July 28, 2008

FDA Unable To Regulate Off-Label Prescriptions

A report recently issued by the Government Accountability Office is shedding light onto 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.

When federal regulators discover a drug company that is selling prescription medications for unapproved use, it can take them an average of seven months to issue a warning, according to the new report. During that time, a lot of prescriptions can be written.

While some patients stand to benefit from the practice of off-label prescriptions, they are essentially part of an experiment. Some end up getting drugs that do not do them much good and end up wasting their money. Others stand the chance of being harmed by unexpected side effects of the drugs.

What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.

While drug companies are not allowed to offer medications for unapproved uses by the Food and Drug Administration, doctors are able to 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.

Sen. Charles Grassley, R-Iowa, says he is concerned 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.

A study conducted in 2006 showed that more than 20 percent of prescriptions written in the United States are for off-label use. The study also highlighted the FDA's inability to identify even blatant marketing abuses by drug companies because it doesn't have 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."

Those who are involved with keeping track of off-label drug use and marketing are part of a group of 44 full-time employees assigned to review advertisements, including television commercials and magazine ads.

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.


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