Off-label: the use of drugs to treat conditions other than the ones
the drugs were FDA approved for

Example: Geodon is a powerful antipsychotic drug. Against its own
Medicaid rules, Florida wasted nearly $6.5 million tax payer dollars
from 2003-2007 for this drug on kids despite the fact this drug is not
FDA approved for children at all. Short clip here:
http://www.youtube.com/watch?v=7ibwZJJXAWU

Here is a snapshot (2005) of what Florida Medicaid was allowed to pay
regarding antipsychotic drugs on children:
www.psychsearch.net/atypicals.html

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Associated Press
FDA faulted over unapproved uses of medications
By RICARDO ALONSO-ZALDIVAR
July 27, 2008

WASHINGTON — 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
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 while
bulking up the bottom line for pharmaceutical companies. Indeed, a
2006 study suggested that more than 20 percent of prescriptions
written in the United States are for off-label use.

The review that Grassley requested by the investigative arm of
Congress found that the FDA is ill-equipped to catch even blatant
marketing abuses by drug companies. The agency does not have any staff
exclusively assigned to monitor whether companies are following the
rule against marketing drugs for unapproved uses.

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," 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."

Instead, the job is handled by the office that oversees all drug
advertising, including television commercials and magazine ads. That
office has 44 full-time employees assigned to review ads. Last year,
they had to dissect the fine print on some 68,000 advertisements.

The office tries to set priorities, by focusing first on
misrepresentations that could have a damaging impact on human health.
But the report found that the FDA lacks a system for tracking all the
material it receives.

From 2003-2007, the office issued 42 notices of possible violations,
which usually prompted the drug maker to drop its promotional claims.
The cases included a drug approved for breast cancer and rectal cancer
that also was being promoted for treatment of gastric, cervical,
uterine, ovarian, renal, bladder, thyroid and liver cancers.

An additional 11 cases involving off-label promotions wound up in the
hands of the Justice Department during the same period. Last year, for
example, Bristol-Myers Squibb Co. agreed to pay the government more
than $500 million to settle claims involving a series of alleged
infractions, including promoting the drug Abilify — approved to treat
schizophrenia and bipolar disorder — for treatment of dementia-related
psychosis and for use in treating children.

Link:
http://ap.google.com/article/ALeqM5jnQw3m0uHGLdqBwnY4EOOPLL0RkgD926945G0