WASHINGTON (AP) — 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
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