Are they safe drugs? Are they effective? Those are the 2 major questions that the FDA asks. Without a “yes” for both, the FDA won’t approve that use for a drug.
On March 10, 2016, it was announced that Amarin’s suit against the FDA has been settled and both have agreed to live with the previous federal court ruling. That ruling was that the FDA could not prohibit Amarin’s truthful promotion of a drug for off-label (unapproved) uses because doing so would violate the protection of free speech.
Is this a win for our First Amendment? Not in my opinion. I believe that public safety and health trumps free speach: The FDA is concerned that the drug is not effective or safe outside of the use for which it has been approved.
The FDA reviewed the new drug application for a prescription strength fish oil drug, Vascepa. The drug lowers triglicerides, a type of fat in the blood. High triglicerides are corrolated with a high risk coronary artery disease. However, the manufacturer Amarin, did not prove that lower trigliceride levels prevented heart disease or heart attacks. If it doesn’t do that, there is no point in taking it.
In the absense of proof that lower trigliceride levels can save lives, the FDA approved Vascepa for use only in the case of (and to be marketed for) those with very high triglicerides, but not for those with high or slightly high levels.
Doctors are not restricted to prescribing Vascepa only for very high triglicerides. As with any drug, doctors can prescribe them as they find appropriate. This kind of off-lable prescribing is both legal and common because the FDA has no jurisdiction over doctors, only drugs.
I hope doctors very carefully consider the FDA’s reasons for limiting the approval for any safe drugs before they go off label and here’s why — the concern with “free speech” in this and similar cases is that pharmaceutical reps and doctors who are paid by drug companies to promote are alllowed to reveal only the studies with the best results. Free speech does not require that the reps give doctors the full story or all of the studies. They just can’t lie about the studies they do show. And why wouldn’t they ignore the negative or unfinished/unpublished studies? Their job is to get the doctor to prescribe more of the drug they are selling.
The time crunch on doctors has been well-documented. To expect them to conduct full research on every drug that is used off label (and you’d be shocked at how many are used off label) is unreasonable. But it is reasonable that doctors limit their sources of information only to independent experts. Drug reps and docs who are paid by the drug companies to promote drugs are anything but independent and their speech is not “free,” it’s paid for.
Here’s a good article from FDA Law blog for more detail about the FDA/Vescepa approval history.
