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Originally published February 23 2009

Dangerous "Off-Label" Prescribing Illegally Marketed By Drug Companies

by David Gutierrez, staff writer

(NaturalNews) The FDA has little ability to police illegal marketing of drugs for unapproved uses, a report from the federal Government Accountability Office (GAO) has warned. This means that an illegal and potentially dangerous practice that is believed to be widespread is going essentially unregulated.

"[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," said Sen. Charles Grassley, who commissioned the report. "As a result, drug makers aren't being held accountable for promoting unapproved use of medicine, and patient safety is diminished."

Federal law prohibits pharmaceutical companies from marketing a drug to either consumers or doctors for a use that has not been specifically approved by the FDA - also known as an "off label" use. This is because FDA approval of a drug use requires the completion of certain clinical trials; off-label uses have not been subject to this process, and there is no way to know if the drug actually works to treat the condition for which it is being prescribed.

In some cases, off-label uses may indeed help patients. But in other cases, they may actually cause harmful effects, or at best waste a patient's money.

Yet federal law also allows doctors to make the ultimate decisions on which drugs to prescribe, and therefore allows off-label prescriptions.

Yet a 2006 study suggests that more than 20 percent of all prescriptions written in the United States are for non-approved drug uses. And off-label prescribing can vastly increase the profits for pharmaceutical companies such as Cephalon, which saw surging profits once off-label prescribing of its narcolepsy drug Provigil took off for Alzheimer's disease, attention deficit disorder, cocaine addiction, depression, general fatigue and jet lag.

Drug companies have actively lobbied for more relaxed rules regarding off-label marketing. In response, the FDA has proposed new rules that would allow companies to provide doctors with scientific information concerning potential off-label uses.

Even so, Grassley and other pharmaceutical industry critics believe that overtly illegal marketing of drugs for off-label uses remains widespread.

Fear of legal consequences is unlikely to deter the practice. According to the GAO report, the FDA is simply not equipped to police off-label marketing practices, even the most blatant. Off-label marketing rules are monitored by the Division of Drug Marketing, Advertising and Communications (DDMAC), the same division that monitors all television, magazine and other drug marketing - approximately 68,000 ads in 2007. With only 44 full-time employees, DDMAC receives "substantially more materials than the agency can review," the report says.

Once the FDA has detected an instance of illegal off-label marketing, it takes an average of seven months for it to issue a warning letter, the GAO found, with an average of four more months before the company actually changes its behavior. In one case, it took 17 months for Reliant Pharmaceuticals to issue new promotional material after receiving a warning letter.

The FDA issued 42 warning letters over possible illegal off-label marketing practices from 2003 to 2007, all of which were resolved without calling on the Justice Department. In addition, 11 lawsuits were settled in that time period over off-label marketing by drug companies.

According to the GAO report, it is not just a lack of staff but a failure of organization that hampers the FDA's ability to enforce off-label marketing laws.

"FDA does not prioritize its reviews in a systematic manner, but rather relies on its staff to sort through large volumes of material and select submissions for review," the report reads. "FDA is also hampered by the lack of a system that consistently tracks the receipt and review of submitted materials. To address these shortcomings, GAO recommended in 2006 that FDA track which materials it has reviewed. FDA has not acted on this recommendation."

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