Off label use: The FDA knows better than physicians and drug companies

According to an article in August of 2006, the Annals of Internal Medicine stated the following: Off-label use is the common practice of prescribing a drug for an indication other than those approved by the FDA. The physician rationale for prescribing off-label is often based on the lack of FDA-approved effective treatments, reports of clinical effectiveness for the off-label use, or both.

A recent study confirms that off-label prescribing continues in earnest, with 21% of drugs listed in a data set being prescribed for off-label uses, most with little scientific evidence of efficacy. Although the responsibility for seeking FDA approval for adding new uses to the product label resides solely with the manufacturer, companies are reluctant to invest the resources necessary to develop the evidence required for FDA review, particularly when the off- label uses are already profitable.

In addition another article in the Archives of Internal Medicine found off-label medication use is common in outpatient care, and most occurs without scientific support.

So what does this mean? It means that physicians are doing what they feel is in the best interests of their patients. They don’t have a lot of confidence in the FDA or pharmaceutical representatives to give them the information they need to make decisions based upon what is best for their patients. It’s ironic that at a time when physicians chose to use more and more drugs off label that the drug industry is prohibited from supplying them more information because that is considered “off label marketing”.

As the screws tighten on the drug industry dollars and more fines are levied against the drug industry for off label marketing physicians are going to have to turn to each other more and more and rely on the drug industry less and less. Rather than take an investigational approach to the benefits of off label marketing the FDA has decided to hold to its narrow view that the label is the label and nobody can stray from the approved label. They see off label marketing as a benefit to their balance sheet not to patients but this is a sad mistake because if we trust physicians to do what is best for patients then we also have to trust them when they believe a medication can be beneficial when used off label.

Once again in trying to protect patients the FDA may have actually hurt them as they try and reign in off label use because after all they know best, not physicians or drug company medical people. The reality is that drug companies don’t have the financial resources or time to conduct new clinical trials for existing drugs. It would take too much time because the clock on patent expiration is ticking regardless of what new indications are added to the label