On Friday, a federal judge stated that the US FDA (Food & Drug Administration) cannot stop a drug’s truthful promotion for its unapproved uses. According to the judge, if FDA does so it will be violating the “protection of speech”.
The above-mentioned verdict by a Manhattan district judge might inhibit FDA’s ability of regulating pharmaceutical marketing from all possible corners. The past few years have seen pharmaceutical firms collectively pay huge fines after they were found to be promoting drugs for uses not approved by the FDA.
Lawyers representing pharmaceutical firms stated that it’s not yet the right time to say whether this ruling will be a far-reaching one. This is because the current ruling technically applies just to the Manhattan district, where it got handed down.
Although the FDA has not yet commented on this matter, the lawyers are expecting the organization to appeal. It is believed that right now pharmaceutical companies will act cautiously about promoting unapproved uses of their products openly. However, Amarin will not do anything like that.
Friday’s ruling is a big win (might be temporary though) for the small drug firm Amarin. The company is known for selling Vascepa, a drug used for treating high levels of triglycerides in the blood.
Amarin has announced that it will now be promoting Vascepa’s use for treating patients with lower triglyceride levels. Previously, FDA refused to approve this use of the drug.
For those who don’t know: constituents of Vascepa include a certain type of omega-3 fatty acid, which is also present in fish oil. The drug got FDA approval in 2012 for treating people with excessively high levels of triglyceride; to be more precise, for patients with over 500 mg of triglycerides in a deciliter of blood. Amarin wanted the FDA also to approve the use of the drug for patients with persistently high triglyceride levels that ranged between 200 and 499.
In court, Amarin was represented by Cahill Gordon and Reindel lawyer Joel Kurtzberg. According to Kurtzberg, this is the first decision ever to unequivocally and clearly rebuff the US government’s view that prosecution of off-label promotion is possible even if it’s non-misleading and truthful.
Doctors can use drugs approved by the FDA in ways that haven’t yet got the nod from the agency. Such off-label uses are pretty common. However, the government, since a long time, has been prohibiting drug manufacturers from promoting off-label uses of drugs manufactured by them.