Sun editorial:

A real drug problem

Federal government fails to keep up with unapproved uses of prescription medicine

Thursday, July 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.

Discussion: 3 comments so far…

By KDR81

7/31/08 at 8:50 a.m.

Suggest removal

We should shut down the FDA, there conservative nature keeps drugs off the market to long even after they're proven to work. This means thousands of Americans die each year waiting for a medicine to be approved by the FDA.

We're free people, we should be allowed to make adult choices.

Let the government punish fraud, not companies trying to improve peoples lives.
By azsk8fan

7/31/08 at 11:13 a.m.

Suggest removal

R U kidding me - free to make our own choices? Heck a business owner can't even make the choice to allow smoking in their own establishment and let the patrons decide if they do or don't want to patronize the business - a homeowner can't even make the free choice to whom they want to sell or rent their own home to without some bleeding heart screaming discrimination - the list of non-freedoms goes on and on. Wake up America!
By neiman1

7/31/08 at 7:05 p.m.

Suggest removal

I am more worried about someone inspecting my food. You can track a bale of cotton from a spinning mill in India or Taiwan back to the exact field and farmer that grew it . We can't even tell what country our food came from let alone whats in it.

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