Off-Label Drug Use Needs Strong Oversight

[Celebration]

http://www.washingtonpost.com/wp-dyn/content/article/2008/04/02/AR2008040202699.html

WEDNESDAY, April 2 (HealthDay News) -- U.S. Food and Drug Administration draft guidelines for oversight of off-label drug use would allow pharmaceutical companies to market more drugs for unapproved uses, one expert contends.

The proposed guidelines are a step in the wrong direction, Dr. Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center, wrote in an editorial published in the April 3 issue of theNew England Journal of Medicine.

While the FDA approves drugs for specific purposes, doctors can use drugs off-label to treat other medical conditions that aren't included in the FDA approval. This is common practice, but what's known about the use of a drug for one condition may not apply to other situations, said Stafford, a Stanford University School of Medicine researcher. The use of antipsychotics for dementia and the use of antidepressants in children are key examples, he noted.

Stafford doesn't believe the FDA should start telling physicians how to practice, however. He said that physician judgment in such cases is critical, and off-label use of drugs can be helpful in certain cases where patients don't respond to approved therapies.

"But in other cases, off-label prescribing has become first-line therapy even in the absence of strong evidence of benefits and safety. This is problematic," Stafford said.

[merwin]

1. I don't have a problem with Off-Label prescribing in most circumstances.

[Fovea]

2. I think sometimes it is needed

My doctor is limited by his hospital's formulary.