Recently, there have been several high profile cases of government prosecution of off-label usage of medication. Is the government and the FDA in the best position to decide what the labeling should be for medication? Let's take a look at a few cases:
1) J&J is being prosecuted for off-label promotion of Risperdal to elderly patients with dementia. In April, an Arkansas judge ordered J&J to pay $1.1B in damages for J&J's illegal promotion of the drug.
2) Abbott Labs was ordered to pay $1.6B for off-label promotion of Depakote for agitation and aggression in patients with elderly dementia and to treat
schizophrenia. The FDA did not approve either use.
3) The government engaged in a four-year investigation of Medtronic to determine if Medtronic promoted off-label uses of the drug. Recently the government found no evidence of wrongdoing.
All of the news articles paint the defendant companies in a negative light. But, lack of FDA approval of for certain indication does not mean that a particular drug / device cannot be effective for that situation. There are two important things to note:
1) Other countries' regulatory bodies may approve that use.
2) Approval / labeling for a product is heavily dependent on the process and individuals involved in this process.
The FDA has been notorious for employing people in the review process who have little knowledge of the product / therapeutic area in question. Secondly, data from a clinical trial can be interpreted in several ways - while some would view the trial as effective, others would not.
Because of these reasons, doctors and other medical professionals are free to use products however they wish as long as it is in the best interests of patients. So, when government prosecutors accuse companies of "putting profits before patients," don't be too quick to buy into this statement and vilify companies.
I believe that health care data on product safety and effectiveness should be open and easily accessible to the public. This data is already available (see sites like clinicaltrials.gov) - but perhaps it could be portrayed more simply for the masses to understand. Ultimately, health care providers, and more importantly, patients, should determine which products to use.
Government prosecutors would love to paint health care companies as greedy entities out to mislead and gouge patients. However, my perspective as an insider is quite different. The companies I have worked for are extremely cautious about not promoting off-label uses. Our hands are tied. The products we make are likely applicable in many more situations than they are approved for. However, clinical trials are too costly to be undertaken to get those additional indications. While government prosecutors could accuse companies of profiteering, the public could accuse these same prosecutors of filing frivolous lawsuits as a means of raising money for their departments and the US government.
So where does this rampant prosecution of off-label promotion leave the health care industry and the US?
US health care companies do not feel supported by their own government. They feel that their hands are tied at every step. Contrast the exorbitant costs of commercializing a product in the US to the relative ease of commercializing the same product in Australia. Product application in Australia is many years ahead of the US. Suffice it to say that health care companies wish that all countries could be like Australia.
