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HHS INSPECTOR GENERAL’s WORK PLAN FOR FISCAL 1991 INCLUDES REVIEW OF DIRECT-TO-CONSUMER ADVERTISING AND FDA’s ORPHAN DRUG APPROVAL PROCEDURES

Executive Summary

The HHS Office of the Inspector General plans to conduct a review of direct-to-consumer prescription drug advertising in early 1991, according to a draft work plan for fiscal years 1990 and 1991. The study "will analyze the range and nature of prescription drug advertising; its effect on decisions made by consumers to visit physicians and request or demand advertised treatments or drugs; and its effect on drug pricing," the document states. The review will be conducted by the IG's Office of Analysis and Inspections, the IG arm responsible for analyzing HHS programs and policies. Although the IG work plan is a draft that is subject to extensive revision as the year progresses and new priorities emerge, the planned investigations reflect the IG's current interests and areas that may become hot issues in HHS and Congress, if they're not already. Another topical area of investigation slated for review by the IG next year is the Orphan Drug Act. The IG's Audit Office, which provides policy direction for HHS programs and operations as well as conducting comprehensive audits, is expected to begin its review of FDA Orphan Drug Act approval procedures in the third quarter of 1991 (fourth quarter of the government's fiscal year). The purpose of the review, according to the draft work plan, "is to determine whether necessary clinical and nonclinical investigations have been conducted prior to approving a product as an orphan drug." Other planned IG projects include a review of the adequacy of funding for AZT, scheduled for the fourth quarter of fiscal 1990; a review of utilization and pricing issues raised by Medicare use of erythropoietin, scheduled for the fourth quarter of fiscal 1990; and a review of prescription drug reimbursement programs to see if the government is taking advantage of available savings, which is planned for the fourth quarter of fiscal 1991.

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