Citation

Baker R. BETA 1998; 1998(Jul): 8-9.

Copyright

(Copyright © 1998, San Francisco AIDS Foundation)

DOI

unavailable

PMID

11365570

Abstract

The Food and Drug Administration (FDA) is establishing new rules that will enable manufacturers of FDA-approved drugs and medical devices to disseminate information regarding off-label or alternative uses of their products to the healthcare community, insurers, and government agencies. However, this information would not be disseminated to patients or the media. The off-label use would need to be documented in a reputable scientific publication, and reviewed by the FDA prior to dissemination. Although these restrictions will prevent manufacturers from disseminating misleading information, the regulations may be too restrictive by not allowing patients to benefit from other potential uses of certain medications. Certain medications may not have accumulated enough data to be approved for off-label use by the FDA, but may be a last resort option for some patients.

Language: en