FDA Faulted over Unapproved Uses of Medications

[Hissyspit]

Source: Associated Press

FDA faulted over unapproved uses of medications

By RICARDO ALONSO-ZALDIVAR (Associated Press Writer)
From Associated Press
July 27, 2008 4:40 AM EDT

WASHINGTON - When federal regulators catch a drug company peddling prescription medications 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 their 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.

Drug companies are forbidden to promote medications for uses that have not been validated by the Food and Drug Administration on evidence from clinical trials. Doctors, however, can use their own independent judgment in prescribing medicines. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications. The situation has raised concerns for Sen. Charles Grassley, R-Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes.

Read more: http://enews.earthlink.net/article/top?guid=20080727/488bf2c0_3ca6_1552620080727533446512

[livingon]

1. the FDA has been underfunded for years

[PSPS]

3. Plus it has a "loyal bushie" at the helm

You know the type -- hates the very idea of the agency itself and is charged with its destruction.

[Truth4Justice]

15. Am glad for that. They tried to make vitamins an RX item for years while Vioxx killed lots of folks

[pattmarty]

2. Does this REALLY surprise any of us here?

[pitohui]

5. not getting where is the problem -- i've benefited from off label use of medications

some of us are getting older and if we want to wait decades for the drugs to be completely approved by fda, we'll be dead, jim

i've had help and benefit in my life from off label uses

this should be between me and my doctor

not between me, my doctor, and a bunch of damn busybodies who don't want anyone younger than 20 to ever live long enough to have benefit of the new inventions and new drugs

[pattmarty]

6. Well, I'm 62 and use a lot of drugs too. Although most of my drugs.....

.....come from India via Canada. That is "where the problem is", we need vastly cheaper drugs and for the fucking FDA to AGAIN properly do its God Damn job.

[enki23]

4. there are a lot of good people working at the FDA

understaffed, underfunded, and too often with their hands tied by de facto political appointments at the top.

[pattmarty]

7. I agree, but with ALL the regulatory agencies they have been......

.....either castrated or are now serving the industries they were supposed to regulate. That's why the sooner we get a Dem in the White House and larger majorities in both houses we can begin to repair what our government did to us for the last 30 yrs.

[bluesmail]

8. They don't need to formally privatize the FDA.

It's so OBVIOUSLY transparently already done. I want off the planet. Peace

[Truth4Justice]

9. Q: why are the US drug cartels allowed to air those "ask your doctor" TV ads?

[depakid]

10. Because the Clinton administration decided that disease mongering at our expense was OK

back in 1997- and so changed the rules to allow direct to consumer ads to flood American airwaves.

It's still illegal in every other developed nation except New Zealand.

http://www.sourcewatch.org/index.php?title=Direct-to-consumer_advertising

[Truth4Justice]

14. They should be banned just like tobbaco ads. This country is fixated on drugs.

[crimsonblue]

11. off label is important

Doctors won't accept paper pushers dictating what they can and cannot prescribed.

[Psephos]

12. Snap out of the groupthink for a minute: off-label is an important freedom worth protecting

Comes down to this: you want some bureaucrat a thousand miles away deciding which meds you can use, or your own doctor?

[pop goes the weasel]

13. my daughter's seizure meds are all off-label

Not one thing she takes was designed for epilepsy, but they work for her. Only a worthless hate-filled bastard intent on minding everyone's business but their own would interfere with her being able to have the medication she needs. And if I had to get it on the blackmarket, I would.

[Truth4Justice]

16. At least you have the health insurance or money to pay for her treatment.

50 million of us don't have those options.

[pop goes the weasel]

17. She's an adult

Her seizures went untreated 2 years until she finally got qualified for Medicare.

[Truth4Justice]

18. I am truly sorry to hear that.