The court has decided against it and resulted in the FDA’s actions blocked by the lawsuit from Amarin, maker of prescription drug laced with fish-oil to tackle heart disease. It’s an early victory and one that is quite singular in fighting the Food and Drug Administration’s decisions.
The drugmaker company’s issue surrounds Vascepa, an FDA approved medication in 2012, meant for patients with very high levels of triglycerides used to lower a type of fat found in the bloodstream. While the drug itself has been approved for its purpose years ago, the agency rejected the drugmaker’s similar pill for people with lower triglycerides after taking statins, a drug frequently used to lower cholesterol.
The second use has been rejected by the FDA, but the company decided not to stop its attempts by promoting the medication as an ‘off-label’ use in spite of not getting the approval for safety and proper regulations. To explain the reasoning behind their decision, the agency called for a need for more research that lower triglycerides have the benefits of fewer heart problems.
While Amarin has not provided the proper information to pass its trials, it has still persisted upon promoting their drug for its ‘off-label’ use to magazines, journals or directly recommending it to doctors. The FDA suggested that the promotion by distributing information for unapproved usage of the drug is illegal, but the company filed a lawsuit against them in response.
It’s a matter of great controversy surrounding the practice of ‘off-label’ prescription. While the agency is not a stranger to approving such uses for various medications, it still remains a matter of debate since some are still used even if they remain unapproved. It cannot be stopped and it’s a reality the agency has to face every day.
Not all their decisions will be met without resistance, and Amarin has won the fight by claiming that the FDA violates the First Amendment, their right of speech and promoting their drug however they wish as long as it’s not misleading. It’s perhaps a matter of technicality, considering it’s not illegal for them to offer information about their own product.
The judged sided with the company in 71-page long document, stating that “Amarin may engage in truthful and non-misleading speech promoting off-label use of Vascepa.”, meaning that the information for unapproved usage is legal as long as it’s not misleading.
Analyst Ira Loss has implied that the lawsuit might’ve been an issue of vanity from Amarin, as the FDA would’ve permitted many of the company’s plans if they had passed them through proper regulators first.
All could have been resolved in a matter of weeks, according to Loss, with no hassle, but if the company insists to “strut and think they accomplished a great achievement by beating the FDA in court, they’re free to do it.”.
Image source: gizmodo.com