THIS IS NUTS!!!!

November 24, 2008

WASHINGTON – The government is paying millions for risky medications that have

never been reviewed for safety and effectiveness but are still covered under

Medicaid, an Associated Press analysis of federal data has found.

Taxpayers have shelled out at least $200 million since 2004 for such drugs. Yet

the Food and Drug Administration says unapproved prescription drugs are a public

health problem, and some unapproved medications have been linked to dozens of

deaths. Millions of private patients are taking them as well, and their

availability may create a false sense of security.

The AP analysis found that Medicaid, which serves low-income people, paid nearly

$198 million from 2004 to 2007 for more than 100 unapproved drugs. Data for 2008

were not available but unapproved drugs still are being sold. The AP checked the

medications against FDA databases, using agency guidelines to determine if they

were unapproved. The FDA says there may be thousands of such drugs on the

market.

The medications are mainly for common conditions like colds and pain. They date

back decades, before the FDA tightened its review of drugs in the early 1960s.

The FDA says it is trying to squeeze them from the market, but conflicting

federal laws allow the Medicaid health program for low-income people to pay for

them.

Medicaid officials acknowledge the problem, but say they need help from Congress

to fix it. The FDA and Medicaid are part of the Health and Human Services

Department, but the FDA has yet to compile a master list of unapproved drugs,

and Medicaid — which may be the biggest purchaser — keeps paying....

That unapproved prescription drugs can be sold in the United States surprises

even doctors and pharmacists. But the FDA estimates they account for 2 percent

of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year.

Private insurance plans also cover them.

The roots of the problem go back in time, tangled in layers of legalese....

" The FDA does not appear to have a systematic mechanism to report these drugs

out, " said Jon Glaudemans, senior vice president of Avalere Health, a health

care industry information company, " and there doesn't seem to be a systematic

process by which health insurance programs can validate their status. And

everyone is pointing the finger at someone else as to why we can't get there. "

In most cases, doctors, pharmacists and patients are not aware the drugs are

unapproved....

[To access the full article, click the link above]

On the Net:

FDA's unapproved drugs page: http://tinyurl.com/4tv2sb

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