Furious Seasons

July 28, 2008

Slow Enforcement Of Off-Label Marketing Laws By FDA

A report issued by the General Accounting Office asserts that it takes the FDA seven months to catch instances of off-label marketing by pharma companies and issue a warning to the company and another four months for the company to correct its actions. Well, isn't that sweet?

Off-label marketing goes on all the time (20 percent of prescriptions are said to be for drugs Rx'd off-label), despite companies' instance that it doesn't (why all the Zyprexa lawsuits then?) and that's troubling for all kinds of reasons. It allows drug companies to make illicit profits and puts patients at risk. It also boosts the cost to taxpayers through Medicare and Medicaid.

"The FDA 'isn't keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it's the FDA's job to enforce that law,' [Sen. Charles] Grassley said in a statement. 'As a result, drug makers aren't being held accountable for promoting unapproved use of medicine and patient safety is diminished.'"

So who is minding the store?

Posted by Philip Dawdy at July 28, 2008 11:06 AM

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Comments

Well finally! someone noticed how useless the FDA is, and just wait until Grassley figures out there's pharma money involved there too!

Posted by: Stephany at July 28, 2008 11:50 AM

and it's the FDA's job to enforce that law,

That's true. Depending on the law it can be a catastrophic effect.
And FDA do other "jobs" that has nothing to do with health.

Posted by: Ana at July 28, 2008 10:20 PM

In my case, I'm very glad that my Neurologist does some off-label prescribing. Celebrex, by itself, did not help me, Cymbalta, by itself, did not help me, but the combo of meds has allowed me some pain relief and more mobility.

Would I want off-label marketing to include my story? No. Just like my DX is rare, so is my TX.

Even though it is an overused cliche`, the image of the snakeoil salesman in the old west continues to come to mind for me whenever I think of Pharma marketing - One WONDER PILL! that will solve everything from athlete's foot to exema. Phooey!

SMS

Posted by: Stiff Man Syndrome at July 29, 2008 08:46 AM