To get a drug approved by the U.S. Food and Drug Administration (FDA) for a particular problem or condition, pharmaceutical companies generally spend hundreds of millions of dollars. They also spend millions on drugs that never get approved, it’s truly a hit or miss industry. It’s no wonder they savor every moment achieved through marketing their new drug to doctors and consumers.

The problem comes a few years later, when additional research has been conducted on the medication, and it becomes apparent that it may also have beneficial effects for other conditions. I’m not really sure how this begins, as I can’t imagine a doctor looking at a new medication and saying, “Hey, I wonder if Drug X, which was approved for Condition A also works on Condition B?” since there are literally hundreds of conditions a drug could be prescribed for. It’s a mystery to me.

But somehow, research is done that finds the new drug may also be effective for Condition B (and maybe even Conditions C and D).

Now, if that research is really strong and suggestive, the drug company might pour more money into R&D into conducting the kinds of specific research trials that the FDA requires for an existing medication to be approved for additional conditions.

A lot of times, however, the research isn’t that strong or, for whatever reasons, the pharmaceutical company doesn’t want to spend the extra money to get the additional FDA approval (because it is still substantial amount of resources that need to be committed).

It is during these times (or times when the company is waiting on formal FDA approval for an additional condition) that things get a little murky for drug companies. They know or suspect their drug is also useful for these other conditions, and know that doctors are already prescribing the drug for these conditions, despite there being no FDA approval to do so. This is called off-label prescribing and it is a common practice among virtually all physicians. It is not illegal, but it is one of those gray areas that almost begs for abuse.

So naturally, abuse occurs.

Drug companies can’t market their drugs for off-label uses — e.g., prescribing the drug for a condition that hasn’t been approved by the FDA. But apparently, some states like Arkansas, believe that some drug companies haven’t been playing by the rules and have been marketing some drugs for off-label uses. Furious Seasons has the story. Pharmalot, a blog focused on the pharmaceutical industry in general, has more information too.

Many physicians wouldn’t be surprised by such lawsuits, since they have been on the receiving end of soft off-label marketing for some drugs for years. It’s often done verbally by pharmaceutical salespeople in private meetings in the doctor’s office. It is also done in CME presentations where small research studies are mentioned that show “promise” for the drug’s additional uses in unapproved conditions.

I’m not sure whether these are widespread abuses, as the states claim, or something else, so I hope the lawsuits move forward to give us some insight into the nature and scope of these practices. They are unlawful and, I would think, completely unnecessary. Good drugs often market themselves and doctors know which ones they are.

Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

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Provigil for Bipolar Depression - World of Psychology (9/25/2007)

    Last reviewed: By John M. Grohol, Psy.D. on 24 Sep 2007
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