2010-09-16

Off-Label Promotion

Pharmatimes reports the following story, which is largely uninteresting from an industry perspective because such things are rather commonplace:
Forest Laboratories is the latest drugmaker to plead guilty to accusations of illegal marketing of its products in the USA.
Let me sum up the gist of this for industry outsiders: Forest Laboratories must pay a penalty for suggesting to doctors that their antidepressant products can treat more illnesses than just depression. That's it.

To be sure, doctors are not idiots. You can't just walk up to a doctor and say, "Hey, doc, guess what - you can cure cancer with aspirin, so please start diagnosing aspirin to cancer patients" and expect to sell more aspirin pills. Doctors, like most experts, require clinical evidence and logical, persuasive reasoning in order to become convinced that Drug X is a viable therapeutic option for Disease Y. Even then, there is no guarantee that a doctor will prescribe Drug X. The goal of a pharmaceutical rep is simply to make doctors aware of therapeutic options. If Drug X is an option, it's an option, period. The great crime here is that Forest Laboratories decided to do this in advance of an indication submission to the FDA.

Do you think this is a crime? Really? Then consider this...

When was the last time you shopped at a farmers' market? Are you aware of the fact that when you buy local produce from small farmers, those carrots and peas and bell peppers haven't been through the FDA-mandated inspection process? Are you worried that it will kill you? You're not, right? Why not? Because it's not FDA approval that determines the efficacy of products. It's biochemistry.

Before you suggest that drugs are "a big deal" and therefore "require" FDA approval, ask yourself when was the last time you used a Netti pot, ear candles, chicken soup, saline solution, echinacea, ginseng, zinc tablets, or any other home remedy to make yourself feel better. These things have no "FDA-approved indication" to treat your ailments, and yet you do not at all feel bad for consuming these products.

Furthermore, Forest Laboratories probably has good evidence for its products' efficacy in off-label applications.

People often demonize "Big Pharma" for supposedly not bringing life-saving treatments to market because they can supposedly make more money selling lesser treatments. But whose fault is it, really? Forest has safe products with proven efficacy, that they wish to apply to a new disease class, and this legitimate desire cost them over $300 million.

I don't want to be a shill, but it's important to keep in mind that it's pharmaceutical companies who produce medicine, not the FDA.