Thu, Jul 31, 2008 (2:03 a.m.)

Drug companies are prohibited by law from promoting their prescription medications for uses not approved by the Food and Drug Administration. Despite the law, “off-label” uses of prescription drugs have flourished.

Although drug companies are restricted from directly marketing their medications for anything but approved uses, doctors can use their judgment when prescribing medication. And off-label uses are widely accepted in the medical community. A study done in 2006 reported that one of every five prescriptions written in America was for an off-label use of a medication.

For example, the drug Provigil was approved for use in the treatment of narcolepsy, but Provigil’s sales skyrocketed as doctors have used it for depression, attention deficit disorder, cocaine addiction, general fatigue, jet lag and Alzheimer’s disease.

Off-label uses are lucrative for drug makers, who have pushed for more freedom in promoting unapproved uses of their drugs. This year the FDA allowed drug companies to start giving doctors scientific articles on off-label uses of drugs.

The problem, health advocates say, is that there is no guarantee the drugs will work because they haven’t been through wide-ranging clinical trials for alternative uses.

Sen. Chuck Grassley, R-Iowa, asked the Government Accountability Office to investigate, fearing that Medicare and Medicaid are spending billions of dollars of taxpayer money for drugs that don’t work as intended.

As the Associated Press reported this week, the GAO found that the FDA doesn’t have anyone fully dedicated to policing off-label use of drugs. The agency has also been slow to act. The GAO found that when the FDA does find a violation, it takes seven months on average to issue a warning.

“As a result,” Grassley said, “drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

The FDA’s failure cannot be allowed to continue. Congress should make sure the FDA has the resources needed to do its job and keep the public safe.