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FDA faulted over unapproved uses of medications

Posted Nov 30 2008 12:20pm
FDA faulted over unapproved uses of medications
By RICARDO ALONSO-ZALDIVAR

WASHINGTON (AP) — 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.

The review that Grassley requested found 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.
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