http://www.newsday.com/news/health/ny-hsjama234052435nov23,0,6121212.story?coll=ny-health-headlines~snip~
Arguing that the country's system for monitoring drug safety is haphazard and ineffectual, editors of a leading medical journal called for a radical overhaul yesterday and suggested the creation of a new independent drug safety board.
The bluntly worded editorial in the Journal of the American Medical Association says the country's surveillance system of prescription drugs on the market is inherently flawed, as it largely relies on pharmaceutical manufacturers to investigate the adverse effects of their own products.
"The drug approval process must be decoupled from the post-marketing safety and surveillance system," the editorial says. "It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong."
In response, a U.S. Food and Drug Administration official said the editorial proposal "warrants serious consideration." But, he said, the Institute of Medicine, an arm of the National Academy of Sciences that advises the government on health issues, has already been asked to study the system. The editorial noted that the institute's study would take too long to complete and that urgent steps were needed to restore confidence in the FDA.