FDA guidance for off-label use sparks controversy

As per the new FDA guidelines, the organization which publishes the articles must contain an editorial board. The organization should also fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. The FDA maintained that articles should be peer-reviewed and published in accordance with specific procedures.

But the new guidance sparked protests from the consumer healthcare organizations which feel that FDA is deviating from its consumer centric ideology of the past. According to Sidney Wolfe, director of the Health Research Group at consumer body Public Citizen, the decision to permit the promotion of off-label uses of drugs is indicative of the drastic change in FDA’s outlook.

Mr. Wolfe said that according to the new FDA guidance the companies no longer have the need 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. The consumer organizations fear that the market-oriented approach indicated by the FDA’s new guidance may have a pernicious effect on public health.