FDA Faulted over unapproved uses of medications

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.

Source: Associated Press, Yahoo News.

Source: http://news.yahoo.com/

Comments: There is increasing need to monitor the off-label use of prescription medications. Insurance companies question the necessity to pay for these medications, while doctors need to use independent judgment for such use to match the individual patient's requirements. Of course the drug industry has tremendous interest in the off-label promotion of drugs, because of expansion of drug use. Unfortunately the FDA has not allotted enough resources to monitor all such unapproved prescriptions. As this article mentions, 44 FDA employees scrutinized 68,000 printed ads last year. In addition to printed ads, other media resources such as the Internet and television advertisements often go unnoticed by the FDA. The pharmaceutical companies promote off-label prescription drugs through methods such as sponsoring continued medical education, providing physicians with journal publications, and so on. These practices by the pharmaceutical industry fully utilize the ambiguities in the FDA policies. However, this article emphasizes the inefficiency of the FDA monitoring practices, and the drug companies enjoy the benefits of 20% more profits through off-label use.

The FDA is supposedly a regulatory agency, but it is chronically under funded and depends on pharmaceutical companies in the form of fees for funding. With such a huge conflict of interest it would be hard to imagine that the FDA watches out for consumer health instead of the benefit of the pharmaceutical companies.

For more than a decade, Dr. Rath has continued to unveil the pharmaceutical industry's "business with disease" tactics through direct or indirect means to improve their profits. Please read more about this and join the efforts of the Dr. Rath Health Alliance at www.drrathhealthalliance.com