FDA Guidelines on Unapproved Drug Use Draw Criticis

By Staff

2/20/2009

US Pharm. 2008;34(2):6.

Rockville, MD -- The FDA has issued final guidelines on the distribution copies of published articles that refer to unapproved uses, often referred to as off-label uses, for drugs and medical devices. According to a report from Reuters, the guidelines are drawing objections from congressional Democrats and drug-industry critics. The guidelines were adopted before former President Bush left office. While the FDA believes the new guidelines will expand the markets for medicines and medical devices, several legislators believe it undermines the need for pharmaceutical companies to first prove to the FDA that a particular use for a drug is safe and effective. Sidney Wolfe, director of Public Citizen's Health Research Group, is calling on President Obama to reverse the decision.

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