Medical device and drug manufacturers are required to get clearance from the Food and Drug Administration prior to marketing their product to the public.
This clearance hinges on reams of clinical data, demonstrating safety and efficacy, and is predicated on very specific uses of the product.
For example, if a drug is approved for use as an anti-depressant, the drug can only be marketed as an anti-depressant.
Should other beneficial uses be discovered, the manufacturer must submit applications to the FDA, along with supporting data, to secure permission to market the drug as a treatment for a new condition.
However, and this is usually a surprise to most people, the FDA does NOT regulate health care professionals or hospitals.
Doctors are free to utilize products in any way they see fit, subject to their own liability.
This is called 'off-label' usage, and is not uncommon.
For example, the drug Gabapentin, manufactured by Pfizer, is approved to treat seizures, but has been found to be effective for a number of other disorders, including neuropathic pain.
Doctors began prescribing it for conditions beyond the treatment of seizures, and this is perfectly legal under US law.
Unfortunately for Pfizer, these off-label uses represented an increase in demand, and the company began to actively notify doctors of these off-label uses.
Essentially, the company was found to be marketing the drug for conditions not approved by the FDA.
In 2004, the company paid a $340 million fine for violating FDA law.
While off-label usage is not always a bad thing, medically speaking, it does complicate the efforts of consumers to stay informed about what products they are using.
Products may be manufactured correctly, marketed properly, and comply with all FDA guidelines, yet still used in ways that introduce risk to the consumer.
Doctors are not infallible, and it is healthy to challenge them and push for explanations regarding any treatments they prescribe.
Remember: What do they call the person who graduates dead last in their medical class? Doctor.
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