OFF-LABEL PRESCRIBING

What does Off-Label Prescribing mean?

Sometimes drugs are approved for one purpose but can be prescribed by a doctor in what is called off-label use.

For example, a drug may be approved for one disease but studies might show that it’s effective for other uses. But the pharmaceutical company may decide that it’s not worth the money to conduct an expensive clinical trial to get this new drug approved for the other diseases. So, instead doctors may prescribe the drug “off-label”. Some physicians may agree to this and some may not.

Similarly, you may come across some very promising phase 2 studies and wonder why no phase 3 studies were done. Again, it might very well be that from a business standpoint it didn’t make sense for the pharmaceutical company to invest funds in the phase 3 study. For example, it might be because the market is too small.

Again, look and see what drugs were used. It might be possible, as I just mentioned above, to get these drugs in an off-label fashion.

Or, you might come across studies that were done in other countries that look promising and yet those same therapies were never tested in your country. Again, check to see if the drugs are approved for other purposes in your country.

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