FDA falls down on off-label prescribing
I wonder if we've progressed much from the 19th century, when quacks rolled through the countryside on horse-drawn wagons. On the side of the wagons was painted in gaudy gold letters the pitch for the latest miracle elixir.
The quacks now are huge pharmaceutical companies with billion-dollar advertising budgets. And, to top it off, sometimes the pitch is off target — perhaps a remedy for something a bit removed from what the initial research was testing and what the FDA was approving.
The sad thing is that it's catching on. More and more docs are prescribing drugs to treat conditions that the drugs were not approved to treat. How do doctors learn about these possible alternate uses? You guessed it – their friends at the drug companies.
It's called "off-label" prescribing, and the government couldn't be taking it less seriously. If federal regulators catch a drug company selling medications for an unapproved use, it takes an average of seven months for the FDA to formally warn it, according to a new report from the Government Accountability Office. Then it's maybe a few more months for the drug company to fix the problem. In the meantime, a lot of scripts are being written.
Docs should be aware that off-label prescribing amounts to an uncontrolled experiment, turning patients into guinea pigs. It's not an experiment I would risk — particularly without explaining the pros and cons to a patient. Drug companies are forbidden to promote medications for uses without validation by the FDA on evidence from clinical trials. Doctors, however, are empowered to use their own independent judgment in prescribing drugs. The abuse is widespread enough to draw the attention of Congress. Sen. Charles Grassley of Iowa is looking into programs such as Medicare and Medicaid, which are shelling out billions for medications used for questionable purposes. That's a lot of profit for Big Pharma for pills that fall into this gray area. Indeed, a 2006 study suggested that more than one-fifth of U.S. prescriptions are written for off-label—and oft-dangerous—use. Grassley requested the accountability office look at the practice out of concern that the FDA is woefully under-prepared to monitor illegal off-label use marketing.
Considering that they're challenged with keeping tabs on the safety of on- label use, I'd say the odds are good that this is the case.
