In the waning days of the Bush administration, the Food and Drug Administration completed new guidelines to make it easier for drug manufacturers to promote "off-label" prescription drug uses, which can be deadly for patients.
The move came despite criticism from Bush's own Department of Veterans Affairs, which said the change "favors business interests over public safety" and could lead to a "decline in drug safety." It was also crafted despite efforts by state and federal law enforcement experts to clamp down on off-label drug marketing.
As the Obama administration reviews all the midnight rules that the departing Bush administration issued, it will have to decide whether to try to modify or reverse this last-minute change in the FDA's oversight of off-label drug marketing.
Congressional leaders from both parties criticized the guideline when it was proposed last year.
Sen. Charles Grassley, an Iowa Republican who has repeatedly investigated the FDA, said he had serious concerns about the proposal, which he said would deem appropriate something that "the FDA once considered evidence of unlawful marketing."
In the House of Representatives, Rep. Henry Waxman, a California Democrat, called the guideline a "long-coveted parting gift" for the pharmaceutical industry that "fundamentally undermines" the FDA's authority.
More at The Baltimore Sun
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