BMJ  2005;330:435 (26 February), doi:10.1136/bmj.330.7489.435

News

FDA's safety reform is greeted with scepticism

Ray Moynihan

Sydney

The first 150 words of the full text of this article appear below.

The US consumer watchdog group Public Citizen has described the creation of a new safety body at the Food and Drug Administration as a "desperate" and "cynical" attempt to respond to public alarm about the harms of prescription drugs.

Last week the FDA announced that it will set up a new drug safety oversight board, made up of experts from government agencies, including the FDA, to "oversee the management of drug safety issues" and provide information to doctors and patients more quickly than in the past. The board will not get involved in assessing drugs before approval but will concentrate on improving the way the FDA monitors and disseminates information about adverse events.

The move comes after a series of controversies involving the safety of hormone replacement therapy, antidepressants, antiarthritis drugs, and, most recently, a drug used to treat attention deficit hyperactivity disorder, atomoxetine, which has been linked to rare . . . [Full text of this article]


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