FDA issues guidance for the distribution of medical and scientific information on off-label drug uses

On Monday, the FDA issued new guidance for the distribution of medical journal articles and medical or scientific reference publications by drugmakers that address off-label uses of approved compounds.

The new recommendations are a finalised version of the agency's draft guidance, which was issued in February 2008. Among the new recommendations, the FDA stated that the medical publications should be "published by an organisation that has an editorial board that uses experts [with] expertise in the subject of the article under review ...and who are independent of the organisation to review and objectively select, reject, or provide comments about proposed articles."

Additionally, the agency said the new guidelines are designed to discourage ghostwriting, and they recommend that drugmakers disclose any financial relationships or affiliations with article authors. Furthermore, drug manufacturers will no longer have to submit medical journal articles on unapproved new uses of cleared products to the FDA before distributing the studies to physicians.

The agency "recognises that the public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products," according to the FDA document.

Commenting on the news, Pfizer and Eli Lilly stated that the guidelines reauthorise a longstanding practice that benefits physicians and patients.

To read more Top Story articles, click here.