug Administration Modernization Act of 1997 w as intended to increase the flow of health economic information from pharma ceutical manufacturers to managed care decisionmakers. But the legislation raises a host of complex questions and has provoked diverse opinions from i nside and outside the pharmaceutical industry. Moreover, the Food and Drug Administration (FDA) has yet to issue interpretative guidance on the subjec t. The challenge in implementing Section 114 lies in developing a policy th at improves health economic information exchange while protecting consumers from misleading claims and preserving incentives for manufacturers to cond uct rigorous studies.