A Shift in the Regulatory Approach
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0092-8615l98 Copyright 0 1998 Drug Information Association Inc.
A SHIFT IN THE REGULATORY APPROACH JANET WOODCOCK, MD U.S. Food and Drug Administration, Rockville, Maryland
This paper highlights the shift in the Food and Drug Administration’s (FDA) approach to the off-label use of drugs, including definitions and a discussion of current policies, reasons for the changes, and current initiatives in off-label use. Off-label uses must be studied and effective uses should be labeled. FDA is adopting new strategies to get more uses on the label. Key Words: Off-label use; Food and Drug Administration; Promotion; Oncology; Pediatrics
REAL SHIFTS HAVE occurred in the United States Food and Drug Administration’s approach to off-label use of drugs. This paper presents three topics related to the agency’s evolving policy in this area: 1. A series of definitions and a brief discussion of current FDA policies, 2. Some of the changes in the environment that are stimulating the agency’s reevaluation of policies related to off-label use, and 3. Current FDA initiatives in the area of offlabel use and some potential future strategies. Off-label use can be defined as any indication, dosage form, dose regimen, population, or other parameter for use of a drug not mentioned in the approved labeling. Simply stated, any deviation from the use defined in the approved labeling is an off-label use-a
Presented at the DIA 33rd Annual Meeting “Optimizing Pharmaceutical Development: The Global Experience,” June 22-26, 1997, Montreal, Canada. Reprint address: Janet Woodcock, MD, U.S. Food and Drug Administration, FDA, Dir Center for Drug Evaluation, 5600 Fishers Lane, HFD-1, Rockville, MD 20857.
definition that extends beyond use for a nonlabeled indication. What are the FDA policies on off-label use? One much discussed policy is that pharmaceutical manufacturers or other manufacturers of medical products cannot proactively discuss off-label uses, nor may they distribute written material such as promotional pieces, or reprints of articles that mention off-label uses. FDA does not restrict any other party without a financial interest from discussing off-label uses or distributing written materials concerning them. The new schemes of health care delivery have created some blurring between pharmaceutical manufacturers and “other parties,” and so this particular issue is becoming more important. Doctors, pharmacists, and other health care professionals, however, can distribute or discuss off-label uses without any FDA intervention. The restriction applies only to pharmaceutical sponsors. FDA, at the same time, recognizes that off-label use of drugs by prescribers is a matter of tailoring the best possible therapy for an individual patient. Pertinent to the issue of reimbursement, the agency has stated that off-label use is often appropriate and may, indeed, represent the standard of practice.
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Janet Woodcock
Because medicine, in contrast to FDA-ap- Another concern is
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