Drug Labels: Free Speech Yes, Dangerous Speech No
The U.S. Court of Appeals for the Second Circuit just overturned the conviction of a drug sales representative promoting off label use for a narcolepsy drug that included fibromyalgia, restless leg syndrome and insomnia (use for drug not approved by FDA). The Dec 3 court decision determined that this falls within the realm of free speech and should be protected. So, they overturned the sales reps 2008 conviction of introducing a misbranded drug into the market.
So is it really just about free speech?
Many off label uses for drugs may be similar in nature to the varying disease states. But the indications above could not be more far apart. Narcolepsy is a debilitating nervous system disease where you fall asleep uncontrollably. Insomnia is a state where you can not fall asleep at all.
Free speech should not harm your fellow citizens. That’s just dangerous speech. I don’t think the Constitution intended to encourage that.
Patients may be harmed by off label use of a drug that has not been clinically proven for that specific disease state. The drug companies are making hefty profits to cover more clinical trials to prove more uses for their medical health products. Off label use does may not always capture SAEs related to off label use. The new SAE’s encountered may not be included for addition to product labeling nor does it prove the off label treatment is effective for the “new use”.
Free speech is not free when the consumer purchases a prescription and is then injured by that drug. Far from free, the patient pays a big cost.
It is very difficult for the average patient to prove a specific drug caused them harm unless they are under a clinical trial where blood and urine samples are drawn regularly to keep track of their health.
I am certainly not against new safe and effective treatments, I am against snake oil salesmen touting panacea “cure all” drugs when in reality no such thing exists.
The False Claims Act for off label drug promotion is a very specific statute. It’s there to keep our medical health product manufacturers and innovators honest.
But false claims aren’t the only law being broken by some offenders. These other offenses include: Physician payout for prescriptions, suppressing risk of the treatment, fictitious clinical trials and price fixing.
There are many more schemes involved and here is a link alerting us to many recent false claims payouts that may break the half a trillion mark.
The FDA will appeal the recent court decision, and this may go to the U.S. Supreme Court for final disposition. But the question remains, will we go back to the snake oil salesman of yesteryear or move forward with transparent, safe and effective health care treatments?
Let’s remember why the FDA was formed over a hundred years ago. It’s about protecting the public health. Not about protecting dangerous speech.