The Food and Drug Administration is redrafting its guidance that allows manufacturers to distribute journal articles that discuss unapproved uses of FDA-approved drugs and medical devices.
The draft guidance recommends principles that manufacturers should follow when distributing scientific or medical journal reprints, articles or reference publications. The guidance specifically recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article.
When a drug manufacturer gets approval from the FDA, it must sell the drug with a label that lists only its approved uses. Any other use is referred to as off-label.
The FDA in a previous guidancewhich was enacted in 1997 and expired in 2006had required companies to submit medical journal articles in advance to the FDA and agree to file within three years a supplemental new drug application for the off-label use it wanted to promote.
Yet, these important safeguards are nowhere to be found in the new proposed guidance, said Sidney Wolfe, director of Public Citizens Health Research Group, in a written statement.
If finalized, the FDAs new guidance constitutes a health threat because it encourages drug companies, who have no reason to fear FDA sanctions, to promote drugs for purposes not proven to be safe and effective, Wolfe said.
The FDA will be accepting comments on the draft guidance 60 days after its publication in the Federal Register. -- by Jennifer Lubell