More Bush legacy BS: FDA approves more potentially deadly off-label drug use
How much of this crap does Obama have to roll back? Here’s another of the “improvements” to government done at the midnight hour by our last president. (McClatchy):
In the waning days of the Bush administration, the Food and Drug Administration finalized 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 also was crafted despite efforts by state and federal law-enforcement experts to clamp down on off-label drug marketing.
The new guidelines were issued four years after Robin Briggs of Cornelius, N.C., buried her husband, Doug, who committed suicide on a chilly Christmas Day after taking a drug off-label.
Doug Briggs, himself a physician, had taken a drug that the FDA had approved to treat epilepsy to ease his persistent back pain. It didn’t do much for his back, but Robin Briggs said the drug’s risk of producing suicidal behavior led to his death.
Of course it’s legal for doctors to prescribe meds for off-label use, but it’s not for Big Pharma to pimp their drugs for that kind of use. Pfizer Inc. and Eli Lilly have been slapped with two of the largest settlements ever over off-label use gone wrong.
Congressional leaders from both parties criticized the guideline when it was proposed last year. Sen. Charles Grassley, an Iowa Republican who’s 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.”
“A legislative fix may be in order,” Grassley said Thursday.
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.