Off-label use is when a drug is fully FDA approved for safety and for a particular purpose,
but it's used or prescribed for a purpose or a patient population or a dosage that's
different from what the FDA approved.
Pharmaceuticals are only approved for particular purposes.
This is because the FDA requires all pharmaceuticals to be approved not just for safety, but also
for efficacy.
That means that to be approved by the FDA for a particular use, a drug or a medical
device has to go through that 10-15 year approval process for each particular use that the pharmaceutical
company wants to market it.
Today about one in five prescriptions are prescribed off-label.
But even though the treatments are legal, the FDA prohibits pharmaceutical companies
from sharing truthful information about those off-label uses with doctors, with insurance
companies, and with patients.
But why would the FDA want to prohibit the exchange of information that is perfectly
truthful?
Under 21 USC 352 it is illegal for a pharmaceutical company to misbrand a drug or other medical
device.
Federal law defines misbranding as when the label for the particular treatment does not
include adequate instructions for use.
The FDA, however, interprets its enforcement authority of this law very, very broadly.
Any time a pharmaceutical company shares information about an off-label or unapproved use of that
treatment, even if the information that the pharmaceutical company is sharing with doctors
or patients is perfectly truthful, and not misleading.
Nevertheless, the FDA considers that to be misbranding.
Branding is a form of speech.
After all, it's just speech that is used to sell a product or promote an idea in exchange
for money.
In the Virginia Board of Pharmacy decision, back in 1976, the United States Supreme Court
said it was critical to protect speech, regardless of whether or not it was made for a commercial
motive.
The court said, "Speech is not dangerous or harmful in itself, and consumers need to
make decisions for themselves, and can only make those decisions when they're fully informed".
The best argument against off-label promotion goes this way: patients oftentimes are not
able to make the best decisions for themselves.
Perhaps they have a lot of information at their disposal, but they are biased.
They may be concerned about their own welfare, they may be scared, they may be desperate.
Pharmaceutical companies, on the other hand, have a financial motive.
They want to sell their products to doctors and to patients, and so they may also be biased,
and therefore, we need a neutral arbiter, somebody like the FDA to come in and make
these decisions.
And the best way that the FDA has decided to make these decisions, is to control the
type of information that gets shared.
The best argument for off-label promotion is simply this: lack of information can be
deadly.
When people don't have all the information that they need to be able to make informed
decisions, they oftentimes don't make informed decisions.
If pharmaceutical companies aren't able to freely share the most cutting edge, up to
date information that they have, and only they have, about treatments, then those people
who are making decisions that affect a person's life will never be able to make decisions
in the most informed way.