FDA Proposal on the Promotion of Off-Label Uses Highlights Drug Agency’s Recklessness

Feb. 15, 2008

FDA Proposal on the Promotion of Off-Label Uses Highlights Drug Agency’s Recklessness

Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen

The Food and Drug Administration’s (FDA) announcement today to once again permit the promotion of off-label uses of drugs contrasts the current recklessness of the agency with the more consumer-protective FDA of 10 years ago. In 1997, the FDA strongly opposed the principles in today’s guidance because they would have opened the door to the promotion of drugs for treatments for which there was not enough evidence that the benefits outweighed the risks. As a result, the law passed in 1997 – which was in place until October 2006 – 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. These safeguards will no longer be required under today’s proposal. 

Almost every week brings new evidence of the FDA’s dangerous attitude about the public’s health and demands a change in leadership at the agency, starting with the commissioner. Today’s proposal, if finalized, 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.

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