When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot.
When federal regulators catch a drug company peddling prescription drugs for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. During that time, a lot prescriptions can be written.
The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as “off-label” prescribing.
Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting money. Some people have been harmed by unexpected side effects.
What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.
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