Resources for Food and Drug Administration (FDA)

F.D.A. Plan on Medical Articles Takes More Heat

www.nytimes.com

The pharmaceutical industry glimpsed its own ghost this week, and the apparition could not have arrived at a worse time for drug makers.

A report indicating that Merck used ghostwriters to produce medical journal articles in support of its subsequently discredited drug Vioxx has galvanized opponents to a federal proposal that would relax some restrictions on drug promotion.

The Food and Drug Administration has been considering a proposal to let drug makers use reprints of journal articles in promoting drugs for so-called off-label uses the F.D.A. itself has not approved. A main proviso of the proposal is that the articles must have been published in peer-reviewed medical journals.

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