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Editorials |

Off-Label Use of Approved Drugs

Laurence Landow, MD (Boston, MA)
Author and Funding Information

Dr. Landow is a member of the Department of Anesthesiology, Perioperative & Pain Medicine, Brigham & Women’s Hospital.

Correspondence to: Laurence Landow, MD, Department of Anesthesiology, Perioperative & Pain Medicine, Brigham & Women’s Hospital, Boston, MA 02115; e-mail: landow@zeus.bwh.harvard.edu



Chest. 1999;116(3):589-591. doi:10.1378/chest.116.3.589-a
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Throughout the 1980s and continuing into the 1990s, drug pipelines in the biotechnology and pharmaceutical sectors expanded at an unprecedented rate. To expedite the safety and efficacy assessment of these products by the Food and Drug Administration (FDA), the 105th Congress passed the FDA Modernization Act of 1997.

Section 401 of the Act permits drug manufacturers to disseminate reprints of journal articles reporting “off-label” use—unapproved indications, populations, doses, or routes of administration for marketed drugs—directly to the medical community. Recently, the Department of Health and Human Services (HHS) issued a final rule1 (regulation) that outlines how Section 401 will be implemented. The purpose of this commentary is to briefly outline some of its features and to discuss its potential effect on patient safety.

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