Here's why off-label drug marketing is off the charts

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The AP reports on a Government Accountability Office analysis of FDA monitoring of off-label drug promotion - which means marketing of drugs for purposes for which they are not approved. Excerpt:

"The situation has raised concerns for Sen. Charles Grassley of 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."

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This page contains a single entry by Gary Schwitzer published on July 28, 2008 12:30 PM.

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